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Tenofovir Disoproxil Fumarate/Emtricitabine/Efavirenz Versus Combivir/Efavirenz in Antiretroviral-Naive HIV-1 Infected Subjects

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ClinicalTrials.gov Identifier: NCT00112047
Recruitment Status : Completed
First Posted : May 30, 2005
Results First Posted : October 13, 2010
Last Update Posted : October 13, 2010
Sponsor:
Information provided by:
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: Emtricitabine (FTC)
Drug: Tenofovir Disoproxil Fumarate (TDF)
Drug: Efavirenz (EFV)
Drug: FTC/TDF
Drug: FTC/TDF/EFV
Drug: Lamivudine/zidovudine
Enrollment 517
Recruitment Details Participants were enrolled at 70 study sites in the United States and Europe. The first participant was screened on 29 July 2003; the last participant was randomized on 16 January 2004; the last participant observation for the primary endpoint analysis was 11 February 2005; the last participant last visit for end of study analysis was 10 June 2009.
Pre-assignment Details Of the 517 enrolled participants, 6 received no study drug (the safety analysis set was therefore 511 participants: 257 [efavirenz+emtricitabine+tenofovir disoproxil fumarate group] and 254 [efavirenz+combivir group], respectively).
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Period Title: Randomized Phase
Started 257 [1] 254 [2]
Completed 187 166
Not Completed 70 88
Reason Not Completed
Lost to Follow-up             26             33
Adverse Event             10             10
Withrawal of consent             10             18
Sub-optimal virological response             3             13
Noncompliance             8             4
Protocol Violation             2             0
Pregnancy             3             1
Death             1             3
Hepatitis C treatment contraindicated             0             1
Inability to swallow pills             0             1
Incarceration             3             2
Moved out of State             0             1
Baseline NNRTI resistance mutations             4             0
High Hepatitis B DNA             0             1
[1]
Intention to treat (ITT) population N=255 (2 participants had received prior antiretroviral therapy)
[2]
ITT analysis population
Period Title: Atripla Phase
Started 160 [1] 126 [1]
Completed 142 106
Not Completed 18 20
Reason Not Completed
Adverse Event             2             1
Lost to Follow-up             5             7
Pregnancy             0             1
Death             0             2
Withdrew consent             7             7
Sub-optimal virological response             0             1
Non-compliance             1             0
Not specified             3             1
[1]
Number of participants who completed randomized phase and opted to roll over to Atripla at Week 144
Arm/Group Title EFV+FTC+TDF CBV+EFV Total
Hide Arm/Group Description

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Total of all reporting groups
Overall Number of Baseline Participants 255 254 509
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 255 participants 254 participants 509 participants
38  (9.9) 38  (9.0) 38  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 255 participants 254 participants 509 participants
Female
36
  14.1%
33
  13.0%
69
  13.6%
Male
219
  85.9%
221
  87.0%
440
  86.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 255 participants 254 participants 509 participants
White 142 156 298
Black 65 51 116
Hispanic 39 40 79
Asian 3 3 6
Not allowed to report 0 1 1
Other 6 3 9
HIV Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 255 participants 254 participants 509 participants
Asymptomatic 33 26 59
Symptomatic HIV Infection 117 127 244
AIDS 105 101 206
CD4 cell count  
Mean (Standard Deviation)
Unit of measure:  Cells/mm^3
Number Analyzed 255 participants 254 participants 509 participants
246  (171.9) 245  (156.6) 245  (164.2)
HIV-1 RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 c/mL
Number Analyzed 255 participants 254 participants 509 participants
5.03  (0.54) 5.00  (0.51) 5.01  (0.52)
1.Primary Outcome
Title Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time-to-Loss-of Virologic Response [TLOVR] Algorithm
Hide Description Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 48 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 48 visit (ie, the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 48 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV RNA levels < 400 c/mL prior to Week 48 visit.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intention to treat (MITT) analysis set included all randomized participants who received at least 1 dose of study treatment, no major protocol violations, and no baseline primary NNRTI resistance mutation (2 participants were not ART-naive at study start; 22 participants had NNRTI resistance mutations at baseline [MITT analysis set: 487])
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description:

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 244 243
Measure Type: Number
Unit of Measure: Percentage of participants
84.4 72.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments

Null Hypothesis: the percentage of responders (who achieved and maintained confirmed HIV-1 RNA < 400 c/mL [defined by the TLOVR algorithm]) through Week 48 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.

Alternative Hypothesis: the percentage of responders who achieved and maintained confirmed HIV-1 RNA < 400 c/mL [defined by the TLOVR algorithm]) through Week 48 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group.

Type of Statistical Test Non-Inferiority or Equivalence
Comments Assuming 70% response rate for each group at Week 48, 500 participants (250 per group) were sufficient to achieve at least 85% power to establish non-inferiority between the 2 study groups with a delta of 13%. The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was > −0.13.
Statistical Test of Hypothesis P-Value 0.002
Comments The difference and 95% CI are stratum-weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.
Method Cochran-Mantel-Haenszel
Comments No other adjustments were made.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 11.4
Confidence Interval (2-Sided) 95%
4.3 to 18.6
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 48 (Defined by FDA TLOVR Algorithm)
Hide Description Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 48 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 48 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 48 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV RNA levels < 50 c/mL prior to Week 48 visit.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
MITT analysis set included all randomized participants who received at least one dose of study medication, had no major protocol violations, and no baseline primary NNRTI resistance mutations (2 participants were not ART-naive at study start; 22 participants had NNRTI resistance mutations at baseline [MITT analysis set: 487])
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description:

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 244 243
Measure Type: Number
Unit of Measure: Percentage of Participants
79.5 70.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments

Null Hypothesis: the percentage of responders (who achieved and maintained confirmed HIV-1 RNA < 50 c/mL [defined by the TLOVR algorithm]) through Week 48 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.

Alternative Hypothesis: the percentage of responders who achieved and maintained confirmed HIV-1 RNA < 50 c/mL [defined by the TLOVR algorithm]) through Week 48 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group.

Type of Statistical Test Non-Inferiority or Equivalence
Comments The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was > −0.13.
Statistical Test of Hypothesis P-Value 0.021
Comments The difference and 95% CI are stratum-weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.
Method Cochran-Mantel-Haenszel
Comments No other adjustments were made.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 9.1
Confidence Interval (2-Sided) 95%
1.6 to 16.6
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 48.
Hide Description The percentage of participants with plasma HIV-1 RNA < 400 c/mL at Week 48. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis).
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) analysis set (Missing Observation or Switch in ART=Failure). ITT analysis set included all randomized participants who received at least one dose of study medication, and had no major protocol violations (2 participants were not ART-naive at study start [ITT analysis set: 509]).
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description:

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 255 254
Measure Type: Number
Unit of Measure: Percentage of Participants
80.4 69.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments Null hypothesis: The percentage of participants with HIV-1 RNA < 400 c/mL at Week 48 in the EFV+FTC+TDF group is more than 13% worse than the CBV+EFV group. Alternative hypothesis: The percentage of participants with HIV-1 RNA < 400 c/mL at Week 48 in the EFV+FTC+TDF group is no more than 13% worse than the CBV+EFV group.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was > −0.13.
Statistical Test of Hypothesis P-Value 0.004
Comments The difference and 95% CI are stratum-weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.
Method Cochran-Mantel-Haenszel
Comments No other adjustments were made
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 11.2
Confidence Interval (2-Sided) 95%
3.7 to 18.6
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 c/mL at Week 48
Hide Description The percentage of participants with plasma HIV-1 RNA < 50 c/mL at Week 48. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis).
Time Frame 48 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set (Missing Observation or Switch in ART=Failure). ITT analysis set included all randomized participants who received at least one dose of study medication, and had no major protocol violations (2 participants were not ART-naive at study start [ITT analysis set: 509]).
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description:

