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Efavirenz or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir Disoproxil Fumarate or Abacavir/Lamivudine in HIV Infected Treatment-Naive Adults

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ClinicalTrials.gov Identifier: NCT00118898
Recruitment Status : Completed
First Posted : July 12, 2005
Results First Posted : January 10, 2011
Last Update Posted : October 12, 2018
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: Abacavir/Lamivudine
Drug: Atazanavir
Drug: Efavirenz
Drug: Emtricitabine/Tenofovir disoproxil fumarate
Drug: Ritonavir
Drug: Abacavir/Lamivudine placebo
Drug: Emtricitabine/Tenofovir disoproxil fumarate placebo
Enrollment 1864
Recruitment Details Recruited at AIDS Clinical Trials Units in the United States and Puerto Rico. Recruitment occurred between September 21, 2005 (date first subject was randomized) and November 20, 2007 (date last subject was randomized).
Pre-assignment Details 1864 were randomized. Results reported for 1857 eligible participants; 7 were subsequently found ineligible and excluded from all analyses.
Arm/Group Title EFV, FTC/TDF, and Placebo ABC/3TC EFV, Placebo FTC/TDF, and ABC/3TC RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
Hide Arm/Group Description Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Period Title: Overall Study
Started 464 465 465 463
Initiated Treatment 461 461 464 462
Completed 343 324 342 322
Not Completed 121 141 123 141
Reason Not Completed
Death             6             11             6             8
Lost to Follow-up             26             34             33             33
Withdrawal by Subject             10             5             8             8
Site Closure             33             31             28             37
Severe debilitation             1             4             6             4
Not compliant with requirements             11             13             11             11
Not able to get to clinic             34             43             31             40
Arm/Group Title EFV, FTC/TDF, and Placebo ABC/3TC EFV, Placebo FTC/TDF, and ABC/3TC RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC Total
Hide Arm/Group Description Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks Total of all reporting groups
Overall Number of Baseline Participants 464 465 465 463 1857
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 464 participants 465 participants 465 participants 463 participants 1857 participants
<=18 years
2
   0.4%
3
   0.6%
2
   0.4%
3
   0.6%
10
   0.5%
Between 18 and 65 years
461
  99.4%
454
  97.6%
461
  99.1%
458
  98.9%
1834
  98.8%
>=65 years
1
   0.2%
8
   1.7%
2
   0.4%
2
   0.4%
13
   0.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 464 participants 465 participants 465 participants 463 participants 1857 participants
38.2  (9.6) 38.4  (10.5) 38.9  (10.4) 38.0  (9.8) 38.4  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 464 participants 465 participants 465 participants 463 participants 1857 participants
Female
71
  15.3%
98
  21.1%
78
  16.8%
75
  16.2%
322
  17.3%
Male
393
  84.7%
367
  78.9%
387
  83.2%
388
  83.8%
1535
  82.7%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 464 participants 465 participants 465 participants 463 participants 1857 participants
White Non-Hispanic 197 174 186 189 746
Black Non-Hispanic 151 164 147 153 615
Hispanic (Regardless of Race) 104 106 111 108 429
Asian, Pacific Islander 5 8 12 7 32
Native American, Alaskan Native 4 5 3 2 14
More than One Race 2 5 5 4 16
Unknown 1 3 1 0 5
[1]
Measure Description: Race/Ethnicity is collected prior to study entry, participants may opt out of reporting.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 464 participants 465 participants 465 participants 463 participants 1857 participants
United States 451 452 452 450 1805
Puerto Rico 13 13 13 13 52
Baseline HIV-1 RNA   [1] 
Mean (Standard Deviation)
Unit of measure:  Log10 copies/mL
Number Analyzed 464 participants 465 participants 465 participants 463 participants 1857 participants
4.7  (0.7) 4.7  (0.7) 4.7  (0.7) 4.7  (0.7) 4.7  (0.7)
[1]
Measure Description: Baseline RNA is calculated as the mean of the log10 pre-entry and entry values
Screening HIV-1 RNA  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 464 participants 465 participants 465 participants 463 participants 1857 participants
<100,000 copies/mL 265 266 265 264 1060
>=100,000 copies/mL 199 199 200 199 797
Baseline CD4+ count   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Cells/mm3
Number Analyzed 464 participants 465 participants 465 participants 463 participants 1857 participants
233.5
(102.5 to 333.5)
225
(103 to 324)
224
(87.0 to 326.5)
236
(71.5 to 345.5)
229.5
(89.5 to 333.8)
[1]
Measure Description: Baseline CD4 count is the average (mean) of 2 measures taken at pre-entry and entry visits.
1.Primary Outcome
Title Time From Randomization to Virologic Failure
Hide Description Blood samples for determining virologic failure were obtained at visit weeks 16 and 24 , and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks after randomization and before 24 weeks, or >=200 copies/mL at or after 24 weeks. The 5th percentile for time to virologic failure is the time (in weeks) at which 5% of the participants have experienced virologic failure.
Time Frame Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen.
Arm/Group Title EFV, FTC/TDF, and Placebo ABC/3TC EFV, Placebo FTC/TDF, and ABC/3TC RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
Hide Arm/Group Description:
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Overall Number of Participants Analyzed 464 465 465 463
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Weeks
5th percentile time to virologic failure
36
(24 to 60)
24
(16 to 24)
24
(24 to 48)
24
(16 to 24)
10th percentile time to virologic failure
96
(72 to 132)
36
(24 to 60)
84
(48 to 156)
36
(24 to 60)
2.Primary Outcome
Title Time From Treatment Dispensation to a Grade 3/4 Safety Event
Hide Description Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.
