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Abacavir/Lamivudine Versus Emtricitabine/Tenofovir Both In Combination With Lopinavir/Ritonavir For The Treatment Of HIV (HEAT)

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ClinicalTrials.gov Identifier: NCT00244712
Recruitment Status : Completed
First Posted : October 27, 2005
Results First Posted : September 15, 2009
Last Update Posted : June 8, 2010
Sponsor:
Information provided by:
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition HIV Infection
Interventions Drug: emtricitabine/tenofovir
Drug: abacavir/lamivudine
Enrollment 688
Recruitment Details Participants were recruited at 76 study sites in the US and 2 study sites in Puerto Rico between 26 July 2005 and 16 June 2006.
Pre-assignment Details After screening, participants who had never received treatment for HIV-1 infection and had a viral load greater than or equal to 1,000 copies per milliliter of blood and any amount of CD4+ T-cells were equally randomized to 1 of 2 treatment groups.
Arm/Group Title Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
Hide Arm/Group Description 1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily 1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
Period Title: Overall Study
Started 343 345
Completed 234 221
Not Completed 109 124
Reason Not Completed
Adverse Event             20             21
Protocol-Defined Virologic Failure             8             6
Lack of Compliance             10             11
Lost to Follow-up             45             52
Withdrawal by Subject             13             23
Protocol Violation, disease progression             13             11
Arm/Group Title Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV Total
Hide Arm/Group Description 1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily 1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily Total of all reporting groups
Overall Number of Baseline Participants 343 345 688
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 343 participants 345 participants 688 participants
38.0  (9.80) 38.7  (9.55) 38.3  (9.68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 343 participants 345 participants 688 participants
Female
56
  16.3%
69
  20.0%
125
  18.2%
Male
287
  83.7%
276
  80.0%
563
  81.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 343 participants 345 participants 688 participants
African American/African Heritage 122 124 246
American Indian or Alaskan Native 0 1 1
Asian 6 9 15
White 177 174 351
Mixed Race 2 1 3
Unspecified 36 36 72
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 343 participants 345 participants 688 participants
Hispanic or Latino 73 62 135
Not Hispanic or Latino 270 282 552
Missing Information 0 1 1
Baseline CD4+ Cell Count Level  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 343 participants 345 participants 688 participants
<50 cells per cmm 61 70 131
50 - <200 cells per cmm 99 110 209
>= 200 cells per cmm 183 165 348
Baseline HIV-1 RNA Level  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 343 participants 345 participants 688 participants
<100,000 copies/mL 188 205 393
100,000 - <250,000 copies/mL 68 75 143
250,000 - <500,000 copies/mL 37 33 70
>=500,000 copies/mL 50 32 82
Centers for Disease Control (CDC) Classification   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 343 participants 345 participants 688 participants
A: Asymptomatic HIV infection 229 240 469
B: Symptomatic HIV infection 59 48 107
C: AIDS 55 57 112
[1]
Measure Description: HIV, Human Immunodeficiency Virus; AIDS, Acquired Immunodeficiency Syndrome
Hepatitis B Infection  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 343 participants 345 participants 688 participants
Reactive 19 9 28
Non-Reactive 324 334 658
Missing 0 2 2
Hepatitis C Infection  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 343 participants 345 participants 688 participants
Reactive 27 24 51
Non-Reactive 316 319 635
Missing 0 2 2
Baseline CD4+ Cell Count  
Median (Full Range)
Unit of measure:  Cells per cmm
Number Analyzed 343 participants 345 participants 688 participants
214
(19 to 962)
193
(19 to 953)
202
(19 to 962)
Baseline HIV-1 RNA   [1] 
Median (Full Range)
Unit of measure:  Log10 copies/mL
Number Analyzed 343 participants 345 participants 688 participants
4.903
(2.658 to 6.994)
4.844
(1.690 to 6.565)
4.876
(1.690 to 6.994)
[1]
Measure Description: HIV-1 RNA, Human Immunodeficiency Virus type 1 Ribonucleic acid
1.Primary Outcome
Title Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 by Missing=Failure (M=F), Switched Included Analysis.
