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KIVEXA Vs TRUVADA, Both Administered With Efavirenz, In ART-Naive Subjects (ASSERT)

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ClinicalTrials.gov Identifier: NCT00549198
Recruitment Status : Completed
First Posted : October 25, 2007
Results First Posted : October 15, 2010
Last Update Posted : April 12, 2011
Sponsor:
Information provided by:
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Infection, Human Immunodeficiency Virus I
HIV Infection
Interventions Drug: Abacavir/lamivudine and efavirenz
Drug: Tenofovir/Emtricitabine and efavirenz
Enrollment 392
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Period Title: Overall Study
Started 195 [1] 197 [2]
Completed 115 134
Not Completed 80 63
Reason Not Completed
Adverse Event             28             26
Insufficient Viral Load Response             4             2
Protocol-defined Virological Failure             7             0
Non-compliance             2             4
Lost to Follow-up             7             8
Treatment Eligibility Criteria Not Met             3             0
Protocol Violation             7             2
Investigator Decision             4             3
Withdrawal by Subject             7             7
Disease Progression             1             0
Participant Moved             2             0
Participant not able to perform Week 96             1             0
Participant moved.Week 96 visit, no scan             1             0
Prohibited Medication             1             2
Participant planning pregnancy             1             0
Participant overweight, no scan possible             1             0
No scan facilities             0             2
Pregnancy             0             3
Not Exposed to Study Drug             3             4
[1]
Three participants were randomized but were not exposed to study drug (ABC/3TC).
[2]
Four participants were randomized but were not exposed to study drug (TDF/FTC).
Arm/Group Title ABC/3TC FDC TDF/FTC FDC Total
Hide Arm/Group Description Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD Total of all reporting groups
Overall Number of Baseline Participants 192 193 385
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Median (Full Range)
Unit of measure:  Years
Number Analyzed 192 participants 193 participants 385 participants
38.0
(19 to 70)
36.0
(18 to 66)
37.0
(18 to 70)
[1]
Measure Description: The Intent-to-Treat (ITT)-Exposed (E) Population, comprised of all randomized participants who received at least one dose of study medication, was used for all baseline characteristics.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 192 participants 193 participants 385 participants
Female
33
  17.2%
40
  20.7%
73
  19.0%
Male
159
  82.8%
153
  79.3%
312
  81.0%
[1]
Measure Description: The Intent-to-Treat (ITT)-Exposed (E) Population, comprised of all randomized participants who received at least one dose of study medication, was used for all baseline characteristics.
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 192 participants 193 participants 385 participants
African American/African Heritage 26 30 56
American Indian or Alaska Native 11 7 18
Asian 2 5 7
White 153 151 304
[1]
Measure Description: The Intent-to-Treat (ITT)-Exposed (E) Population, comprised of all randomized participants who received at least one dose of study medication, was used for all baseline characteristics.
1.Primary Outcome
Title Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 48
Hide Description Change from baseline was calculated as the Week 48 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine; BMI, body mass index.
Time Frame Baseline, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat-Exposed (ITT-E) Population: all randomized participants who received at least one dose of study medication
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 192 193
Mean (Standard Error)
Unit of Measure: milliliters per minute (mL/min)/1.73 m^2
0.22  (0.890) 1.18  (0.828)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC/3TC FDC, TDF/FTC FDC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.435
Comments The model includes the following covariates: treatment, visit, baseline GFR by MDRD, baseline BMI, race group, treatment*visit, baseline GFR by MDRD*visit and baseline BMI*visit.
Method Mixed Models Analysis
Comments The correlation matrix for within-subject errors is unstructured.
2.Secondary Outcome
Title Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 24
Hide Description Change from baseline was calculated as the Week 24 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 192 193
Mean (Standard Error)
Unit of Measure: mL/min/1.73m^2
2.78  (0.884) 0.43  (0.842)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC/3TC FDC, TDF/FTC FDC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.057
Comments The model includes the following covariates: treatment, visit, baseline GFR by MDRD, baseline BMI, race group, age group, treatment*visit, baseline GFR by MDRD*visit and baseline BMI*visit.
Method Mixed Models Analysis
Comments The correlation matrix for within-subject errors is unstructured.