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 255 254
Measure Type: Number
Unit of Measure: Percentage of Participants
74.5 66.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments Null hypothesis: The percentage of participants with HIV-1 RNA < 50 c/mL at Week 48 in the EFV+FTC+TDF group is more than 13% worse than the CBV+EFV group. Alternative hypothesis: The percentage of participants with HIV-1 RNA < 50 c/mL at Week 48 in the EFV+FTC+TDF group is no more than 13% worse than the CBV+EFV group.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was > −0.13.
Statistical Test of Hypothesis P-Value 0.058
Comments The difference and 95% CI are stratum-weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.
Method Cochran-Mantel-Haenszel
Comments No other adjustments were made.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 7.9
Confidence Interval (2-Sided) 95%
0.1 to 15.6
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 48
Hide Description TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered “non-responders” on Study Day 1.
Time Frame Baseline to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description:

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 255 254
Measure Type: Number
Unit of Measure: Percentage of Participants
19 30
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments Null Hypothesis: The percentage of participants with Loss of Virologic Response through Week 48 is equal between the two treatment groups. Alternative hypothesis: The percentage of participants with Loss of Virologic Response through Week 48 is different between the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments The distribution of time to loss-of-virologic response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.
Method Log Rank
Comments No other adjustments were made.
6.Secondary Outcome
Title Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 48
Hide Description TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered “non-responders” on Study Day 1.
Time Frame Baseline to 48 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description:

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 255 254
Measure Type: Number
Unit of Measure: Percentage of Participants
23 32
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments Null hypothesis: The percentage of participants with Loss of Virologic Response through Week 48 is equal between the two treatment groups. Alternative hypothesis: The percentage of participants with Loss of Virologic Response through Week 48 is different between the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.046
Comments The distribution of time to loss-of-virologic response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.
Method Log Rank
Comments No other adjustments were made.
7.Secondary Outcome
Title Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 48
Hide Description Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.
Time Frame Baseline to 48 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description:

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 255 254
Measure Type: Number
Unit of Measure: Percentage of Participants
9 16
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA < 400 c/mL) at Week 48 is equal for the 2 treatment groups. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA < 400 c/mL) at Week 48 is different between the 2 treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.
Method Log Rank
Comments No other adjustments were made.
8.Secondary Outcome
Title Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 48
Hide Description Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.
Time Frame Baseline to 48 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description:

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 255 254
Measure Type: Number
Unit of Measure: Percentage of participants
16 24
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA < 50 c/mL) through Week 48 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA < 50 c/mL) through Week 48 for the EFV+FTC+TDF and CBV+EFV groups are different.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.063
Comments The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.
Method Log Rank
Comments No other adjustments were made.
9.Secondary Outcome
Title Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 48
Hide Description Change from study baseline to Week 48 in HIV-1 RNA in log10 scale (Week 48 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale).
Time Frame Study baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
As treated (AT) analysis set included all participants who received at least one dose of study medication and had not committed any major protocol violation.
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description:

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 201 172
Mean (Standard Deviation)
Unit of Measure: Log10 c/mL
-3.31  (0.54) -3.26  (0.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments Null Hypothesis: Changes from baseline through Week 48 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are different.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments The change from baseline to Week 48 in HIV-1 RNA was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from stratum-weighted Van Elteren test.
Method Van Elteren
Comments No other adjustments were made.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.05
Confidence Interval (2-Sided) 95%
-0.16 to 0.06
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 48
Hide Description Change from study baseline to Week 48 in CD4 cell count = Week 48 CD4 cell count value minus study baseline CD4 cell count value
Time Frame Study baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
AT analysis set included all participants who received at least one dose of study medication and had not committed any major protocol violation.
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description:

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 199 164
Mean (Standard Deviation)
Unit of Measure: CD4 Cell Count (cells/mm^3)
190  (111.7) 158  (107.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments Null Hypothesis: Changes from baseline through Week 48 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are different.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments The change from baseline to Week 48 in HIV-1 RNA was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from stratum weighted Van Elteren test.
Method Van Elteren
Comments No other adjustments were made.
Method of Estimation Estimation Parameter stratum-weighted difference
Estimated Value 31.74
Confidence Interval 95%
8.96 to 54.52
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 96 (Defined by FDA TLOVR Algorithm)
Hide Description Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 96 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 96 visit (that is, the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 96 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV RNA levels < 400 c/mL prior to Week 96 visit.
Time Frame 96 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Week 96 efficacy analysis set excludes Week 48 responders who did not consent after Week 48 visits from MITT analysis set (Week 96 efficacy analysis set: [463])
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description:

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 232 231
Measure Type: Number
Unit of Measure: Percentage of Participants
74.6 61.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments

Null Hypothesis: the percentage of responders (who achieved and maintained confirmed HIV-1 RNA < 400 c/mL [defined by the TLOVR algorithm]) through Week 96 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.

Alternative Hypothesis: the percentage of responders who achieved and maintained confirmed HIV-1 RNA < 400 c/mL [defined by the TLOVR algorithm]) through Week 96 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group.

Type of Statistical Test Non-Inferiority or Equivalence
Comments The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was > −0.13.
Statistical Test of Hypothesis P-Value 0.004
Comments The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from Cochran-Mantel-Haenszel test stratified on baseline CD4 cell count.
Method Cochran-Mantel-Haenszel
Comments No other adjustments were made.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 12.7
Confidence Interval (2-Sided) 95%
4.3 to 21.1
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 96 (Defined by FDA TLOVR Algorithm)
Hide Description Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 96 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 96 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 96 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV RNA levels < 50 c/mL prior to Week 96 visit.
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Week 96 efficacy analysis excludes Week 48 responders who did not consent after Week 48 visits from MITT analysis set (Week 96 efficacy analysis set: [465])
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description:

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 232 233
Measure Type: Number
Unit of Measure: Percentage of Participants
67.2 60.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments

Null Hypothesis: the percentage of responders (who achieved and maintained confirmed HIV-1 RNA < 50 c/mL [defined by the TLOVR algorithm]) through Week 96 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.

Alternative Hypothesis: the percentage of responders who achieved and maintained confirmed HIV-1 RNA < 50 c/mL [defined by the TLOVR algorithm]) through Week 96 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group.

Type of Statistical Test Non-Inferiority or Equivalence
Comments The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was > −0.13.
Statistical Test of Hypothesis P-Value 0.158
Comments The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from Cochran-Mantel-Haenszel test stratified on baseline CD4 cell count.
Method Cochran-Mantel-Haenszel
Comments No other adjustments were made.
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 6.4
Confidence Interval (2-Sided) 95%
-2.3 to 15.0
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 96
Hide Description TLOVR for participants with confirmed virologic response (2 consecutive HIV-1 RNA < 400 c/mL) prior to study drug discontinuation, was the time to the earliest of premature study regimen discontinuation, or confirmed HIV-1 RNA > 400 c/mL (2 consecutive HIV-1 RNA ≥ 400 c/mL, or the last HIV-1 RNA ≥ 400 c/mL followed by premature study regimen discontinuation due to loss to follow-up). Participants who did not achieve confirmed virologic response before premature study regimen discontinuation or last HIV-1 RNA, were assumed to have lost virologic response on Study Day 1.
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
MITT
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description:

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 244 243
Measure Type: Number
Unit of Measure: Percentage of Participants
25 37
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments Null Hypothesis: Ther percentage of participants with loss of virologic response (confirmed HIV-1 RNA < 400 c/mL) at Week 96 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA < 400 c/mL) at Week 96 for the EFV+FTC+TDF and CBV+EFV groups are different
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments The distribution of time to loss-of-virologic response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.
Method Log Rank
Comments No other adjustments were made.
14.Secondary Outcome
Title Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 96
Hide Description TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered “non-responders” on Study Day 1.
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
MITT
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description:

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 244 243
Measure Type: Number
Unit of Measure: Percentage of Participants
32 38
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments Null Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA < 50 c/mL) through Week 96 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA < 50 c/mL) through Week 96 for the EFV+FTC+TDF and CBV+EFV groups are different
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.124
Comments The distribution of time to loss-of-virologic response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.
Method Log Rank
Comments No other adjustments were made.
15.Secondary Outcome
Title Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 96
Hide Description Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
MITT
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description:

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 244 243
Measure Type: Number
Unit of Measure: Percentage of Participants
9 17
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA < 400 c/mL) at Week 96 is equal for the 2 treatment groups. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA < 400 c/mL) at Week 96 is different between the 2 treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.
Method Log Rank
Comments No other adjustments were made.
16.Secondary Outcome
Title Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 96
Hide Description Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.
Time Frame Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
MITT
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description:

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 244 243
Measure Type: Number
Unit of Measure: Percentage of Participants
20 23
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments Null Hypothesis: The percentage of participants with pure virological failure (HIV-1 RNA < 50 c/mL) through Week 96 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with pure virological failure (HIV-1 RNA < 50 c/mL) through Week 96 for the EFV+FTC+TDF and CBV+EFV groups are different
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.
Method Log Rank
Comments No other adjustments were made.
17.Secondary Outcome
Title Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 96
Hide Description Change from study baseline to Week 96 in HIV-1 RNA in log10 scale (Week 96 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale).
Time Frame Study baseline to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
AT analysis set included all participants who received at least one dose of study medication and had not committed any major protocol violation.
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description:

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 170 145
Mean (Standard Deviation)
Unit of Measure: Log10 c/mL
-3.30  (0.57) -3.25  (0.59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments Null Hypothesis: Changes from baseline through Week 96 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline through Week 96 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are different.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments The change from baseline to Week 96 in HIV-1 RNA was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference.
Method Van Elteren
Comments No other adjustments were made.
Method of Estimation Estimation Parameter stratum-weighted difference
Estimated Value -0.05
Confidence Interval 95%
-0.17 to 0.08
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 96
Hide Description Change from study baseline to Week 96 in CD4 cell count = Week 96 CD4 cell count value minus study baseline CD4 cell count value
Time Frame Baseline to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
AT analysis set included all participants who received at least one dose of study medication and had not committed any major protocol violation.
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description:

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 166 142
Mean (Standard Deviation)
Unit of Measure: CD4 Cell Count (cells/mm^3)
270  (147.5) 237  (136.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments Null Hypothesis: Changes from baseline through Week 96 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline through Week 96 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are different.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.036
Comments The change from baseline to Week 96 in CD4 cell count was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from stratum weighted Van Elteren test.
Method Van Elteren
Comments No other adjustments were made.
Method of Estimation Estimation Parameter stratum-weighted difference
Estimated Value 32.93
Confidence Interval 95%
0.87 to 64.99
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Change in Limb Fat (kg) From Week 48 to Week 96
Hide Description Change from Week 48 to Week 96 in limb fat = Week 96 limb fat value minus Week 48 limb fat value.
Time Frame Week 48 to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (whole body dual-energy X-ray absorptiometry [DEXA] scans to determine limb fat content were conducted only at selected sites at Week 48 and Week 96. ITT analysis set: 93)
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description:

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 49 44
Mean (Standard Deviation)
Unit of Measure: limb fat (kg)
0.74  (1.60) -0.77  (1.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments Null Hypothesis: Change from Week 48 to Week 96 in limb fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Change from Week 48 to Week 96 in limb fat for the EFV+FTC+TDF and CBV+EFV groups are not equal
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The change from Week 48 to Week 96 in limb fat was compared between the 2 treatment groups; the P-value is from the Wilcoxon Rank Sum Test.
Method Wilcoxon Rank Sum Test
Comments No other adjustments were made.
20.Secondary Outcome
Title Change in Trunk Fat (kg) From Week 48 to Week 96
Hide Description Change from Week 48 to Week 96 in trunk fat = Week 96 trunk fat value minus Week 48 trunk fat value
Time Frame Week 48 to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (whole body DEXA scans to determine trunk fat content were conducted only at selected sites at Week 48 and Week 96. ITT analysis set: 93)
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description:

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 49 44
Mean (Standard Deviation)
Unit of Measure: trunk fat (kg)
0.94  (2.30) -0.04  (1.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments Null Hypothesis: Changes from Week 48 to Week 96 in Trunk Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 to Week 96 in Trunk Fat for the EFV+FTC+TDF and CBV+EFV groups are different
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments The change from Week 48 to Week 96 in trunk fat was compared between the 2 treatment groups; the P-value is from the Wilcoxon Rank Sum Test.
Method Wilcoxon Rank Sum test
Comments No other adjustments were made.
21.Secondary Outcome
Title Change in Total Body Fat (kg) From Week 48 to Week 96
Hide Description Change from Week 48 to Week 96 in total body fat = Week 96 total body fat value minus Week 48 total body fat value
Time Frame 48 weeks to 96 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (whole body DEXA scans to determine total body fat content were conducted only at selected sites at Week 48 and Week 96. ITT analysis set for limb fat analyses: 93)
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description:

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 49 44
Mean (Standard Deviation)
Unit of Measure: total body fat (kg)
1.69  (3.80) -0.82  (3.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments Null Hypothesis: Changes from Week 48 to Week 96 in Total Body Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 to Week 96 in Total Body Fat for the EFV+FTC+TDF and CBV+EFV groups are different
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The change from Week 48 to Week 96 in trunk fat was compared between the 2 treatment groups; the P-value is from the Wilcoxon Rank Sum Test.
Method Wilcoxon Rank Sum test
Comments No other adjustments were made.
22.Secondary Outcome
Title Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 144 (Defined by FDA TLOVR Algorithm)
Hide Description Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug, except nevirapine in place of EFV, prior to Week 144 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 144 visit (i.e., the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 144 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV-1 RNA levels < 400 c/mL prior to Week 144 visit.
Time Frame 144 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Week 144 Efficacy Analysis set (excludes the Week 96 responders who did not consent after Week 96 visits from Week 96 efficacy analysis set [Week 144 efficacy analysis set: 456).
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description:

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 227 229
Measure Type: Number
Unit of Measure: Percentage of Participants
70.9 58.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments

Null Hypothesis: the proportion of responders (who achieved and maintained confirmed HIV-1 RNA < 400 c/mL [defined by the TLOVR algorithm]) through Week 144 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.

Alternative Hypothesis: the proportion of responders who achieved and maintained confirmed HIV-1 RNA < 400 c/mL [defined by the TLOVR algorithm]) through Week 144 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group.

Type of Statistical Test Non-Inferiority or Equivalence
Comments The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was > −0.13.
Statistical Test of Hypothesis P-Value 0.004
Comments The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from Cochran-Mantel-Haenzel test.
Method Cochran-Mantel-Haenszel
Comments No other adjustments were made.
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 12.9
Confidence Interval (2-Sided) 95%
4.2 to 21.6
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 144 (Defined by FDA TLOVR Algorithm)
Hide Description Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL (c/mL) had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug, except nevirapine in place of EFV, prior to Week 144 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 144 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 144 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV-1 RNA levels < 50 c/mL prior to Week 144 visit.
Time Frame Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
Week 144 Efficacy Analysis set (excludes the Week 96 responders who did not consent after Week 96 visits from Week 96 efficacy analysis set [Week 144 efficacy analysis set: 458).
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description:

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 227 231
Measure Type: Number
Unit of Measure: Percentage of participants
64.3 56.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments

Null Hypothesis: the proportion of responders (who achieved and maintained confirmed HIV-1 RNA < 50 c/mL [defined by the TLOVR algorithm]) through Week 144 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.

Alternative Hypothesis: the proportion of responders who achieved and maintained confirmed HIV-1 RNA < 50 c/mL [defined by the TLOVR algorithm]) through Week 144 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group.