Hide Description A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48. The percentage of participants with HIV-1 RNA <50 copies/mL were tabulated by treatment arm with stratification by baseline HIV-1 RNA (<100,000 copies/mL and >=100,000 copies/mL).
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat-Exposed (ITT-E) population which included all randomized participants that had received at least one dose of study medication. In the missing=failure, switched included analysis, participants who had switched their randomized treatment for other treatment were considered as failures, i.e., HIV-1 RNA >=50 copies/mL.
Arm/Group Title Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
Hide Arm/Group Description:
1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
Overall Number of Participants Analyzed 343 345
Measure Type: Number
Unit of Measure: percentage of participants
67.5 67.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV), Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority of the ABC/3TC to the TDF/FTC would be declared if the lower limit of the 2-sided 95% confidence interval on the difference in the percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 [ABC/3TC minus TDF/FTC] was -12% or greater.
Statistical Test of Hypothesis P-Value 0.913
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in response percentage
Estimated Value 0.39
Confidence Interval 95%
-6.63 to 7.40
Estimation Comments Difference in response percentage = percentage in Arm 1 minus percentage in Arm 2
2.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
Hide Description A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL).
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat-Exposed (ITT-E) population which included all patients that had received at least one dose of study medication. The secondary analysis methods were time to loss of virologic response (TLOVR), Observed (Obs), and missing/discontinuation=failure (M/D=F) analyses.
Arm/Group Title Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
Hide Arm/Group Description:
1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
Overall Number of Participants Analyzed 343 345
Measure Type: Number
Unit of Measure: percentage of participants
TLOVR 62.6 61.1
Obs 84.3 86.8
M/D=F 64.3 62.3
3.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
Hide Description A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 96 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL).
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were M=F, switch included, TLOVR, Observed, and M/D=F.
Arm/Group Title Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
Hide Arm/Group Description:
1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
Overall Number of Participants Analyzed 343 345
Measure Type: Number
Unit of Measure: percentage of participants
M=F, Switch Included 59.9 58.0
TLOVR 52.1 51.0
Obs 86.9 91.3
M/D=F 56.4 54.5
4.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
Hide Description A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA <100,000 copies/mL.
Time Frame Weeks 48 and 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were missing=failure (M=F), switch included, TLOVR, Observed, and M/D=F
Arm/Group Title Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
Hide Arm/Group Description:
1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
Overall Number of Participants Analyzed 188 205
Measure Type: Number
Unit of Measure: percentage of participants
M=F, Switch Included, Week 48 71 69
TLOVR, Week 48 67 62
Obs, Week 48 89 88
MD=F, Week 48 68 62
M=F, Switch Included, Week 96 63 58
TLOVR, Week 96 57 52
Obs, Week 96 89 94
MD=F, Week 96 59 54
5.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
Hide Description A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48 and 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA >=100,000 copies/mL.
Time Frame Weeks 48 and 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were M=F, switch included, TLOVR, Observed, and M/D=F
Arm/Group Title Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
Hide Arm/Group Description:
1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
Overall Number of Participants Analyzed 155 140
Measure Type: Number
Unit of Measure: percentage of participants
M=F, Switch Included, Week 48 63 65
TLOVR, Week 48 57 60
Obs, Week 48 78 86
M/D=F, Week 48 59 62
M=F, Switch Included, Week 96 56 58
TLOVR, Week 96 46 51
Obs, Week 96 84 88
M/D=F, Week 96 54 55
6.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96
Hide Description A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL).
Time Frame Weeks 48 and 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were missing=failure (M=F), switch included, TLOVR, Observed, and M/D=F
Arm/Group Title Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
Hide Arm/Group Description:
1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
Overall Number of Participants Analyzed 343 345
Measure Type: Number
Unit of Measure: percentage of participants
M=F, Switch Included, Week 48 75.2 71.3
TLOVR, Week 48 70.9 66.4
Obs, Week 48 93.8 92.2
M/D=F, Week 48 71.4 66.2
M=F, Switch Included, Week 96 63.9 61.2
TLOVR, Week 96 58.4 56.3
Obs, Week 96 92.8 96.3
M/D=F, Week 96 60.1 56.9
7.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
Hide Description A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA <100,000 copies/mL.