Time Frame All follow-up while on initially assigned regimen; the median (25th, 75th percentile) follow-up while on initial regimen was 120 (54, 156) weeks and the range was 0 to 205 weeks.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Participants who initiated treatment are included in this analysis. Follow-up while on initially assigned treatment is included in the at-risk period.
Arm/Group Title EFV, FTC/TDF, and Placebo ABC/3TC EFV, Placebo FTC/TDF, and ABC/3TC RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
Hide Arm/Group Description:
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Overall Number of Participants Analyzed 461 461 464 462
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Weeks
5th percentile time to a grade 3/4 safety event
2.6
(1.6 to 4.3)
1.3
(1.0 to 1.3)
3.0
(1.3 to 4.9)
1.3
(1.0 to 1.7)
10th percentile time to a grade 3/4 safety event
7.9
(4.3 to 13.0)
2.0
(1.3 to 3.9)
8.1
(5.1 to 17.9)
3.9
(1.9 to 7.1)
25th percentile time to a grade 3/4 safety event
59.3
(41.7 to 91.7)
16.0
(8.3 to 22.0)
81.4
(47.9 to 111.3)
44.4
(24.3 to 52.1)
3.Primary Outcome
Title Time From Treatment Dispensation to Treatment Modification
Hide Description Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.
Time Frame Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.
Arm/Group Title EFV, FTC/TDF, and Placebo ABC/3TC EFV, Placebo FTC/TDF, and ABC/3TC RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
Hide Arm/Group Description:
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Overall Number of Participants Analyzed 461 461 464 462
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Weeks
5th percentile time to treatment modification
3.4
(1.6 to 7.1)
1.4
(1.3 to 1.6)
7.9
(2.1 to 14.0)
1.6
(1.3 to 2.4)
10th percentile time to treatment modification
15.0
(7.6 to 23.7)
2.1
(1.6 to 4.1)
24.9
(14.4 to 38.1)
5.0
(2.6 to 12.6)
25th percentile time to treatment modification
83.7
(63.0 to 119.6)
27.4
(21.7 to 34.9)
108.9
(85.1 to 144.1)
43.6
(30.3 to 56.0)
4.Secondary Outcome
Title Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification)
Hide Description Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.
Time Frame Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.
Arm/Group Title EFV, FTC/TDF, and Placebo ABC/3TC EFV, Placebo FTC/TDF, and ABC/3TC RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
Hide Arm/Group Description:
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Overall Number of Participants Analyzed 461 461 464 462
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Weeks
5th percentile time to regimen failure
4
(4 to 4)
4
(4 to 4)
4
(4 to 16)
4
(4 to 4)
10th percentile time to regimen failure
16
(4 to 16)
4
(4 to 4)
16
(16 to 24)
4
(4 to 16)
25th percentile time to regimen failure
72
(48 to 96)
24
(16 to 36)
84
(60 to 108)
36
(24 to 36)
5.Secondary Outcome
Title The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL
Hide Description [Not Specified]
Time Frame At Weeks 48 and 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat: All participants with RNA data were included, complete-case approach.
Arm/Group Title EFV, FTC/TDF, and Placebo ABC/3TC EFV, Placebo FTC/TDF, and ABC/3TC RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
Hide Arm/Group Description:
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Overall Number of Participants Analyzed 464 465 465 463
Measure Type: Number
Unit of Measure: Participants
Number of Participants with RNA data at Week 48 415 400 416 411
Number with HIV-1 RNA <50 copies/ml at Week 48 372 346 348 322
Number of Participants with RNA data at Week 96 379 361 384 374
Number with HIV-1 RNA <50 copies/ml at Week 96 345 328 345 317
6.Secondary Outcome
Title Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL
Hide Description [Not Specified]
Time Frame At Weeks 48 and 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat: All participants with RNA data were included, complete-case approach.
Arm/Group Title EFV, FTC/TDF, and Placebo ABC/3TC EFV, Placebo FTC/TDF, and ABC/3TC RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
Hide Arm/Group Description:
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Overall Number of Participants Analyzed 464 465 465 463
Measure Type: Number
Unit of Measure: Participants
Number of Participants with RNA data at Week 48 415 400 416 411
Number with HIV-1 RNA <200 copies/ml at Week 48 398 377 391 372
Number of Participants with RNA data at Week 96 379 361 384 374
Number with HIV-1 RNA <200 copies/ml at Week 96 362 342 368 346
7.Secondary Outcome
Title Change in CD4 Count (Cells/mm3) From Baseline
Hide Description Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (mean of pre-entry and entry values).
Time Frame At Weeks 48 and 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat: All participants with CD4 data were included, complete-case approach.