Type of Statistical Test Non-Inferiority or Equivalence
Comments The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was > −0.13.
Statistical Test of Hypothesis P-Value 0.082
Comments The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenszel test stratified on baseline CD4 cell count.
Method Cochran-Mantel-Haenszel
Comments No other adjustments were made.
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 8.1
Confidence Interval (2-Sided) 95%
-0.8 to 17.0
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 144
Hide Description The percentage of participants with plasma HIV-1 RNA < 400 c/mL at Week 144. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis).
Time Frame Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis set
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description:

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 255 254
Measure Type: Number
Unit of Measure: Percentage of Participants
63.1 51.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments Null Hypothesis: The percentage of participants with HIV-1 RNA < 400 c/mL at Week 144 in the EFV+FTC+TDF group is more than 13% worse than the CBV+EFV group. Alternative hypothesis: The percentage of participants with HIV-1 RNA < 400 c/mL at Week 144 in the EFV+FTC+TDF group is no more than 13% worse than the CBV+EFV group.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was > −0.13.
Statistical Test of Hypothesis P-Value 0.009
Comments The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.
Method Cochran-Mantel-Haenszel
Comments No other adjustments were made.
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 11.6
Confidence Interval 95%
3.1 to 20.1
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 144
Hide Description The percentage of participants with plasma HIV-1 RNA < 50 c/mL at Week 144. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis).
Time Frame Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis set (Missing Observation or Switch in ART=Failure)
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description:

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 255 254
Measure Type: Number
Unit of Measure: Percentage of Participants
60.8 50.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments Null hypothesis: The percentage of participants with HIV-1 RNA < 50 c/mL at Week 144 in the EFV+FTC+TDF group is more than 13% worse than the CBV+EFV group. Alternative hypothesis: The percentage of participants with HIV-1 RNA < 50 c/mL at Week 144 in the EFV+FTC+TDF group is no more than 13% worse than the CBV+EFV group.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was > −0.13.
Statistical Test of Hypothesis P-Value 0.019
Comments The p-value for the superiority test is from Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.
Method Cochran-Mantel-Haenszel
Comments No other adjustments were made.
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 10.4
Confidence Interval (2-Sided) 95%
1.8 to 19.0
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 144
Hide Description TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered “non-responders” on Study Day 1.
Time Frame Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
MITT
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description:

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 244 243
Measure Type: Number
Unit of Measure: Percentage of Participants
28 41
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments Null Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA < 400 c/mL) through Week 144 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA < 400 c/mL) through Week 144 for the EFV+FTC+TDF and CBV+EFV groups are different
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments The distribution of loss of virological response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.
Method Log Rank
Comments No other adjustments were made.
27.Secondary Outcome
Title Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 144
Hide Description TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered “non-responders” on Study Day 1.
Time Frame Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
MITT
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description:

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 244 243
Measure Type: Number
Unit of Measure: Percentage of Participants
34 43
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments Null Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA < 50 c/mL) through Week 144 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA < 50 c/mL) through Week 144 for the EFV+FTC+TDF and CBV+EFV groups are different
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.056
Comments The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.
Method Log Rank
Comments No other adjustments were made.
28.Secondary Outcome
Title Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) at Week 144
Hide Description Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.
Time Frame Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
MITT
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description:

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 244 243
Measure Type: Number
Unit of Measure: Percentage of participants
11 17
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA < 400 c/mL) at Week 144 is equal for the 2 treatment groups. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA < 400 c/mL) at Week 144 is different between the 2 treatment groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.066
Comments The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.
Method Log Rank
Comments No other adjustments were made.
29.Secondary Outcome
Title Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) at Week 144
Hide Description Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.
Time Frame Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
MITT
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description:

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 244 243
Measure Type: Number
Unit of Measure: Percentage of Participants
21 25
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA < 50 c/mL) at Week 144 is equal for the 2 treatment groups. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA < 50 c/mL) at Week 144 is different between the 2 treatment groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.30
Comments The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.
Method Log Rank
Comments No other adjustments were made.
30.Secondary Outcome
Title Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 144
Hide Description Change from study baseline to Week 144 in HIV-1 RNA in log10 scale (Week 144 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale).
Time Frame Study baseline to Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
AT analysis set
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description:

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 160 124
Mean (Standard Deviation)
Unit of Measure: Log10 c/mL
-3.32  (0.54) -3.30  (0.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments Null Hypothesis: Changes from baseline to Week 144 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline to Week 144 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are different.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments The change from baseline to Week 144 in HIV-1 RNA was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from a stratum weighted Van Elteren test.
Method Van Elteren
Comments No other adjustments were made
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-0.16 to 0.08
Estimation Comments [Not Specified]
31.Secondary Outcome
Title Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 144
Hide Description Change from study baseline to Week 144 in CD4 cell count = Week 144 CD4 cell count value minus study baseline CD4 cell count value
Time Frame Baseline to Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
AT analysis set
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description:

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 152 122
Mean (Standard Deviation)
Unit of Measure: CD4 Cell Count (cells/mm^3)
312  (161.2) 271  (147.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments Null Hypothesis: Changes from baseline toWeek 144 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline to Week 144 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are different.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.089
Comments The change from baseline to Week 144 in CD4 cell count was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from a stratum weighted Van Elteren test.
Method Van Elteren
Comments No other adjustments were made
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 41.30
Confidence Interval (2-Sided) 95%
4.05 to 78.55
Estimation Comments [Not Specified]
32.Secondary Outcome
Title Change in Limb Fat (kg) From Week 48 to Week 144
Hide Description Change from Week 48 to Week 144 in limb fat = Week 144 limb fat value minus Week 48 limb fat value
Time Frame Week 48 to Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (whole body DEXA scans to determine limb fat content were conducted only at selected sites at Week 48, Week 96 and Week 144. ITT analysis set: 86)
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description:

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 48 38
Mean (Standard Deviation)
Unit of Measure: limb fat (kg)
1.13  (1.93) -1.09  (1.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments Null Hypothesis: Changes from Week 48 baseline to Week 144 in Limb Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 baseline to Week 144 in Limb Fat for the EFV+FTC+TDF and CBV+EFV groups are different
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments P-value is from the Wilcoxon Rank Sum Test
Method Wilcoxon Rank Sum test
Comments No other adjustments were made
33.Secondary Outcome
Title Change in Trunk Fat (kg) From Week 48 to Week 144
Hide Description Change from Week 48 to Week 144 in trunk fat = Week 144 trunk fat value minus Week 48 trunk fat value
Time Frame Week 48 to Week 144
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (whole body DEXA scans to determine trunk fat content were conducted only at selected sites at Week 48, Week 96 and Week 144. ITT analysis set: 86)
Arm/Group Title EFV+FTC+TDF CBV+EFV
Hide Arm/Group Description:

Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 48 38
Mean (Standard Deviation)
Unit of Measure: trunk fat (kg)
1.30  (2.40) -0.10  (1.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments Null Hypothesis: Changes from Week 48 baseline to Week 144 in Trunk Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 baseline to Week 144 in Trunk Fat for the EFV+FTC+TDF and CBV+EFV groups are different
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments P-value is from the Wilcoxon Rank Sum Test
Method Wilcoxon Rank Sum test
Comments No other adjustments were made
34.Secondary Outcome
Title Change in Total Body Fat (kg) From Week 48 to Week 144
Hide Description Change from Week 48 to Week 144 in total body fat = Week 144 total body fat value minus Week 48 total body fat value
Time Frame Week 48 to Week 144
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ITT (whole body DEXA scans to determine total body fat content were conducted only at selected sites at Week 48, Week 96 and Week 144. ITT analysis set: 86)
Arm/Group Title EFV+FTC+TDF CBV+EFV
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Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.

At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.

At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.