3.Secondary Outcome
Title Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 96
Hide Description Change from baseline was calculated as the Week 96 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^s, meters squared; Scr, serum creatinine.
Time Frame Baseline, Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 192 193
Mean (Standard Error)
Unit of Measure: mL/min/1.73m^2
1.48  (1.022) -1.15  (0.944)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC/3TC FDC, TDF/FTC FDC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.060
Comments The model includes the following covariates: treatment, visit, baseline GFR by MDRD, baseline BMI, race group, treatment*visit, baseline GFR by MDRD*visit and baseline BMI*visit.
Method Mixed Models Analysis
Comments The correlation matrix for within-subject errors is unstructured.
4.Secondary Outcome
Title Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 24
Hide Description Change from baseline was calculated as the Week 24 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram; CG, Cockcroft-Gault.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 192 193
Mean (Standard Error)
Unit of Measure: mL/min
4.27  (0.944) 2.54  (0.897)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC/3TC FDC, TDF/FTC FDC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.186
Comments The model includes the following covariates: treatment, visit, baseline GFR by CG, baseline BMI, race group, age group, hypertension, treatment*visit, baseline GFR by CG*visit and baseline BMI*visit.
Method Mixed Models Analysis
Comments The correlation matrix for within-subject errors is unstructured.
5.Secondary Outcome
Title Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 48
Hide Description Change from baseline was calculated as the Week 48 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram.
Time Frame Baseline, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 192 193
Mean (Standard Error)
Unit of Measure: mL/min
2.66  (1.005) 3.80  (0.933)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC/3TC FDC, TDF/FTC FDC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.413
Comments The model includes the following covariates: treatment, visit, baseline GFR by CG, baseline BMI, race group, age group, hypertension, treatment*visit, baseline GFR by CG*visit and baseline BMI*visit.
Method Mixed Models Analysis
Comments The correlation matrix for within-subject errors is unstructured.
6.Secondary Outcome
Title Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 96
Hide Description Change from baseline was calculated as the Week 96 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram.
Time Frame Baseline, Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 192 193
Mean (Standard Error)
Unit of Measure: mL/min
4.37  (1.228) 2.68  (1.133)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC/3TC FDC, TDF/FTC FDC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.315
Comments The model includes the following covariates: treatment, visit, baseline GFR by CG, baseline BMI, race group, baseline CD4, treatment*visit, baseline GFR by CG*visit, baseline BMI*visit and baseline CD4*visit.
Method Mixed Models Analysis
Comments The correlation matrix for within-subject errors is unstructured.
7.Secondary Outcome
Title Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24
Hide Description mL, milliliter; min, minute; m^2, meters squared
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Some participants had withdrawn from the study by Week 24.
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 156 173
Measure Type: Number
Unit of Measure: participants
>=10 mL/min, MDRD 16 26
>=10 mL/min, Cockcroft-Gault 16 20
>=20 mL/min, MDRD 4 6
>=20 mL/min, Cockcroft-Gault 3 4
>=10%, MDRD 15 24
>=10%, Cockcroft-Gault 10 17
>=20%, MDRD 2 3
>=20%, Cockcroft-Gault 2 3
8.Secondary Outcome
Title Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48
Hide Description mL, milliliter; min, minute; m^2, meters squared
Time Frame Baseline, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Some participants had withdrawn by Week 48.
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 136 159
Measure Type: Number
Unit of Measure: participants
>=10 mL/min, MDRD 23 21
>=10 mL/min, Cockcroft-Gault 15 14
>=20 mL/min, MDRD 4 3
>=20 mL/min, Cockcroft-Gault 4 2
>=10%, MDRD 21 21
>=10%, Cockcroft-Gault 11 9
>=20%, MDRD 4 2
>=20%, Cockcroft-Gault 3 0
9.Secondary Outcome
Title Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96
Hide Description mL, milliliter; min, minute; m^2, meters squared
Time Frame Baseline, Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Some participants had withdrawn by Week 96.
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 111 131
Measure Type: Number
Unit of Measure: participants
>=10 mL/min, MDRD 15 38
>=10 mL/min, Cockcroft-Gault 11 19
>=20 mL/min, MDRD 4 7
>=20 mL/min, Cockcroft-Gault 4 5
>=10%, MDRD 15 27
>=10%, Cockcroft-Gault 12 16
>=20%, MDRD 3 6
>=20%, Cockcroft-Gault 3 4
10.Secondary Outcome
Title Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24
Hide Description Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Some participants had withdrawn by Week 24.