Arm/Group Title EFV, FTC/TDF, and Placebo ABC/3TC EFV, Placebo FTC/TDF, and ABC/3TC RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
Hide Arm/Group Description:
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Overall Number of Participants Analyzed 464 465 465 463
Median (Inter-Quartile Range)
Unit of Measure: Cells/mm3
Week 48
163
(96.5 to 250.0)
188
(102.5 to 277.5)
175
(108 to 290)
177.5
(106.0 to 275.5)
Week 96
220.5
(134.5 to 323.5)
250.5
(158.0 to 364.3)
251.5
(165.5 to 362.5)
250.3
(153.0 to 350.0)
8.Secondary Outcome
Title Number of Participants With Virologic Failure and Emergence of Major Resistance
Hide Description Emergence of resistant virus was assessed by genotypic testing performed at Stanford University for all participants who met criteria for virologic failure and retrospectively on baseline samples from these participants. Major mutations were defined by International AIDS Society-United States of America (2008), as well as T69D, L74I, G190C/E/Q/T/V for reverse transcriptase and L24I, F53L, I54V/A/T/S, G73C/S/T/A, N88D for protease.
Time Frame Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat: All eligible participants are included. Participants were analyzed per originally assigned regimen.
Arm/Group Title EFV, FTC/TDF, and Placebo ABC/3TC EFV, Placebo FTC/TDF, and ABC/3TC RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
Hide Arm/Group Description:
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Overall Number of Participants Analyzed 464 465 465 463
Measure Type: Number
Unit of Measure: participants
27 41 5 12
9.Secondary Outcome
Title Number of Participants Experiencing Certain Targeted Clinical Events, Including Death, AIDS-defining Illness, and HIV-1 Related Events.
Hide Description

AIDS-defining illnesses were defined per CDC category C definition. HIV-1 related events were defined per CDC category B definition. Events underwent study chair review for classification. See link below for more details.

http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm

Time Frame Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen.
Arm/Group Title EFV, FTC/TDF, and Placebo ABC/3TC EFV, Placebo FTC/TDF, and ABC/3TC RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
Hide Arm/Group Description:
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Overall Number of Participants Analyzed 464 465 465 463
Measure Type: Number
Unit of Measure: Participants
Death 6 11 6 8
AIDS-defining illness 14 25 20 23
HIV-1 relatated event 56 61 57 63
10.Secondary Outcome
Title Change in Fasting Total Cholesterol Level From Baseline
Hide Description Only fasting results are included. The protocol did not require that samples be collected fasting.
Time Frame At Weeks 48 and 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat: All participants with fasting lipids data were included, complete-case approach.
Arm/Group Title EFV, FTC/TDF, and Placebo ABC/3TC EFV, Placebo FTC/TDF, and ABC/3TC RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
Hide Arm/Group Description:
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Overall Number of Participants Analyzed 464 465 465 463
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
Week 48
22
(2 to 43)
35
(15.5 to 58)
11
(-9 to 36)
30
(9 to 54)
Week 96
23
(2 to 41)
33
(10 to 60)
14
(-6 to 39)
25
(7 to 50)
11.Secondary Outcome
Title Change in Fasting High-density Lipoprotein (HDL) Cholesterol Level From Baseline
Hide Description Only fasting results are included. The protocol did not require that samples be collected fasting.
Time Frame At Weeks 48 and 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat: All participants with fasting lipids data were included, complete-case approach.
Arm/Group Title EFV, FTC/TDF, and Placebo ABC/3TC EFV, Placebo FTC/TDF, and ABC/3TC RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
Hide Arm/Group Description:
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Overall Number of Participants Analyzed 464 465 465 463
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
Week 48
8
(3 to 15)
10
(4 to 18)
5
(-2 to 10)
8
(1 to 16)
Week 96
9
(2 to 16)
11
(3.5 to 18.5)
4
(-1 to 11)
7
(1 to 15)
12.Secondary Outcome
Title Change in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Level From Baseline
Hide Description Only fasting results are included. The protocol did not require that samples be collected fasting.
Time Frame At Weeks 48 and 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat: All participants with fasting lipids data were included, complete-case approach.
Arm/Group Title EFV, FTC/TDF, and Placebo ABC/3TC EFV, Placebo FTC/TDF, and ABC/3TC RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
Hide Arm/Group Description:
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Overall Number of Participants Analyzed 464 465 465 463
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
Week 48
14
(-4.5 to 30.5)
23
(3 to 47)
8
(-11 to 30)
20
(-1 to 42)
Week 96
13.5
(-5.5 to 31.0)
18
(0 to 45)
10
(-9.5 to 34.0)
18
(2 to 43)
13.Secondary Outcome
Title Change in Fasting Triglyceride Level From Baseline
Hide Description Only fasting results are included. The protocol did not require that samples be collected fasting.
Time Frame At Weeks 48 and 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat: All participants with fasting lipids data were included, complete-case approach.
Arm/Group Title EFV, FTC/TDF, and Placebo ABC/3TC EFV, Placebo FTC/TDF, and ABC/3TC RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
Hide Arm/Group Description:
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Overall Number of Participants Analyzed 464 465 465 463
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
Week 48
10
(-29 to 44)
15
(-20 to 65)
14
(-18 to 52)
24
(-12 to 80)
Week 96
9
(-27 to 48)
14
(-22 to 54)
11
(-21 to 47)
33
(-9 to 78)
14.Other Pre-specified Outcome
Title Amount of Study Follow-up
Hide Description Participants were to be followed for 96 weeks after the last enrollment. Accrual was expected to take 96 weeks, thus the planned follow-up time was 96 to 192 weeks, dependent on when in the study the participant enrolled. This outcome summarizes that total amount of actual follow-up in weeks from randomization to last contact.