Overall Number of Participants Analyzed 48 38
Mean (Standard Deviation)
Unit of Measure: total body fat (kg)
2.47  (4.22) -1.18  (3.37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection EFV+FTC+TDF, CBV+EFV
Comments Null Hypothesis: Changes from Week 48 baseline to Week 144 in Total Body Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 baseline to Week 144 in Total Body Fat for the EFV+FTC+TDF and CBV+EFV groups are different
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is from the Wilcoxon Rank Sum Test
Method Wilcoxon Rank Sum test
Comments No other adjustments were made
35.Secondary Outcome
Title Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm
Hide Description Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 240 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 240 visit (that is, the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 240 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV RNA levels < 400 c/mL prior to Week 240 visit.
Time Frame Week 144 (Atripla baseline) to Week 240 (Atripla Week 96)
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Atripla Efficacy Analysis Set (all participants who received at least one dose of Atripla). Data collected after permanent discontinuation of the study regimen was excluded from this analysis set.
Arm/Group Title All Atripla
Hide Arm/Group Description:
Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Overall Number of Participants Analyzed 286
Measure Type: Number
Unit of Measure: Percentage of Participants
87
36.Secondary Outcome
Title Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm
Hide Description Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 240 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 240 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 240 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV RNA levels < 50 c/mL prior to Week 240 visit.
Time Frame Week 144 (Atripla baseline) to Week 240 (Atripla Week 96)
Hide Outcome Measure Data
Hide Analysis Population Description
Atripla Efficacy Analysis Set
Arm/Group Title All Atripla
Hide Arm/Group Description:
Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Overall Number of Participants Analyzed 286
Measure Type: Number
Unit of Measure: Percentage of Participants
85
37.Secondary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96)
Hide Description The percentage of participants with plasma HIV-1 RNA < 400 c/mL at Week 240. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis).
Time Frame Week 240 (Atripla Week 96)
Hide Outcome Measure Data
Hide Analysis Population Description
Atripla Efficacy Analysis Set
Arm/Group Title EFV+FTC+TDF/Atripla (From Study Baseline) All Atripla (From Atripla Baseline)
Hide Arm/Group Description:
Participants in this group were originally randomized to receive the 3 component drugs: efavirenz (EFV) + emtricitabine (FTC) + tenofovir disoproxil fumarate (tenofovir DF; TDF) for 96 weeks, and subsequently received Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF) and EFV until Week 144. Participants then rolled over into the further 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Overall Number of Participants Analyzed 160 286
Measure Type: Number
Unit of Measure: Percentage of Participants
87 85
38.Secondary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96)
Hide Description The percentage of participants with plasma HIV-1 RNA < 50 c/mL at Week 240. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis).
Time Frame Week 240 (Atripla Week 96)
Hide Outcome Measure Data
Hide Analysis Population Description
Atripla Efficacy Analysis Set
Arm/Group Title EFV+FTC+TDF/Atripla (From Study Baseline) All Atripla (From Atripla Baseline)
Hide Arm/Group Description:
Participants in this group were originally randomized to receive the 3 component drugs: efavirenz (EFV) + emtricitabine (FTC) + tenofovir disoproxil fumarate (tenofovir DF; TDF) for 96 weeks, and subsequently received Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF) and EFV until Week 144. Participants then rolled over into the further 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Overall Number of Participants Analyzed 160 286
Measure Type: Number
Unit of Measure: Percentage of Participants
84 82
39.Secondary Outcome
Title Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96)
Hide Description TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered “non-responders” on Study Day 1.
Time Frame Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Hide Outcome Measure Data
Hide Analysis Population Description
Atripla Efficacy Analysis Set
Arm/Group Title All Atripla
Hide Arm/Group Description:
Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Overall Number of Participants Analyzed 286
Measure Type: Number
Unit of Measure: Percentage of Participants
13
40.Secondary Outcome
Title Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96)
Hide Description TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered “non-responders” on Study Day 1.
Time Frame Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Hide Outcome Measure Data
Hide Analysis Population Description
Atripla Efficacy Analysis Set
Arm/Group Title All Atripla
Hide Arm/Group Description:
Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Overall Number of Participants Analyzed 286
Measure Type: Number
Unit of Measure: Percentage of Participants
15
41.Secondary Outcome
Title Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) Through Week 240 (Atripla Week 96)
Hide Description Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.
Time Frame Week 240 (Atripla Week 96)
Hide Outcome Measure Data
Hide Analysis Population Description

MITT Analysis Set (EFV+FTC+TDF group from study baseline; N=244).

Atripla Efficacy Analysis Set (All Atripla Group from Atripla baseline; N=286)

Arm/Group Title EFV+FTC+TDF/Atripla (From Study Baseline) All Atripla (From Atripla Baseline)
Hide Arm/Group Description:
Participants in this group were originally randomized to receive the 3 component drugs: efavirenz (EFV) + emtricitabine (FTC) + tenofovir disoproxil fumarate (tenofovir DF; TDF) for 96 weeks, and subsequently received Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF) and EFV until Week 144. Participants then rolled over into the further 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Overall Number of Participants Analyzed 244 286
Measure Type: Number
Unit of Measure: Percentage of Participants
11 2
42.Secondary Outcome
Title Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) Through Week 240 (Atripla Week 96)
Hide Description Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date.
Time Frame Week 240 (Atripla Week 96)
Hide Outcome Measure Data
Hide Analysis Population Description

MITT Analysis Set (EFV+FTC+TDF group from study baseline; N=244).

Atripla Efficacy Analysis Set (All Atripla Group from Atripla baseline; N=286)