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 114 135
Measure Type: Number
Unit of Measure: participants
Normal 97 114
Stage 1 11 15
Stage 2 5 5
Stage 3 1 1
Stage 4 0 0
Stage 5 0 0
11.Secondary Outcome
Title Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48
Hide Description Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram.
Time Frame Baseline, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Some participants had withdrawn by Week 48.
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 112 133
Measure Type: Number
Unit of Measure: participants
Missing 12 19
Normal 90 106
Stage 1 7 5
Stage 2 3 3
Stage 3 0 0
Stage 4 0 0
Stage 5 0 0
12.Secondary Outcome
Title Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96
Hide Description Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram.
Time Frame Baseline, Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Some participants had withdrawn by Week 96.
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 93 109
Measure Type: Number
Unit of Measure: participants
Missing 11 18
Normal 75 83
Stage 1 3 4
Stage 2 4 4
Stage 3 0 0
Stage 4 0 0
Stage 5 0 0
13.Secondary Outcome
Title Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24
Hide Description BMD is a measure (grams [g] per centimeters cubed [cm^3]) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 192 193
Mean (Standard Error)
Unit of Measure: percent change
-2.12  (0.0011) -3.30  (0.0011)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC/3TC FDC, TDF/FTC FDC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The model includes the following covariates: treatment, visit, baseline spine BMD, baseline BMI, race group, age group, hypertension, treatment*visit, baseline spine BMD*visit and baseline BMI*visit.
Method Mixed Models Analysis
Comments The correlation matrix for within-subject errors is unstructured.
14.Secondary Outcome
Title Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24
Hide Description BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 192 193
Mean (Standard Error)
Unit of Measure: percent change
-1.19  (0.0007) -2.73  (0.0007)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC/3TC FDC, TDF/FTC FDC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The model includes the following covariates: treatment, visit, baseline hip BMD, baseline BMI, race group, risk factor, country group, treatment*visit, baseline hip BMD*visit and baseline BMI*visit.
Method Mixed Models Analysis
Comments The correlation matrix for within-subject errors is unstructured.
15.Secondary Outcome
Title Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48
Hide Description BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.
Time Frame Baseline, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 192 193
Mean (Standard Error)
Unit of Measure: percent change
-1.59  (0.0013) -2.41  (0.0012)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC/3TC FDC, TDF/FTC FDC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.036
Comments The model includes the following covariates: treatment, visit, baseline spine BMD, baseline BMI, race group, age group, treatment*visit, baseline spine BMD*visit and baseline BMI*visit.
Method Mixed Models Analysis
Comments The correlation matrix for within-subject errors is unstructured.
16.Secondary Outcome
Title Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48
Hide Description BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.
Time Frame Baseline, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 192 193
Mean (Standard Error)
Unit of Measure: percent change
-1.90  (0.0010) -3.56  (0.0009)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC/3TC FDC, TDF/FTC FDC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The model includes the following covariates: treatment, visit, baseline hip BMD, baseline BMI, race group, risk factor, prohibited medication, previous fracture, treatment*visit, baseline hip BMD*visit and baseline BMI*visit.
Method Mixed Models Analysis
Comments Correlation matrix for within-subject errors is unstructured.
17.Secondary Outcome
Title Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96
Hide Description BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.
Time Frame Baseline, Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 192 193
Mean (Standard Error)
Unit of Measure: percent change
-0.87  (0.0017) -1.70  (0.0015)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC/3TC FDC, TDF/FTC FDC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.112
Comments The model includes the following covariates: treatment, visit, baseline spine BMD, baseline BMI, race group, age group, treatment*visit, baseline spine BMD*visit and baseline BMI*visit.
Method Mixed Models Analysis
Comments correlation matrix for within-subject errors is unstructured.
18.Secondary Outcome
Title Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96
Hide Description BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale.