Time Frame Weeks 48 and 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were missing=failure (M=F), switch included, TLOVR, Observed, and M/D=F
Arm/Group Title Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
Hide Arm/Group Description:
1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
Overall Number of Participants Analyzed 188 205
Measure Type: Number
Unit of Measure: percentage of participants
M=F, Switch Included, Week 48 76 71
TLOVR, Week 48 72 66
Obs, Week 48 94 91
M/D=F, Week 48 72 65
M=F, Switch Included, Week 96 65 60
TLOVR, Week 96 60 55
Obs, Week 96 92 97
M/D=F, Week 96 61 56
8.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
Hide Description A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA >=100,000 copies/mL.
Time Frame Weeks 48 and 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were missing=failure (M=F), switch included, TLOVR, Observed, and M/D=F
Arm/Group Title Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
Hide Arm/Group Description:
1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
Overall Number of Participants Analyzed 155 140
Measure Type: Number
Unit of Measure: percentage of participants
M=F, Switch Included, Week 48 75 71
TLOVR, Week 48 70 67
Obs, Week 48 94 94
M/D=F, Week 48 71 68
M=F, Switch Included, Week 96 63 63
TLOVR, Week 96 56 58
Obs, Week 96 93 96
M/D=F, Week 96 59 58
9.Secondary Outcome
Title Median Change From Baseline in HIV-1 RNA at Week 48 and 96
Hide Description A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. Change from baseline was defined as HIV-1 RNA level at Weeks 48 and 96 minus HIV-1 RNA level at baseline.
Time Frame Weeks 48 and 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat-Exposed (ITT-E) population, observed analysis.
Arm/Group Title Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
Hide Arm/Group Description:
1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
Overall Number of Participants Analyzed 236 219
Median (Full Range)
Unit of Measure: log10 copies/mL
Week 48
-3.142
(-4.847 to 0.970)
-3.131
(-4.874 to 2.530)
Week 96
-3.114
(-5.304 to 0.819)
-3.165
(-4.874 to 0.139)
10.Secondary Outcome
Title Median Change From Baseline in CD4+ Cells at Weeks 48 and 96
Hide Description A blood sample was drawn to determine the CD4+ cell count at Weeks 48 and 96. Change from baseline was defined as CD4+ cell count at week 96 minus CD4+ cell count at baseline.
Time Frame Weeks 48 and 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat-Exposed (ITT-E) population, observed analysis.
Arm/Group Title Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
Hide Arm/Group Description:
1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
Overall Number of Participants Analyzed 234 218
Median (Full Range)
Unit of Measure: cells per cmm
Week 48
201.0
(-170 to 903)
173.0
(-190 to 921)
Week 96
250.0
(-226 to 1033)
246.5
(-116 to 793)
11.Secondary Outcome
Title Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96
Hide Description The number of participants that failed to respond to therapy based on the protocol definition of virologic failure (PDVF) was tabulated. PDVF was defined as either no confirmed HIV-1 RNA <200 copies/mL or HIV-1 RNA rebound >= 200 copies/mL on two consecutive occasions.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat-Exposed (ITT-E) population
Arm/Group Title Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
Hide Arm/Group Description:
1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
Overall Number of Participants Analyzed 343 345
Measure Type: Number
Unit of Measure: participants
Protocol-defined virologic failure 49 48
Fail to confirm HIV-1 RNA <200 copies/mL by wk 24 21 24
Confirmed HIV-1 RNA rebound to >= 200 copies/mL 28 24
Suspected HIV-1 RNA rebound to >= 200 copies/mL 12 11
12.Secondary Outcome
Title Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks
Hide Description A blood sample was drawn for participants failing to respond to therapy and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New mutations that developed at the time of failure was tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.