Arm/Group Title EFV+FTC+TDF/Atripla (From Study Baseline) All Atripla (From Atripla Baseline)
Hide Arm/Group Description:
Participants in this group were originally randomized to receive the 3 component drugs: efavirenz (EFV) + emtricitabine (FTC) + tenofovir disoproxil fumarate (tenofovir DF; TDF) for 96 weeks, and subsequently received Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF) and EFV until Week 144. Participants then rolled over into the further 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Overall Number of Participants Analyzed 244 286
Measure Type: Number
Unit of Measure: Percentage of Participants
22 4
43.Secondary Outcome
Title Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 240 (Atripla Week 96)
Hide Description Change from baseline to Week 240 (Atripla Week 96) in CD4 cell count = Week 240 (Atripla Week 96) CD4 cell count value minus baseline CD4 cell count value
Time Frame Study/Atripla baseline to Week 240 (Atripla Week 96)
Hide Outcome Measure Data
Hide Analysis Population Description
Atripla Efficacy Analysis Set
Arm/Group Title EFV+FTC+TDF/Atripla (From Study Baseline) All Atripla (From Atripla Baseline)
Hide Arm/Group Description:
Participants in this group were originally randomized to receive the 3 component drugs: efavirenz (EFV) + emtricitabine (FTC) + tenofovir disoproxil fumarate (tenofovir DF; TDF) for 96 weeks, and subsequently received Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF) and EFV until Week 144. Participants then rolled over into the further 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Overall Number of Participants Analyzed 138 243
Mean (Standard Deviation)
Unit of Measure: CD4 Cell count (Cells/mm^3)
346  (197.2) 42  (148.2)
44.Secondary Outcome
Title Change in Limb Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Hide Description Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in limb fat = Week 240 (Atripla Week 96) limb fat value minus Week 144 (Atripla Baseline) limb fat value
Time Frame Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Hide Outcome Measure Data
Hide Analysis Population Description
Atripla Efficacy Analysis Set
Arm/Group Title All Atripla
Hide Arm/Group Description:
Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Overall Number of Participants Analyzed 213
Mean (Standard Deviation)
Unit of Measure: limb fat (kg)
0.12  (1.657)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Atripla
Comments Null Hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) limb fat value is equal to zero. Alternative hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) limb fat value is not equal to zero.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments P-value is from the Wilcoxon Signed Rank test. No adjustments for multiple comparisons were made
Method Wilcoxon Signed Rank test
Comments [Not Specified]
45.Secondary Outcome
Title Change in Trunk Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Hide Description Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in trunk fat = Week 240 (Atripla Week 96) trunk fat value minus Week 144 (Atripla Baseline) trunk fat value
Time Frame Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Hide Outcome Measure Data
Hide Analysis Population Description
Atripla Efficacy Analysis Set
Arm/Group Title All Atripla
Hide Arm/Group Description:
Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Overall Number of Participants Analyzed 213
Mean (Standard Deviation)
Unit of Measure: trunk fat (kg)
0.27  (2.242)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Atripla
Comments Null Hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) trunk fat value is equal to zero. Alternative hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) trunk fat value is not equal to zero.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.049
Comments P-value is from the Wilcoxon Signed Rank test. No adjustments for multiple comparisons were made
Method Wilcoxon Signed Rank test
Comments [Not Specified]
46.Secondary Outcome
Title Change in Total Body Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Hide Description Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in total body fat = Week 240 (Atripla Week 96) total body fat value minus Week 144 (Atripla Baseline) total body fat value
Time Frame Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Hide Outcome Measure Data
Hide Analysis Population Description
Atripla Efficacy Analysis Set
Arm/Group Title All Atripla
Hide Arm/Group Description:
Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Overall Number of Participants Analyzed 212
Mean (Standard Deviation)
Unit of Measure: total body fat (kg)
0.37  (3.747)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Atripla
Comments Null Hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) total body fat value is equal to zero. Alternative hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) total body fat value is not equal to zero.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.055
Comments P-value is from the Wilcoxon Signed Rank test. No adjustments for multiple comparisons were made
Method Wilcoxon Signed Rank test
Comments [Not Specified]
47.Secondary Outcome
Title Treatment Satisfaction Questionnaire (Satisfaction With Convenience and Simplicity of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.
Hide Description Participants were asked: "In general, how satisfied are you with the convenience and simplicity of your current treatment regimen?" Possible responses were on a 4-category scale: "very satisfied"; "somewhat satisfied"; "somewhat dissatisfied"; and "very dissatisfied". For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into "very satisfied" and "not very satisfied" ("not very satisfied" included "very dissatisfied"; "somewhat dissatisfied"; and "somewhat satisfied").
Time Frame Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)
Hide Outcome Measure Data
Hide Analysis Population Description
Atripla Efficacy Analysis Set
Arm/Group Title All Atripla
Hide Arm/Group Description:
Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Overall Number of Participants Analyzed 225
Measure Type: Number
Unit of Measure: Participants
Very satisfied (W 144 and W 240) 182
Not very satisfied (W 144 and W 240) 6
Very satisfied (W 144); not very satisfied (W 240) 8
Not very satisfied (W 144); very satisfied (W 240) 29
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Atripla
Comments Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The number and proportion of participants in each category ("very satisfied", "not very satisfied") were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test.
Method McNemar
Comments [Not Specified]
48.Secondary Outcome
Title Treatment Satisfaction Questionnaire (Satisfaction With Current Treatment Regimen to Control HIV): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.
Hide Description Participants were asked: "In general, how satisfied are you with the ability of your current treatment regimen to control your HIV infection?" Possible responses were on a 4-category scale: "very satisfied"; "somewhat satisfied"; "somewhat dissatisfied"; and "very dissatisfied". For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into "very satisfied" and "not very satisfied" ("not very satisfied" included "very dissatisfied"; "somewhat dissatisfied"; and "somewhat satisfied").
Time Frame Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)
Hide Outcome Measure Data
Hide Analysis Population Description
Atripla Efficacy Analysis Set
Arm/Group Title All Atripla
Hide Arm/Group Description:
Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Overall Number of Participants Analyzed 226
Measure Type: Number
Unit of Measure: Participants
Very satisfied (W 144 and W 240) 192
Not very satisfied (W 144 and W 240) 8
Very satisfied (W 144); not very satisfied (W 240) 9
Not very satisfied (W 144); very satisfied (W 240) 17
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Atripla
Comments Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments The number and proportion of participants in each category ("very satisfied", "not very satisfied") were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test.
Method McNemar
Comments [Not Specified]
49.Secondary Outcome
Title Treatment Satisfaction Questionnaire (Satisfaction With Tolerability of Current Treatment Regimen) Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.
Hide Description Participants were asked: "In general, how satisfied are you with your ability to tolerate your current treatment regimen?" Possible responses were on a 4-category scale: "very satisfied"; "somewhat satisfied"; "somewhat dissatisfied"; and "very dissatisfied". For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into "very satisfied" and "not very satisfied" ("not very satisfied" included "very dissatisfied"; "somewhat dissatisfied"; and "somewhat satisfied").
Time Frame Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)
Hide Outcome Measure Data
Hide Analysis Population Description
Atripla Efficacy Analysis Set
Arm/Group Title All Atripla
Hide Arm/Group Description:
Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Overall Number of Participants Analyzed 226
Measure Type: Number
Unit of Measure: Participants
Very satisfied (W 144 and W 240) 166
Not very satisfied (W 144 and W 240) 21
Very satisfied (W 144); not very satisfied (W 240) 13
Not very satisfied (W 144); very satisfied (W 240) 26
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Atripla
Comments Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.037
Comments The number and proportion of participants in each category ("very satisfied", "not very satisfied") were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test.
Method McNemar
Comments [Not Specified]
50.Secondary Outcome
Title Treatment Satisfaction Questionnaire (General Satisfaction With Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.
Hide Description Participants were asked: "In general, how satisfied are you with your current treatment regimen?" Possible responses were on a 4-category scale: "very satisfied"; "somewhat satisfied"; "somewhat dissatisfied"; and "very dissatisfied". For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into "very satisfied" and "not very satisfied" ("not very satisfied" included "very dissatisfied"; "somewhat dissatisfied"; and "somewhat satisfied").
Time Frame Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)
Hide Outcome Measure Data
Hide Analysis Population Description
Atripla Efficacy Analysis Set
Arm/Group Title All Atripla
Hide Arm/Group Description:
Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Overall Number of Participants Analyzed 222
Measure Type: Number
Unit of Measure: Participants
Very satisfied (W 144 and W 240) 180
Not very satisfied (W 144 and W 240) 10
Very satisfied (W 144); not very satisfied (W 240) 9
Not very satisfied (W 144); very satisfied (W 240) 23
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Atripla
Comments Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments The number and proportion of participants in each category ("very satisfied", "not very satisfied") were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test.
Method McNemar
Comments [Not Specified]
51.Secondary Outcome
Title Treatment Satisfaction Questionnaire (Bothered With the Side Effects of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.
Hide Description Participants were asked: "How bothered are you with the side effects of your current treatment regimen?" Possible responses were on a 4-category scale: "does not bother me"; "bothers me a little bit"; "bothers me a lot"; and "bothers me terribly". For the evaluation of the change in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into "does not bother me" and "bothers me" ("bothers me" included "bothers me a little bit"; "bothers me a lot"; "bothers me terribly").
Time Frame Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)
Hide Outcome Measure Data
Hide Analysis Population Description
Atripla Efficacy Analysis Set
Arm/Group Title All Atripla
Hide Arm/Group Description:
Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Overall Number of Participants Analyzed 226
Measure Type: Number
Unit of Measure: Participants
Bothers me (W 144 and W 240) 41
Does not bother me (W 144 and W 240) 126
Bothers me (W 144); does not bother me (W 240) 31
Does not bother me (W 144); bothers me (W 240) 28
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Atripla
Comments Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments The number and proportion of participants in each category ("bothers", "does not bother") were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test.
Method McNemar
Comments [Not Specified]
52.Secondary Outcome
Title Quality of Life (SF-12v2 Health Survey: Physical Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Hide Description The change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) in the SF-12v2 Health Survey: Physical Component Summary (PCS). The SF-12v2 includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of 2 composite scores: the PCS and the Mental Component Summary (MCS). PCS and MCS values can range from 0 to 100 and are designed to have a mean value of 50 and SD of 10 (in the general population).
Time Frame Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Hide Outcome Measure Data
Hide Analysis Population Description
Atripla Efficacy Analysis Set
Arm/Group Title All Atripla
Hide Arm/Group Description:
Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Overall Number of Participants Analyzed 213
Mean (Standard Deviation)
Unit of Measure: Composite Score
0.0  (6.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Atripla
Comments Null Hypothesis: There is no change in the PCS score from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a change in the PCS score from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments P-value is from the Wilcoxon Signed Rank Test.
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
53.Secondary Outcome
Title Quality of Life (SF-12v2 Health Survey: Mental Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Hide Description The change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) in the SF-12v2 Health Survey MCS. The SF-12v2 includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of 2 composite scores: the PCS and the MCS. PCS and MCS values can range from 0 to 100 and are designed to have a mean value of 50 and a SD of 10 (in the general population).
Time Frame Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Hide Outcome Measure Data
Hide Analysis Population Description
Atripla Efficacy Analysis Set
Arm/Group Title All Atripla
Hide Arm/Group Description:
Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
Overall Number of Participants Analyzed 213
Mean (Standard Deviation)
Unit of Measure: Composite Score
0.9  (8.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Atripla
Comments Null Hypothesis: There is no change in the MCS score from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a change in the MCS score from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments P-value is from the Wilcoxon Signed Rank Test
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Time Frame Adverse events (AEs) were reported during the 144-week randomized treatment phase (FTC+TDF+EFV and CBV+EFV groups) and for the 96-week non-randomized Atripla extension phase (for all participants who opted to switch to Atripla).
Adverse Event Reporting Description AEs are reported for the FTC+TDF+EFV and CBV+EFV groups from baseline through to Week 144 and for all participants who opted to receive ATR from Week 144 to 240 (All Atripla group). AEs are also reported for those participants who received FTC+TDF+EFV from baseline until Week 144 and opted to receive ATR until Week 240/288 (FTC+TDF+EFV/ATR group).
 