Time Frame Follow-up time was variable, median follow-up was 138 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat: All eligible participants are included. Participants were analyzed per originally assigned regimen.
Arm/Group Title EFV, FTC/TDF, and Placebo ABC/3TC EFV, Placebo FTC/TDF, and ABC/3TC RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
Hide Arm/Group Description:
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Overall Number of Participants Analyzed 464 465 465 463
Median (Inter-Quartile Range)
Unit of Measure: Weeks
141.4
(108 to 169)
133.3
(101.3 to 168.0)
141.6
(105.9 to 168.1)
137.3
(106.0 to 169.1)
15.Other Pre-specified Outcome
Title Number of Participants With Virologic Failure
Hide Description Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks.
Time Frame Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen.
Arm/Group Title EFV, FTC/TDF, and Placebo ABC/3TC EFV, Placebo FTC/TDF, and ABC/3TC RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
Hide Arm/Group Description:
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Overall Number of Participants Analyzed 464 465 465 463
Measure Type: Number
Unit of Measure: participants
57 72 57 83
16.Other Pre-specified Outcome
Title Cumulative Probability of Not Experiencing Virologic Failure
Hide Description Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks.
Time Frame At week 48 and 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen.
Arm/Group Title EFV, FTC/TDF, and Placebo ABC/3TC EFV, Placebo FTC/TDF, and ABC/3TC RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
Hide Arm/Group Description:
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Overall Number of Participants Analyzed 464 465 465 463
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 48
94
(91 to 96)
88
(85 to 91)
92
(89 to 94)
88
(84 to 90)
Week 96
90
(87 to 92)
85
(82 to 88)
89
(86 to 92)
83
(79 to 87)
17.Other Pre-specified Outcome
Title Number of Participants With a Grade 3/4 Safety Event
Hide Description Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded.
Time Frame Over all study follow-up while on initially assigned treatment, median follow-up was 120 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Participants who initiated treatment are included in this analysis. Follow-up while on initially assigned treatment is included in the at-risk period.
Arm/Group Title EFV, FTC/TDF, and Placebo ABC/3TC EFV, Placebo FTC/TDF, and ABC/3TC RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
Hide Arm/Group Description:
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Overall Number of Participants Analyzed 461 461 464 462
Measure Type: Number
Unit of Measure: participants
145 182 137 156
18.Other Pre-specified Outcome
Title Cumulative Probability of Not Experiencing a Grade 3/4 Safety Event
Hide Description Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded.
Time Frame At week 48 and 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated: Participants who initiated treatment are included in this analysis. Follow-up while on initially assigned treatment is included in the at-risk period.
Arm/Group Title EFV, FTC/TDF, and Placebo ABC/3TC EFV, Placebo FTC/TDF, and ABC/3TC RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
Hide Arm/Group Description:
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Overall Number of Participants Analyzed 461 461 464 462
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 48
78
(73 to 81)
64
(60 to 69)
79
(75 to 82)
73
(68 to 77)
Week 96
70
(65 to 74)
58
(53 to 63)
73
(68 to 77)
66
(61 to 70)
19.Other Pre-specified Outcome
Title Number of Participants With Treatment Modification
Hide Description Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.
Time Frame Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.
Arm/Group Title EFV, FTC/TDF, and Placebo ABC/3TC EFV, Placebo FTC/TDF, and ABC/3TC RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
Hide Arm/Group Description:
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Overall Number of Participants Analyzed 461 461 464 462
Measure Type: Number
Unit of Measure: participants
152 239 138 216
20.Other Pre-specified Outcome
Title Cumulative Probability of Not Experiencing Treatment Modification
Hide Description Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.
Time Frame At week 48 and 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.
Arm/Group Title EFV, FTC/TDF, and Placebo ABC/3TC EFV, Placebo FTC/TDF, and ABC/3TC RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
Hide Arm/Group Description:
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Overall Number of Participants Analyzed 461 461 464 462
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 48
80
(76 to 84)
67
(63 to 71)
86
(82 to 89)
73
(69 to 77)
Week 96
73
(69 to 77)
56
(52 to 61)
77
(73 to 81)
62
(58 to 66)
21.Other Pre-specified Outcome
Title Number of Participants With Regimen Failure
Hide Description Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.
Time Frame Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.
Arm/Group Title EFV, FTC/TDF, and Placebo ABC/3TC EFV, Placebo FTC/TDF, and ABC/3TC RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
Hide Arm/Group Description:
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Overall Number of Participants Analyzed 461 461 464 462
Measure Type: Number
Unit of Measure: participants
162 246 157 233
22.Other Pre-specified Outcome
Title Cumulative Probability of Not Experiencing Regimen Failure
Hide Description Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.
Time Frame At week 48 and 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.