Time Frame Baseline and time of virologic failure (up to Week 96)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Intent-To-Treat-Exposed (ITT-E) population who met the confirmed virologic failure criteria with paired baseline and virologic failure genotypic evaluations
Arm/Group Title Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
Hide Arm/Group Description:
1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
Overall Number of Participants Analyzed 45 41
Measure Type: Number
Unit of Measure: participants
No. with paired genotypes at baseline and wk 96 45 41
Participants with treatment-emergent mutations 18 22
NRTI-associated mutations 11 17
NNRTI-associated mutations 4 3
PI-associated mutations 11 7
13.Secondary Outcome
Title Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility
Hide Description A blood sample was drawn for participants failing to respond to therapy and the mutations present in the virus were identified. New mutations that developed to the NRTI class at the time of failure that no longer responded to lamivudine or emtricitabine were tabulated by drug class.
Time Frame Baseline and time of virologic failure (up to Week 96)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the Intent-To-Treat-Exposed (ITT-E) population who met the confirmed virologic failure criteria and had the M184 mutations.
Arm/Group Title Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
Hide Arm/Group Description:
1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
Overall Number of Participants Analyzed 11 17
Measure Type: Number
Unit of Measure: participants
Resistance NRTI class (M184V, M/V,M/I,A/V,I,M/I/V) 11 17
Reduced pheno susceptibility to lamivudine/M184V 4 9
Reduced phen susceptibility to lamivudine/M184M/V 3 0
Reduced pheno susceptibility to lamivudine/M184M/I 0 1
Reduced pheno susceptibility to lamivudine/M184A/V 0 1
Reduced pheno susceptibility to lamivudine/M184I 0 1
Reduced pheno suscept. to lamivudine/M184M/I/V 0 1
Reduced pheno suscept. to emtricitabine/M184V 4 9
Reduced pheno suscept. to emtricitabine/M184M/V 3 0
Reduced pheno suscept. to emtricitabine/M184M/I 0 1
Reduced pheno suscept. to emtricitabine/M184A/V 0 1
Reduced pheno suscept. to emtricitabine/M184I 0 1
Reduced pheno suscept. to emtricitabine/M184M/I/V 0 1
14.Secondary Outcome
Title Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction
Hide Description The number of participants that experienced symptoms of a suspected abacavir hypersensitivity reaction was tabulated. The number of participants that developed laboratory signs of proximal renal tubule dysfunction was tabulated.
Time Frame Baseline through 96 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Safety population which included all randomized participants who received at least one dose of study medication.
Arm/Group Title Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
Hide Arm/Group Description:
1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
Overall Number of Participants Analyzed 343 345
Measure Type: Number
Unit of Measure: participants
Participants (Par.) with suspected ABC HSR 14 3
Mild or Grade 1 1 0
Moderate or Grade 2 8 2
Severe or Grade 3 4 1
Not Applicable 1 0
Par. with proximal renal tubule dysfunction 0 5
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
Hide Arm/Group Description 1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily 1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