Arm/Group Title FTC+TDF+EFV (Baseline to 144 Weeks) FTC+TDF+EFV/ATR (Baseline to 240 Weeks) CBV+EFV (Baseline to 144 Weeks) All Atripla (Week 144 to 240)
Hide Arm/Group Description Exposure to the component drugs EFV+FTC+TDF during the randomized treatment phase was up to 144 weeks (TVD replaced FTC+TDF from Week 96). For this safety population, N=257. Exposure to the component drugs EFV+FTC+TDF during the randomized treatment phase and during the Atripla treatment phase was up to 240 weeks (TVD replaced FTC+TDF at Week 96; ATR replaced TVD+EFV at Week 144). Exposure to ATR for 6 participants at sites in France was up to 288 weeks (this was due to a protocol amendment which allowed these participants to continue to receive ATR until it became commercially available). For this safety population, N=160. Exposure to CBV+EFV during the randomized treatment phase was up to 144 weeks. For this safety population, N=254. Exposure for all participants from both treatment groups who switched to ATR at Week 144 and continued treatment to Week 240 was up to 96 weeks. Exposure to ATR for 6 participants at sites in France was up to 144 weeks (this was due to a protocol amendment which allowed these participants to continue to receive ATR until it became commercially available). For this safety population, N=286.
All-Cause Mortality
FTC+TDF+EFV (Baseline to 144 Weeks) FTC+TDF+EFV/ATR (Baseline to 240 Weeks) CBV+EFV (Baseline to 144 Weeks) All Atripla (Week 144 to 240)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
FTC+TDF+EFV (Baseline to 144 Weeks) FTC+TDF+EFV/ATR (Baseline to 240 Weeks) CBV+EFV (Baseline to 144 Weeks) All Atripla (Week 144 to 240)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   29/257 (11.28%)   24/160 (15.00%)   35/254 (13.78%)   14/286 (4.90%) 
Blood and lymphatic system disorders         
Anaemia  1  0/257 (0.00%)  0/160 (0.00%)  7/254 (2.76%)  0/286 (0.00%) 
Cardiac disorders         
Acute Myocardial Infarction  1  1/257 (0.39%)  0/160 (0.00%)  0/254 (0.00%)  1/286 (0.35%) 
Cardiac Disorder  2  0/257 (0.00%)  0/160 (0.00%)  0/254 (0.00%)  1/286 (0.35%) 
Nodal Rhythm  1  1/257 (0.39%)  1/160 (0.63%)  0/254 (0.00%)  0/286 (0.00%) 
Tachyarrhythmia  2  0/257 (0.00%)  0/160 (0.00%)  0/254 (0.00%)  1/286 (0.35%) 
Endocrine disorders         
Basedow's Disease  1  1/257 (0.39%)  0/160 (0.00%)  0/254 (0.00%)  0/286 (0.00%) 
Gastrointestinal disorders         
Abdominal Pain  1  1/257 (0.39%)  0/160 (0.00%)  0/254 (0.00%)  0/286 (0.00%) 
Dental Caries  1  1/257 (0.39%)  1/160 (0.63%)  0/254 (0.00%)  0/286 (0.00%) 
Gastritis  1  0/257 (0.00%)  0/160 (0.00%)  1/254 (0.39%)  0/286 (0.00%) 
Pancreatitis  1  1/257 (0.39%)  0/160 (0.00%)  0/254 (0.00%)  0/286 (0.00%) 
Pancreatitis Acute  1  0/257 (0.00%)  0/160 (0.00%)  1/254 (0.39%)  0/286 (0.00%) 
General disorders         
Chest pain  1  0/257 (0.00%)  0/160 (0.00%)  1/254 (0.39%)  0/286 (0.00%) 
Immune system disorders         
Immune Reconstitution Syndrome  1  0/257 (0.00%)  0/160 (0.00%)  1/254 (0.39%)  0/286 (0.00%) 
Infections and infestations         
Appendicitis  1  2/257 (0.78%)  2/160 (1.25%)  2/254 (0.79%)  0/286 (0.00%) 
Catheter Sepsis  1  0/257 (0.00%)  0/160 (0.00%)  1/254 (0.39%)  0/286 (0.00%) 
Cellulitis  1  0/257 (0.00%)  0/160 (0.00%)  1/254 (0.39%)  0/286 (0.00%) 
Cellulitis Staphylococcus  1  0/257 (0.00%)  0/160 (0.00%)  1/254 (0.39%)  0/286 (0.00%) 
Enterocolitis Infectious  1  0/257 (0.00%)  0/160 (0.00%)  1/254 (0.39%)  0/286 (0.00%) 
Escherichia Bacteriemia  1  0/257 (0.00%)  0/160 (0.00%)  1/254 (0.39%)  0/286 (0.00%) 
Furuncle  1  0/257 (0.00%)  0/160 (0.00%)  1/254 (0.39%)  0/286 (0.00%) 
Gastroenteritis Cryptosporidial  1  1/257 (0.39%)  1/160 (0.63%)  0/254 (0.00%)  0/286 (0.00%) 
Gastroenteritis Salmonella  2  0/257 (0.00%)  1/160 (0.63%)  0/254 (0.00%)  1/286 (0.35%) 
Hepatitis C  2  0/257 (0.00%)  1/160 (0.63%)  0/254 (0.00%)  1/286 (0.35%) 
Lobar Pneumonia  1  1/257 (0.39%)  1/160 (0.63%)  0/254 (0.00%)  0/286 (0.00%) 
Lower Respiratory Tract Infection  1  0/257 (0.00%)  0/160 (0.00%)  1/254 (0.39%)  0/286 (0.00%) 
Mastoiditis  1  1/257 (0.39%)  0/160 (0.00%)  0/254 (0.00%)  0/286 (0.00%) 
Meningitis Cryptococcal  1  1/257 (0.39%)  0/160 (0.00%)  1/254 (0.39%)  0/286 (0.00%) 
Meningitis Viral  1  0/257 (0.00%)  0/160 (0.00%)  1/254 (0.39%)  0/286 (0.00%) 
Mycobacterium Avium Complex Infection  1  0/257 (0.00%)  0/160 (0.00%)  1/254 (0.39%)  0/286 (0.00%) 
Mycobacterium Kansasii Infection  1  1/257 (0.39%)  0/160 (0.00%)  0/254 (0.00%)  0/286 (0.00%) 
Perirectal abscess  1  1/257 (0.39%)  1/160 (0.63%)  0/254 (0.00%)  0/286 (0.00%) 
Pneumonia  1  2/257 (0.78%)  3/160 (1.88%)  2/254 (0.79%)  1/286 (0.35%) 