Arm/Group Title EFV, FTC/TDF, and Placebo ABC/3TC EFV, Placebo FTC/TDF, and ABC/3TC RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
Hide Arm/Group Description:
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Overall Number of Participants Analyzed 461 461 464 462
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 48
79
(75 to 82)
64
(59 to 68)
80
(76 to 84)
66
(62 to 70)
Week 96
70
(66 to 74)
54
(49 to 58)
73
(69 to 77)
57
(52 to 61)
Time Frame From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Adverse Event Reporting Description Grade≥2 CNS, nausea, diarrhea & other Grade>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events & diseases. All Creatinine, bilirubin, fasting lipid & glucose, and other Grade>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
 
Arm/Group Title EFV, FTC/TDF, and Placebo ABC/3TC EFV, Placebo FTC/TDF, and ABC/3TC RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
Hide Arm/Group Description Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
All-Cause Mortality
EFV, FTC/TDF, and Placebo ABC/3TC EFV, Placebo FTC/TDF, and ABC/3TC RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
EFV, FTC/TDF, and Placebo ABC/3TC EFV, Placebo FTC/TDF, and ABC/3TC RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   48/461 (10.41%)   62/461 (13.45%)   58/464 (12.50%)   71/462 (15.37%) 
Blood and lymphatic system disorders         
Anaemia  2/461 (0.43%)  1/461 (0.22%)  1/464 (0.22%)  0/462 (0.00%) 
Burkitt's lymphoma  0/461 (0.00%)  1/461 (0.22%)  0/464 (0.00%)  0/462 (0.00%) 
Idiopathic thrombocytopenic purpura  1/461 (0.22%)  0/461 (0.00%)  0/464 (0.00%)  0/462 (0.00%) 
Leukopenia  1/461 (0.22%)  0/461 (0.00%)  0/464 (0.00%)  0/462 (0.00%) 
Lymphadenitis  1/461 (0.22%)  0/461 (0.00%)  0/464 (0.00%)  0/462 (0.00%) 
Lymphadenopathy  0/461 (0.00%)  0/461 (0.00%)  1/464 (0.22%)  0/462 (0.00%) 
Neutropenia  0/461 (0.00%)  1/461 (0.22%)  1/464 (0.22%)  1/462 (0.22%) 
Thrombocytopenia  0/461 (0.00%)  0/461 (0.00%)  0/464 (0.00%)  2/462 (0.43%) 
Cardiac disorders         
Acute myocardial infarction  2/461 (0.43%)  0/461 (0.00%)  0/464 (0.00%)  0/462 (0.00%) 
Cardiovascular disorder  1/461 (0.22%)  0/461 (0.00%)  0/464 (0.00%)  0/462 (0.00%) 
Coronary artery disease  1/461 (0.22%)  0/461 (0.00%)  0/464 (0.00%)  0/462 (0.00%) 
Myocardial infarction  1/461 (0.22%)  0/461 (0.00%)  0/464 (0.00%)  0/462 (0.00%) 
Pericarditis  0/461 (0.00%)  0/461 (0.00%)  0/464 (0.00%)  1/462 (0.22%) 
Congenital, familial and genetic disorders         
Ventricular septal defect  0/461 (0.00%)  1/461 (0.22%)  0/464 (0.00%)  0/462 (0.00%) 
Gastrointestinal disorders         
Abdominal pain  0/461 (0.00%)  0/461 (0.00%)  2/464 (0.43%)  1/462 (0.22%) 
Diarrhoea  0/461 (0.00%)  1/461 (0.22%)  0/464 (0.00%)  0/462 (0.00%) 
Intestinal perforation  0/461 (0.00%)  1/461 (0.22%)  0/464 (0.00%)  0/462 (0.00%) 
Pancreatitis acute  0/461 (0.00%)  0/461 (0.00%)  0/464 (0.00%)  3/462 (0.65%) 
Vomiting  0/461 (0.00%)  0/461 (0.00%)  1/464 (0.22%)  1/462 (0.22%) 
General disorders         
Accidental death  0/461 (0.00%)  1/461 (0.22%)  0/464 (0.00%)  0/462 (0.00%) 
Adverse drug reaction  0/461 (0.00%)  1/461 (0.22%)  0/464 (0.00%)  0/462 (0.00%) 
Cardio-respiratory arrest  0/461 (0.00%)  0/461 (0.00%)  1/464 (0.22%)  0/462 (0.00%) 
Chest pain  0/461 (0.00%)  1/461 (0.22%)  3/464 (0.65%)  0/462 (0.00%) 
Death  1/461 (0.22%)  5/461 (1.08%)  1/464 (0.22%)  2/462 (0.43%) 
Malaise  1/461 (0.22%)  0/461 (0.00%)  0/464 (0.00%)  0/462 (0.00%) 
Pain  1/461 (0.22%)  0/461 (0.00%)  0/464 (0.00%)  0/462 (0.00%) 
Pyrexia  0/461 (0.00%)  3/461 (0.65%)  1/464 (0.22%)  0/462 (0.00%) 
Hepatobiliary disorders         
Cholecystitis  1/461 (0.22%)  0/461 (0.00%)  0/464 (0.00%)  0/462 (0.00%) 