Time Frame Baseline, Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 192 193
Mean (Standard Error)
Unit of Measure: percent change
-2.17  (0.0013) -3.55  (0.0012)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC/3TC FDC, TDF/FTC FDC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The model includes the following covariates: treatment, visit, baseline hip BMD, baseline BMI, race group, risk factor, prohibited medication, previous fracture, treatment*visit, baseline hip BMD*visit, and baseline BMI*visit.
Method Mixed Models Analysis
Comments The correlation matrix for within-subject errors is unstructured.
19.Secondary Outcome
Title Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 24
Hide Description BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Some participants had withdrawn by Week 24/did not have a DXA scan performed. DXA, dual energy x-ray absorptiometry.
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 142 165
Measure Type: Number
Unit of Measure: participants
>=2%, spine, n=142, 165 73 115
>=6%, spine, n=142, 165 10 17
>=2%, hip, n=137, 160 38 93
>=6%, hip, n=137, 160 1 6
20.Secondary Outcome
Title Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 48
Hide Description BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones.
Time Frame Baseline, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Some participants had withdrawn by Week 48/did not have a DXA scan performed. DXA, dual energy x-ray absorptiometry.
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 125 141
Measure Type: Number
Unit of Measure: participants
>=2%, spine, n=125, 141 51 84
>=6%, spine, n=125, 141 5 13
>=2%, hip, n=119, 140 54 111
>=6%, hip, n=119, 140 3 17
21.Secondary Outcome
Title Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 96
Hide Description BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones.
Time Frame Baseline, Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Some participants had withdrawn by Week 96/did not have a DXA scan performed. DXA, dual energy x-ray absorptiometry.
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 59 79
Measure Type: Number
Unit of Measure: participants
>=2%, spine, n=59, 79 21 39
>=6%, spine, n=59, 79 3 8
>=2%, hip, n=58, 76 33 52
>=6%, hip, n=58, 76 1 13
22.Secondary Outcome
Title Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 24
Hide Description The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a "normal, healthy, 30-year-old female". The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Some participants had withdrawn by Week 24.
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 149 173
Measure Type: Number
Unit of Measure: participants
Osteopenia, spine, n=147, 173 41 68
Osteporosis, spine, n=147, 173 16 9
Osteopenia, hip, n=149, 170 38 54
Osteoporosis, hip, n=149, 170 4 1
23.Secondary Outcome
Title Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 48
Hide Description The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a "normal, healthy, 30-year-old female". The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Some participants had withdrawn by Week 48.
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 132 147
Measure Type: Number
Unit of Measure: participants
Osteopenia, spine, n=132, 147 41 57
Osteporosis, spine, n=132, 147 15 5
Osteopenia, hip, n=130, 147 37 50
Osteoporosis, hip, n=130, 147 4 0
24.Secondary Outcome
Title Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 96
Hide Description The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a "normal, healthy, 30-year-old female". The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD.
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Some participants had withdrawn by Week 96.
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 65 82
Measure Type: Number
Unit of Measure: participants
Osteopenia, spine, n=64, 82 21 34
Osteporosis, spine, n=64, 82 5 3
Osteopenia, hip, n=65, 80 20 31
Osteoporosis, hip, n=65, 80 0 0
25.Secondary Outcome
Title Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24
Hide Description An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented.
Time Frame Baseline to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all randomized participants who received at least one dose of study medication
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 192 193
Measure Type: Number
Unit of Measure: participants
Any event 26 14
Drug hypersensitivity 11 1
Rash 2 3
Dizziness 0 2
Hypersensitivity 3 0
Drug eruption 1 1
26.Secondary Outcome
Title Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48
Hide Description An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented.
Time Frame Baseline to Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all randomized participants who received at least one dose of study medication
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 192 193
Measure Type: Number
Unit of Measure: participants
Any event 29 21
Drug hypersensitivity 11 1
Bone density decreased 0 2
Rash 2 3
Dizziness 1 3
Hypersensitivity 3 0
Drug eruption 1 1
27.Secondary Outcome
Title Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96
Hide Description An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all randomized participants who received at least one dose of study medication
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 192 193
Measure Type: Number
Unit of Measure: participants
Any event 33 28
Drug hypersensitivity 11 1
Bone density decreased 0 8
Rash 2 3
Dizziness 1 3
Hypersensitivity 3 0
Abnormal dreams 3 0
Drug eruption 1 1
Depression 0 2
28.Secondary Outcome
Title Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24
Hide Description Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 192 193
Measure Type: Number
Unit of Measure: participants
Desirable to desirable 54 104
Desirable to borderline high 47 29
Desirable to high 32 9
Borderline high to desirable 1 3
Borderline high to borderline high 2 9
Borderline high to high 10 6
High to desirable 0 0
High to borderline high 0 0
High to high 3 2
29.Secondary Outcome
Title Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48
Hide Description Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter.