All-Cause Mortality
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
Affected / at Risk (%) Affected / at Risk (%)
Total   42   45 
Blood and lymphatic system disorders     
Anaemia  1  2/343 (0.58%)  2/345 (0.58%) 
Cardiac disorders     
Cardiac arrest  1  0/343 (0.00%)  1/345 (0.29%) 
Cardiac failure congestive  1  0/343 (0.00%)  1/345 (0.29%) 
Cardiopulmonary failure  1  0/343 (0.00%)  1/345 (0.29%) 
Endocrine disorders     
Adrenal insufficiency  1  1/343 (0.29%)  0/345 (0.00%) 
Eye disorders     
Diabetic retinopathy  1  0/343 (0.00%)  1/345 (0.29%) 
Gastrointestinal disorders     
Haematemesis  1  1/343 (0.29%)  1/345 (0.29%) 
Nausea  1  0/343 (0.00%)  2/345 (0.58%) 
Ascites  1  0/343 (0.00%)  1/345 (0.29%) 
Diarrhoea  1  0/343 (0.00%)  1/345 (0.29%) 
Gastrointestinal haemorrhage  1  0/343 (0.00%)  1/345 (0.29%) 
Haemorrhoids  1  1/343 (0.29%)  0/345 (0.00%) 
Proctitis  1  1/343 (0.29%)  0/345 (0.00%) 
Vomiting  1  0/343 (0.00%)  1/345 (0.29%) 
General disorders     
Chest pain  1  2/343 (0.58%)  0/345 (0.00%) 
Pyrexia  1  1/343 (0.29%)  1/345 (0.29%) 
Death  1  0/343 (0.00%)  1/345 (0.29%) 
Gait disturbance  1  1/343 (0.29%)  0/345 (0.00%) 
Non-cardiac chest pain  1  0/343 (0.00%)  1/345 (0.29%) 
Hepatobiliary disorders     
Cholecystitis acute  1  1/343 (0.29%)  0/345 (0.00%) 
Hepatitic cirrhosis  1  0/343 (0.00%)  1/345 (0.29%) 
Hepatosplenomegaly  1  0/343 (0.00%)  1/345 (0.29%) 
Hepatotoxicity  1  1/343 (0.29%)  0/345 (0.00%) 
Immune system disorders     
Drug hypersensitivity  1  12/343 (3.50%)  3/345 (0.87%) 
Hypersensitivity  1  2/343 (0.58%)  0/345 (0.00%) 
Immune reconstitution syndrome  1  2/343 (0.58%)  0/345 (0.00%) 
Infections and infestations     
Pneumonia  1  3/343 (0.87%)  4/345 (1.16%) 
Gastroenteritis  1  1/343 (0.29%)  1/345 (0.29%) 
Meningitis cryptococcal  1  1/343 (0.29%)  1/345 (0.29%) 
Mycobacterium avium complex infection  1  0/343 (0.00%)  2/345 (0.58%) 
Pneumocystis jiroveci pneumonia  1  1/343 (0.29%)  1/345 (0.29%) 
Staphylococcal infection  1  1/343 (0.29%)  1/345 (0.29%) 
Abscess  1  0/343 (0.00%)  1/345 (0.29%) 
Abscess limb  1  1/343 (0.29%)  0/345 (0.00%) 
Bronchitis  1  0/343 (0.00%)  1/345 (0.29%) 
Cellulitis  1  0/343 (0.00%)  1/345 (0.29%) 
Cryptococcal fungaemia  1  1/343 (0.29%)  0/345 (0.00%) 
Encephalitis viral  1  0/343 (0.00%)  1/345 (0.29%) 
Gastroenteritis viral  1  1/343 (0.29%)  0/345 (0.00%) 
Helicobacter infection  1  0/343 (0.00%)  1/345 (0.29%) 
Kidney infection  1  1/343 (0.29%)  0/345 (0.00%) 
Meningitis viral  1  1/343 (0.29%)  0/345 (0.00%) 
Perianal abscess  1  1/343 (0.29%)  0/345 (0.00%) 
Perirectal abscess  1  0/343 (0.00%)  1/345 (0.29%) 
Pharyngitis streptococcal  1  1/343 (0.29%)  0/345 (0.00%) 
Pneumonia bacterial  1  0/343 (0.00%)  1/345 (0.29%) 
Progressive multifocal leukoencephalopathy  1  0/343 (0.00%)  1/345 (0.29%) 
Sepsis  1  0/343 (0.00%)  1/345 (0.29%) 
Staphylococcal bacteraemia  1  0/343 (0.00%)  1/345 (0.29%) 
Tonsilitis streptococcal  1  1/343 (0.29%)  0/345 (0.00%) 
Tuberculosis  1  1/343 (0.29%)  0/345 (0.00%) 
Upper respiratory tract infection  1  0/343 (0.00%)  1/345 (0.29%) 
Injury, poisoning and procedural complications     
Concussion  1  0/343 (0.00%)  1/345 (0.29%) 
Fall  1  1/343 (0.29%)  0/345 (0.00%) 
Head injury  1  1/343 (0.29%)  0/345 (0.00%) 
Laceration  1  0/343 (0.00%)  1/345 (0.29%) 
Investigations     