Hepatitis  0/461 (0.00%)  0/461 (0.00%)  0/464 (0.00%)  2/462 (0.43%) 
Hyperbilirubinaemia  0/461 (0.00%)  0/461 (0.00%)  13/464 (2.80%)  14/462 (3.03%) 
Immune system disorders         
Drug hypersensitivity  1/461 (0.22%)  5/461 (1.08%)  2/464 (0.43%)  7/462 (1.52%) 
Hypersensitivity  1/461 (0.22%)  0/461 (0.00%)  0/464 (0.00%)  2/462 (0.43%) 
Infections and infestations         
Cellulitis  0/461 (0.00%)  0/461 (0.00%)  0/464 (0.00%)  1/462 (0.22%) 
Clostridium difficile colitis  0/461 (0.00%)  0/461 (0.00%)  0/464 (0.00%)  1/462 (0.22%) 
Gastroenteritis  0/461 (0.00%)  0/461 (0.00%)  0/464 (0.00%)  1/462 (0.22%) 
HIV infection  0/461 (0.00%)  0/461 (0.00%)  2/464 (0.43%)  1/462 (0.22%) 
Hepatitis C  0/461 (0.00%)  1/461 (0.22%)  0/464 (0.00%)  1/462 (0.22%) 
Lung infection pseudomonal  1/461 (0.22%)  0/461 (0.00%)  0/464 (0.00%)  0/462 (0.00%) 
Meningitis cryptococcal  1/461 (0.22%)  0/461 (0.00%)  0/464 (0.00%)  0/462 (0.00%) 
Mycobacterium avium complex infection  0/461 (0.00%)  0/461 (0.00%)  0/464 (0.00%)  1/462 (0.22%) 
Pharyngitis  0/461 (0.00%)  0/461 (0.00%)  0/464 (0.00%)  1/462 (0.22%) 
Pneumocystis jiroveci pneumonia  1/461 (0.22%)  0/461 (0.00%)  1/464 (0.22%)  0/462 (0.00%) 
Pneumonia  0/461 (0.00%)  0/461 (0.00%)  2/464 (0.43%)  0/462 (0.00%) 
Injury, poisoning and procedural complications         
Drug toxicity  0/461 (0.00%)  0/461 (0.00%)  0/464 (0.00%)  1/462 (0.22%) 
Multiple drug overdose  0/461 (0.00%)  0/461 (0.00%)  1/464 (0.22%)  0/462 (0.00%) 
Narcotic intoxication  0/461 (0.00%)  1/461 (0.22%)  0/464 (0.00%)  0/462 (0.00%) 
Overdose  1/461 (0.22%)  0/461 (0.00%)  0/464 (0.00%)  0/462 (0.00%) 
Road traffic accident  0/461 (0.00%)  0/461 (0.00%)  0/464 (0.00%)  1/462 (0.22%) 
Spinal compression fracture  1/461 (0.22%)  0/461 (0.00%)  0/464 (0.00%)  0/462 (0.00%) 
Investigations         
Alanine aminotransferase increased  1/461 (0.22%)  2/461 (0.43%)  0/464 (0.00%)  2/462 (0.43%) 
Aspartate aminotransferase increased  0/461 (0.00%)  2/461 (0.43%)  1/464 (0.22%)  2/462 (0.43%) 
Blood alkaline phosphatase increased  0/461 (0.00%)  0/461 (0.00%)  1/464 (0.22%)  0/462 (0.00%) 
Blood bilirubin increased  0/461 (0.00%)  1/461 (0.22%)  14/464 (3.02%)  5/462 (1.08%) 
Blood creatinine increased  0/461 (0.00%)  0/461 (0.00%)  1/464 (0.22%)  0/462 (0.00%) 
Blood triglycerides  0/461 (0.00%)  0/461 (0.00%)  0/464 (0.00%)  1/462 (0.22%) 
Blood triglycerides increased  2/461 (0.43%)  4/461 (0.87%)  0/464 (0.00%)  2/462 (0.43%) 
Lipase increased  1/461 (0.22%)  3/461 (0.65%)  1/464 (0.22%)  0/462 (0.00%) 
Liver function test abnormal  1/461 (0.22%)  1/461 (0.22%)  1/464 (0.22%)  3/462 (0.65%) 
Neutrophil count decreased  0/461 (0.00%)  0/461 (0.00%)  1/464 (0.22%)  0/462 (0.00%) 
Transaminases increased  2/461 (0.43%)  0/461 (0.00%)  0/464 (0.00%)  0/462 (0.00%) 
Metabolism and nutrition disorders         
Hyperglycaemia  1/461 (0.22%)  0/461 (0.00%)  0/464 (0.00%)  1/462 (0.22%) 
Hypertriglyceridaemia  1/461 (0.22%)  3/461 (0.65%)  0/464 (0.00%)  2/462 (0.43%) 
Hyponatraemia  0/461 (0.00%)  0/461 (0.00%)  0/464 (0.00%)  1/462 (0.22%) 
Lactic acidosis  2/461 (0.43%)  0/461 (0.00%)  0/464 (0.00%)  0/462 (0.00%) 
Musculoskeletal and connective tissue disorders         
Pain in extremity  1/461 (0.22%)  0/461 (0.00%)  0/464 (0.00%)  0/462 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Anal cancer  0/461 (0.00%)  0/461 (0.00%)  1/464 (0.22%)  0/462 (0.00%) 
Burkitt's lymphoma  0/461 (0.00%)  1/461 (0.22%)  0/464 (0.00%)  1/462 (0.22%) 
Gastric cancer  0/461 (0.00%)  1/461 (0.22%)  0/464 (0.00%)  0/462 (0.00%) 
Hodgkin's disease  1/461 (0.22%)  0/461 (0.00%)  0/464 (0.00%)  1/462 (0.22%) 
Inflammatory carcinoma of the breast  0/461 (0.00%)  1/461 (0.22%)  0/464 (0.00%)  0/462 (0.00%) 