Time Frame Baseline, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 192 193
Measure Type: Number
Unit of Measure: participants
Desirable to desirable 46 96
Desirable to borderline high 52 37
Desirable to high 36 9
Borderline high to desirable 1 1
Borderline high to borderline high 2 9
Borderline high to high 10 8
High to desirable 0 0
High to borderline high 0 0
High to high 3 2
30.Secondary Outcome
Title Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96
Hide Description Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter.
Time Frame Baseline, Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 192 193
Measure Type: Number
Unit of Measure: participants
Desirable to desirable 39 86
Desirable to borderline high 49 47
Desirable to high 46 10
Borderline high to desirable 1 1
Borderline high to borderline high 2 9
Borderline high to high 10 8
High to desirable 0 0
High to borderline high 0 0
High to high 3 2
31.Secondary Outcome
Title Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24
Hide Description Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 192 193
Measure Type: Number
Unit of Measure: participants
Optimal to optimal 22 46
Optimal to near or above optimal 41 43
Optimal to borderline high 22 11
Optimal to high 6 1
Optimal to very high 1 0
Near or above optimal to optimal 0 5
Near or above optimal to near or above optimal 6 22
Near or above optimal to borderline high 17 11
Near or above optimal to high 12 5
Near or above optimal to very high 4 1
Borderline high to optimal 0 0
Borderline high to near or above optimal 1 6
Borderline high to borderline high 2 3
Borderline high to high 4 3
Borderline high to very high 3 2
High to optimal 0 0
High to near or above optimal 0 0
High to borderline high 0 0
High to high 1 1
High to very high 0 0
Very high to optimal 0 0
Very high to near or above optimal 0 0
Very high to borderline high 1 0
Very high to high 0 0
Very high to very high 1 1
32.Secondary Outcome
Title Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48
Hide Description Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high.
Time Frame Baseline, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 192 193
Measure Type: Number
Unit of Measure: participants
Optimal to optimal 20 42
Optimal to near or above optimal 38 46
Optimal to borderline high 27 12
Optimal to high 8 1
Optimal to very high 1 0
Near or above optimal to optimal 0 3
Near or above optimal to near or above optimal 4 21
Near or above optimal to borderline high 19 13
Near or above optimal to high 12 6
Near or above optimal to very high 4 1
Borderline high to optimal 0 0
Borderline high to near or above optimal 1 3
Borderline high to borderline high 2 5
Borderline high to high 3 4
Borderline high to very high 4 2
High to optimal 0 0
High to near or above optimal 0 0
High to borderline high 0 0
High to high 1 1
High to very high 0 0
Very high to optimal 0 0
Very high to near or above optimal 0 0
Very high to borderline high 1 0
Very high to high 0 0
Very high to very high 1 1
33.Secondary Outcome
Title Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96
Hide Description Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high.
Time Frame Baseline, Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 192 193
Measure Type: Number
Unit of Measure: participants
Optimal to optimal 18 37
Optimal to near or above optimal 35 46
Optimal to borderline high 29 17
Optimal to high 9 1
Optimal to very high 3 0
Near or above optimal to optimal 0 1
Near or above optimal to near or above optimal 4 19
Near or above optimal to borderline high 17 16
Near or above optimal to high 12 7
Near or above optimal to very high 6 2
Borderline high to optimal 0 0
Borderline high to near or above optimal 1 3
Borderline high to borderline high 2 5
Borderline high to high 3 3
Borderline high to very high 4 3
High to optimal 0 0
High to near or above optimal 0 0
High to borderline high 0 0
High to high 1 1
High to very high 0 0
Very high to optimal 0 0
Very high to near or above optimal 0 0
Very high to borderline high 1 0
Very high to high 0 0
Very high to very high 1 1
34.Secondary Outcome
Title Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24
Hide Description Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 192 193
Measure Type: Number
Unit of Measure: participants
Low to low 19 36
Low to normal 72 66
Low to high 10 9
Normal to low 0 1
Normal to normal 12 30
Normal to high 26 12
High to low 0 0
High to normal 0 3
High to high 10 5
35.Secondary Outcome
Title Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48
Hide Description Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high.