Progressive Multifocal Leukoencephalopathy  1  0/257 (0.00%)  0/160 (0.00%)  1/254 (0.39%)  0/286 (0.00%) 
Rectal Abscess  1  0/257 (0.00%)  0/160 (0.00%)  1/254 (0.39%)  0/286 (0.00%) 
Secondary Syphilis  2  0/257 (0.00%)  1/160 (0.63%)  0/254 (0.00%)  1/286 (0.35%) 
Sepsis  1  1/257 (0.39%)  0/160 (0.00%)  0/254 (0.00%)  0/286 (0.00%) 
Staphylococcal Abscess  1  0/257 (0.00%)  0/160 (0.00%)  2/254 (0.79%)  0/286 (0.00%) 
Subcutaneous Abscess  2  0/257 (0.00%)  2/160 (1.25%)  0/254 (0.00%)  2/286 (0.70%) 
Tonsillitis Streptococcal  1  1/257 (0.39%)  1/160 (0.63%)  0/254 (0.00%)  0/286 (0.00%) 
Upper Respiratory Tract Infection  2  0/257 (0.00%)  1/160 (0.63%)  0/254 (0.00%)  1/286 (0.35%) 
Injury, poisoning and procedural complications         
Femoral Neck Fracture  1  1/257 (0.39%)  0/160 (0.00%)  0/254 (0.00%)  0/286 (0.00%) 
Incisional Hernia  1  0/257 (0.00%)  0/160 (0.00%)  1/254 (0.39%)  0/286 (0.00%) 
Intentional Overdose  1  1/257 (0.39%)  1/160 (0.63%)  0/254 (0.00%)  0/286 (0.00%) 
Lower Limb Fracture  1  0/257 (0.00%)  0/160 (0.00%)  1/254 (0.39%)  0/286 (0.00%) 
Traumatic Brain Injury  1  0/257 (0.00%)  0/160 (0.00%)  1/254 (0.39%)  0/286 (0.00%) 
Vascular Graft Occlusion  1  0/257 (0.00%)  0/160 (0.00%)  1/254 (0.39%)  0/286 (0.00%) 
Metabolism and nutrition disorders         
Hypercreatinaemia  1  0/257 (0.00%)  0/160 (0.00%)  1/254 (0.39%)  0/286 (0.00%) 
Hypoglycemia  1  0/257 (0.00%)  0/160 (0.00%)  1/254 (0.39%)  0/286 (0.00%) 
Musculoskeletal and connective tissue disorders         
Osteonecrosis  2  0/257 (0.00%)  1/160 (0.63%)  0/254 (0.00%)  1/286 (0.35%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Anal Cancer Metastatic  2  0/257 (0.00%)  1/160 (0.63%)  0/254 (0.00%)  1/286 (0.35%) 
Cervix Carcinoma Stage 0  1  1/257 (0.39%)  0/160 (0.00%)  0/254 (0.00%)  0/286 (0.00%) 
Kaposi's Sarcoma  1  1/257 (0.39%)  0/160 (0.00%)  0/254 (0.00%)  0/286 (0.00%) 
Lung Adenocarcinoma  1  1/257 (0.39%)  0/160 (0.00%)  0/254 (0.00%)  0/286 (0.00%) 
Metastatic Neoplasm  1  0/257 (0.00%)  0/160 (0.00%)  1/254 (0.39%)  0/286 (0.00%) 
Non-Hodgkin's Lymphoma  1  1/257 (0.39%)  0/160 (0.00%)  0/254 (0.00%)  0/286 (0.00%) 
Uterine Leiomyoma  1  0/257 (0.00%)  0/160 (0.00%)  1/254 (0.39%)  0/286 (0.00%) 
Nervous system disorders         
Carpal Tunnel Syndrome  1  0/257 (0.00%)  0/160 (0.00%)  1/254 (0.39%)  0/286 (0.00%) 
Cerebrovascular Accident  1  0/257 (0.00%)  0/160 (0.00%)  1/254 (0.39%)  1/286 (0.35%) 
Cervicobrachial Syndrome  1  0/257 (0.00%)  0/160 (0.00%)  1/254 (0.39%)  0/286 (0.00%) 
Convulsion  1  0/257 (0.00%)  0/160 (0.00%)  1/254 (0.39%)  0/286 (0.00%) 
Meningorrhagia  1  1/257 (0.39%)  1/160 (0.63%)  0/254 (0.00%)  0/286 (0.00%) 
Syncope  1  0/257 (0.00%)  0/160 (0.00%)  1/254 (0.39%)  0/286 (0.00%) 
Transient Ischemic Attack  1  1/257 (0.39%)  1/160 (0.63%)  0/254 (0.00%)  0/286 (0.00%) 
Pregnancy, puerperium and perinatal conditions         
Ectopic Pregnancy  1  1/257 (0.39%)  0/160 (0.00%)  0/254 (0.00%)  0/286 (0.00%) 
Psychiatric disorders         
Alcoholism  1  1/257 (0.39%)  1/160 (0.63%)  0/254 (0.00%)  0/286 (0.00%) 
Completed Suicide  2  0/257 (0.00%)  0/160 (0.00%)  0/254 (0.00%)  1/286 (0.35%) 
Depression  1  0/257 (0.00%)  0/160 (0.00%)  1/254 (0.39%)  0/286 (0.00%) 
Psychotic Disorder  1  0/257 (0.00%)  0/160 (0.00%)  1/254 (0.39%)  0/286 (0.00%) 
Suicidal Ideation  1  0/257 (0.00%)  0/160 (0.00%)  1/254 (0.39%)  0/286 (0.00%) 
Renal and urinary disorders         
Nephrolithiasis  1  2/257 (0.78%)  2/160 (1.25%)  0/254 (0.00%)  0/286 (0.00%) 
Ureteric Obstruction  1  1/257 (0.39%)  1/160 (0.63%)  0/254 (0.00%)  0/286 (0.00%) 
Reproductive system and breast disorders         
Benign Prostatic Hyperplasia  2  0/257 (0.00%)  1/160 (0.63%)  0/254 (0.00%)  1/286 (0.35%) 
Respiratory, thoracic and mediastinal disorders         
Acute Pulmonary Edema  1  0/257 (0.00%)  0/160 (0.00%)  1/254 (0.39%)  0/286 (0.00%) 
Hiccups  1  1/257 (0.39%)  0/160 (0.00%)  0/254 (0.00%)  0/286 (0.00%) 
Skin and subcutaneous tissue disorders         
Drug Eruption  1  1/257 (0.39%)  0/160 (0.00%)  0/254 (0.00%)  0/286 (0.00%) 
Neurodermatitis  1  1/257 (0.39%)  1/160 (0.63%)  0/254 (0.00%)  0/286 (0.00%) 
Surgical and medical procedures         
Cholecystectomy  1  1/257 (0.39%)  0/160 (0.00%)  0/254 (0.00%)  0/286 (0.00%) 
Splenectomy  1  1/257 (0.39%)  0/160 (0.00%)  0/254 (0.00%)  0/286 (0.00%) 
Vascular disorders         
Hypertensive Crisis  1  1/257 (0.39%)  0/160 (0.00%)  0/254 (0.00%)  0/286 (0.00%) 
Peripheral Ischemia  1  0/257 (0.00%)  0/160 (0.00%)  1/254 (0.39%)  0/286 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.1)
2
Term from vocabulary, MedDRA (11.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FTC+TDF+EFV (Baseline to 144 Weeks)