Lung neoplasm malignant  0/461 (0.00%)  0/461 (0.00%)  1/464 (0.22%)  0/462 (0.00%) 
Lymphoma  0/461 (0.00%)  1/461 (0.22%)  1/464 (0.22%)  0/462 (0.00%) 
Metastatic neoplasm  0/461 (0.00%)  1/461 (0.22%)  0/464 (0.00%)  0/462 (0.00%) 
Non-Hodgkin's lymphoma  0/461 (0.00%)  0/461 (0.00%)  0/464 (0.00%)  1/462 (0.22%) 
Non-small cell lung cancer  0/461 (0.00%)  0/461 (0.00%)  1/464 (0.22%)  0/462 (0.00%) 
Nervous system disorders         
Altered state of consciousness  1/461 (0.22%)  0/461 (0.00%)  0/464 (0.00%)  0/462 (0.00%) 
Cerebrovascular accident  1/461 (0.22%)  1/461 (0.22%)  0/464 (0.00%)  0/462 (0.00%) 
Convulsion  0/461 (0.00%)  2/461 (0.43%)  0/464 (0.00%)  0/462 (0.00%) 
Demyelinating polyneuropathy  0/461 (0.00%)  0/461 (0.00%)  1/464 (0.22%)  0/462 (0.00%) 
Dizziness  2/461 (0.43%)  0/461 (0.00%)  0/464 (0.00%)  0/462 (0.00%) 
Headache  0/461 (0.00%)  0/461 (0.00%)  1/464 (0.22%)  0/462 (0.00%) 
Loss of consciousness  0/461 (0.00%)  1/461 (0.22%)  0/464 (0.00%)  0/462 (0.00%) 
Neurotoxicity  0/461 (0.00%)  1/461 (0.22%)  0/464 (0.00%)  0/462 (0.00%) 
Peripheral sensory neuropathy  0/461 (0.00%)  0/461 (0.00%)  0/464 (0.00%)  1/462 (0.22%) 
Status epilepticus  0/461 (0.00%)  0/461 (0.00%)  1/464 (0.22%)  0/462 (0.00%) 
Transient global amnesia  0/461 (0.00%)  0/461 (0.00%)  0/464 (0.00%)  1/462 (0.22%) 
VIIth nerve paralysis  1/461 (0.22%)  0/461 (0.00%)  0/464 (0.00%)  0/462 (0.00%) 
Pregnancy, puerperium and perinatal conditions         
Abortion spontaneous  1/461 (0.22%)  3/461 (0.65%)  0/464 (0.00%)  1/462 (0.22%) 
Ectopic pregnancy  0/461 (0.00%)  1/461 (0.22%)  0/464 (0.00%)  0/462 (0.00%) 
Intra-uterine death  1/461 (0.22%)  3/461 (0.65%)  0/464 (0.00%)  0/462 (0.00%) 
Psychiatric disorders         
Completed suicide  0/461 (0.00%)  0/461 (0.00%)  0/464 (0.00%)  1/462 (0.22%) 
Depression  0/461 (0.00%)  1/461 (0.22%)  0/464 (0.00%)  0/462 (0.00%) 
Depression suicidal  0/461 (0.00%)  0/461 (0.00%)  0/464 (0.00%)  1/462 (0.22%) 
Mental status changes  1/461 (0.22%)  0/461 (0.00%)  0/464 (0.00%)  0/462 (0.00%) 
Personality change  1/461 (0.22%)  0/461 (0.00%)  0/464 (0.00%)  0/462 (0.00%) 
Psychotic disorder  0/461 (0.00%)  1/461 (0.22%)  0/464 (0.00%)  0/462 (0.00%) 
Suicidal ideation  2/461 (0.43%)  3/461 (0.65%)  0/464 (0.00%)  1/462 (0.22%) 
Suicide attempt  3/461 (0.65%)  2/461 (0.43%)  1/464 (0.22%)  0/462 (0.00%) 
Renal and urinary disorders         
Nephrolithiasis  0/461 (0.00%)  1/461 (0.22%)  3/464 (0.65%)  1/462 (0.22%) 
Renal failure acute  0/461 (0.00%)  1/461 (0.22%)  0/464 (0.00%)  1/462 (0.22%) 
Reproductive system and breast disorders         
Adenomyosis  1/461 (0.22%)  0/461 (0.00%)  0/464 (0.00%)  0/462 (0.00%) 
Ovarian mass  1/461 (0.22%)  0/461 (0.00%)  0/464 (0.00%)  0/462 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pneumonia aspiration  1/461 (0.22%)  0/461 (0.00%)  0/464 (0.00%)  0/462 (0.00%) 
Skin and subcutaneous tissue disorders         
Drug eruption  0/461 (0.00%)  1/461 (0.22%)  0/464 (0.00%)  0/462 (0.00%) 
Exfoliative rash  0/461 (0.00%)  0/461 (0.00%)  0/464 (0.00%)  1/462 (0.22%) 
Rash  0/461 (0.00%)  3/461 (0.65%)  1/464 (0.22%)  2/462 (0.43%) 
Rash maculo-papular  1/461 (0.22%)  0/461 (0.00%)  0/464 (0.00%)  0/462 (0.00%) 
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
EFV, FTC/TDF, and Placebo ABC/3TC EFV, Placebo FTC/TDF, and ABC/3TC RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   434/461 (94.14%)   433/461 (93.93%)   453/464 (97.63%)   461/462 (99.78%) 
Gastrointestinal disorders         
Diarrhoea  54/461 (11.71%)  78/461 (16.92%)  61/464 (13.15%)  81/462 (17.53%) 
Nausea  58/461 (12.58%)  77/461 (16.70%)  51/464 (10.99%)  86/462 (18.61%) 