Creatinine renal clearance decreased  1  0/343 (0.00%)  1/345 (0.29%) 
Metabolism and nutrition disorders     
Dehydration  1  1/343 (0.29%)  0/345 (0.00%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion  1  1/343 (0.29%)  1/345 (0.29%) 
Back pain  1  0/343 (0.00%)  1/345 (0.29%) 
Lumbar spinal stenosis  1  0/343 (0.00%)  1/345 (0.29%) 
Tendon pain  1  1/343 (0.29%)  0/345 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Kaposi’s sarcoma  1  2/343 (0.58%)  0/345 (0.00%) 
Carcinoid tumor  1  0/343 (0.00%)  1/345 (0.29%) 
Hodgkin’s disease  1  0/343 (0.00%)  1/345 (0.29%) 
Malignant melanoma in situ  1  1/343 (0.29%)  0/345 (0.00%) 
Non-Hodgkin’s lymphoma  1  0/343 (0.00%)  1/345 (0.29%) 
Renal cell carcinoma  1  1/343 (0.29%)  0/345 (0.00%) 
Nervous system disorders     
Transient ischaemic attack  1  1/343 (0.29%)  1/345 (0.29%) 
Balance disorder  1  0/343 (0.00%)  1/345 (0.29%) 
Brain mass  1  1/343 (0.29%)  0/345 (0.00%) 
Brain stem infarction  1  0/343 (0.00%)  1/345 (0.29%) 
Cerebrovascular accident  1  0/343 (0.00%)  1/345 (0.29%) 
Migraine  1  0/343 (0.00%)  1/345 (0.29%) 
Syncope  1  0/343 (0.00%)  1/345 (0.29%) 
Pregnancy, puerperium and perinatal conditions     
Ectopic pregnancy  1  0/343 (0.00%)  1/345 (0.29%) 
Psychiatric disorders     
Dependence  1  0/343 (0.00%)  1/345 (0.29%) 
Depression  1  1/343 (0.29%)  0/345 (0.00%) 
Major depression  1  0/343 (0.00%)  1/345 (0.29%) 
Mental status changes  1  0/343 (0.00%)  1/345 (0.29%) 
Suicide attempt  1  0/343 (0.00%)  1/345 (0.29%) 
Renal and urinary disorders     
Haematuria  1  0/343 (0.00%)  1/345 (0.29%) 
Renal failure  1  0/343 (0.00%)  1/345 (0.29%) 
Renal failure acute  1  0/343 (0.00%)  1/345 (0.29%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1  1/343 (0.29%)  2/345 (0.58%) 
Bronchial hyperreactivity  1  1/343 (0.29%)  0/345 (0.00%) 
Chronic obstructive pulmonary disease  1  1/343 (0.29%)  0/345 (0.00%) 
Respiratory failure  1  0/343 (0.00%)  1/345 (0.29%) 
Skin and subcutaneous tissue disorders     
Ecchymosis  1  0/343 (0.00%)  1/345 (0.29%) 
Surgical and medical procedures     
Debridement  1  1/343 (0.29%)  0/345 (0.00%) 
Vascular disorders     
Deep vein thrombosis  1  0/343 (0.00%)  2/345 (0.58%) 
Hypertension  1  0/343 (0.00%)  1/345 (0.29%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
Affected / at Risk (%) Affected / at Risk (%)
Total   182   182 
Gastrointestinal disorders     
Diarrhoea  1  85/343 (24.78%)  80/345 (23.19%) 
Nausea  1  33/343 (9.62%)  28/345 (8.12%) 
Vomiting  1  21/343 (6.12%)  15/345 (4.35%) 
General disorders     
Fatigue  1  21/343 (6.12%)  13/345 (3.77%) 
Infections and infestations     
Upper respiratory tract infection  1  25/343 (7.29%)  31/345 (8.99%) 
Sinusitis  1  19/343 (5.54%)  24/345 (6.96%) 
Investigations     
Blood triglycerides increased  1  31/343 (9.04%)  26/345 (7.54%) 
Glomerular filtration rate decreased  1  21/343 (6.12%)  28/345 (8.12%) 
Blood cholesterol increased  1  27/343 (7.87%)  20/345 (5.80%) 
Nervous system disorders     
Headache  1  25/343 (7.29%)  23/345 (6.67%) 
Psychiatric disorders     
Depression  1  25/343 (7.29%)  23/345 (6.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00244712     History of Changes
Other Study ID Numbers: EPZ104057
EPZ104057
First Submitted: October 25, 2005
First Posted: October 27, 2005
Results First Submitted: April 23, 2009
Results First Posted: September 15, 2009
Last Update Posted: June 8, 2010