Vomiting  24/461 (5.21%)  43/461 (9.33%)  24/464 (5.17%)  38/462 (8.23%) 
General disorders         
Fatigue  41/461 (8.89%)  49/461 (10.63%)  24/464 (5.17%)  35/462 (7.58%) 
Pyrexia  20/461 (4.34%)  52/461 (11.28%)  36/464 (7.76%)  50/462 (10.82%) 
Immune system disorders         
Drug hypersensitivity  22/461 (4.77%)  49/461 (10.63%)  29/464 (6.25%)  30/462 (6.49%) 
Investigations         
Alanine aminotransferase increased  67/461 (14.53%)  70/461 (15.18%)  53/464 (11.42%)  52/462 (11.26%) 
Aspartate aminotransferase increased  73/461 (15.84%)  67/461 (14.53%)  63/464 (13.58%)  61/462 (13.20%) 
Blood bilirubin increased  47/461 (10.20%)  57/461 (12.36%)  412/464 (88.79%)  430/462 (93.07%) 
Blood cholesterol  51/461 (11.06%)  70/461 (15.18%)  40/464 (8.62%)  59/462 (12.77%) 
Blood cholesterol abnormal  220/461 (47.72%)  282/461 (61.17%)  179/464 (38.58%)  267/462 (57.79%) 
Blood creatinine increased  21/461 (4.56%)  27/461 (5.86%)  42/464 (9.05%)  32/462 (6.93%) 
Blood glucose abnormal  184/461 (39.91%)  195/461 (42.30%)  180/464 (38.79%)  202/462 (43.72%) 
Blood glucose decreased  34/461 (7.38%)  24/461 (5.21%)  26/464 (5.60%)  28/462 (6.06%) 
Blood phosphorus decreased  36/461 (7.81%)  32/461 (6.94%)  29/464 (6.25%)  29/462 (6.28%) 
Blood sodium decreased  38/461 (8.24%)  45/461 (9.76%)  48/464 (10.34%)  35/462 (7.58%) 
Blood triglycerides  25/461 (5.42%)  49/461 (10.63%)  18/464 (3.88%)  46/462 (9.96%) 
Haemoglobin decreased  19/461 (4.12%)  27/461 (5.86%)  18/464 (3.88%)  24/462 (5.19%) 
Low density lipoprotein  40/461 (8.68%)  55/461 (11.93%)  27/464 (5.82%)  42/462 (9.09%) 
Low density lipoprotein abnormal  188/461 (40.78%)  228/461 (49.46%)  156/464 (33.62%)  205/462 (44.37%) 
Neutrophil count decreased  79/461 (17.14%)  88/461 (19.09%)  69/464 (14.87%)  71/462 (15.37%) 
Platelet count decreased  28/461 (6.07%)  27/461 (5.86%)  25/464 (5.39%)  25/462 (5.41%) 
White blood cell count decreased  43/461 (9.33%)  47/461 (10.20%)  37/464 (7.97%)  36/462 (7.79%) 
Musculoskeletal and connective tissue disorders         
Pain in extremity  12/461 (2.60%)  25/461 (5.42%)  9/464 (1.94%)  25/462 (5.41%) 
Nervous system disorders         
Dizziness  42/461 (9.11%)  53/461 (11.50%)  16/464 (3.45%)  9/462 (1.95%) 
Headache  37/461 (8.03%)  41/461 (8.89%)  29/464 (6.25%)  42/462 (9.09%) 
Psychiatric disorders         
Abnormal dreams  20/461 (4.34%)  26/461 (5.64%)  2/464 (0.43%)  3/462 (0.65%) 
Depression  41/461 (8.89%)  40/461 (8.68%)  34/464 (7.33%)  42/462 (9.09%) 
Insomnia  28/461 (6.07%)  33/461 (7.16%)  8/464 (1.72%)  20/462 (4.33%) 
Respiratory, thoracic and mediastinal disorders         
Cough  16/461 (3.47%)  23/461 (4.99%)  15/464 (3.23%)  27/462 (5.84%) 
Skin and subcutaneous tissue disorders         
Rash  17/461 (3.69%)  26/461 (5.64%)  18/464 (3.88%)  25/462 (5.41%) 
Rash generalised  10/461 (2.17%)  29/461 (6.29%)  9/464 (1.94%)  20/462 (4.33%) 
Vascular disorders         
Hypertension  29/461 (6.29%)  27/461 (5.86%)  14/464 (3.02%)  27/462 (5.84%) 
1
Term from vocabulary, MedDRA 13.1
HIV-1 drug resistance testing and HLA-B*5701 testing were not standard of care during enrollment. EFV and RTV-boosted ATV were open-label, and blinded FTC/TDF vs. ABC/3TC were unblinded in the >=100,000 cp/mL screening viral load stratum Feb 2008.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: ACTG ClinicalTrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00118898     History of Changes
Other Study ID Numbers: ACTG A5202
1U01AI068636 ( U.S. NIH Grant/Contract )
ACTG 5224s ( Other Identifier: Substudy )
First Submitted: July 7, 2005
First Posted: July 12, 2005
Results First Submitted: January 8, 2010
Results First Posted: January 10, 2011
Last Update Posted: October 12, 2018