Time Frame Baseline, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 192 193
Measure Type: Number
Unit of Measure: participants
Low to low 17 28
Low to normal 67 73
Low to high 18 10
Normal to low 0 0
Normal to normal 11 23
Normal to high 27 20
High to low 0 0
High to normal 0 3
High to high 10 5
36.Secondary Outcome
Title Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96
Hide Description Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high.
Time Frame Baseline, Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 192 193
Measure Type: Number
Unit of Measure: participants
Low to low 11 23
Low to normal 66 75
Low to high 25 13
Normal to low 0 0
Normal to normal 8 17
Normal to high 30 27
High to low 0 0
High to normal 0 1
High to high 10 7
37.Secondary Outcome
Title Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24
Hide Description Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150-<200 mg/dL, borderline high; 200-<500 mg/dL, high; >=500 mg/dL, very high.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 192 193
Measure Type: Number
Unit of Measure: participants
Normal to normal 63 78
Normal to borderline high 21 19
Normal to high 23 9
Normal to very high 0 0
Borderline high to normal 5 7
Borderline high to borderline high 5 10
Borderline high to high 9 15
Borderline high to very high 0 0
High to normal 2 6
High to borderline high 5 3
High to high 12 15
High to very high 3 0
Very high to normal 0 0
Very high to borderline high 0 0
Very high to high 0 1
Very high to very high 1 0
38.Secondary Outcome
Title Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48
Hide Description Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150-<200 mg/dL, borderline high; 200-<500 mg/dL, high; >=500 mg/dL, very high.
Time Frame Baseline, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 192 193
Measure Type: Number
Unit of Measure: participants
Normal to normal 55 70
Normal to borderline high 22 23
Normal to high 30 12
Normal to very high 0 1
Borderline high to normal 4 6
Borderline high to borderline high 5 7
Borderline high to high 11 19
Borderline high to very high 0 0
High to normal 2 5
High to borderline high 4 3
High to high 12 15
High to very high 4 0
Very high to normal 0 0
Very high to borderline high 0 0
Very high to high 0 1
Very high to very high 1 0
39.Secondary Outcome
Title Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96
Hide Description Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150->200 mg/dL, borderline high; 200-<500 mg/dL, high;>= 500 mg/dL, very high.
Time Frame Baseline, Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 192 193
Measure Type: Number
Unit of Measure: participants
Normal to normal 47 55
Normal to borderline high 25 31
Normal to high 34 20
Normal to very high 1 1
Borderline high to normal 4 5
Borderline high to borderline high 4 8
Borderline high to high 11 19
Borderline high to very high 1 0
High to normal 2 5
High to borderline high 4 2
High to high 11 16
High to very high 5 0
Very high to normal 0 0
Very high to borderline high 0 0
Very high to high 0 1
Very high to very high 1 0
40.Secondary Outcome
Title Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24
Hide Description The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug treatment.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 192 193
Measure Type: Number
Unit of Measure: participants
Cholesterol, Grade 3 6 1
Cholesterol, Grade 4 0 0
LDL cholesterol, Grade 3 8 3
LDL cholesterol, Grade 4 0 0
Non-HDL cholesterol, Grade 3 19 5
Non-HDL cholesterol, Grade 4 0 0
Triglycerides, Grade 3 2 0
Triglycerides, Grade 4 0 0
Alanine aminotransferase, Grade 3 1 3
Alanine aminotransferase, Grade 4 1 1
Aspartate aminotransferase, Grade 3 1 0
Aspartate aminotransferase, Grade 4 1 2
Alkaline phosphatase, Grade 3 0 1
Alkaline phosphatase, Grade 4 0 0
Creatinine kinase, Grade 3 0 1
Creatinine kinase, Grade 4 1 1
Phosphorus inorganic, Grade 3 1 1
Phosphorus inorganic, Grade 4 0 0
Lipase, Grade 3 3 1
Lipase, Grade 4 2 0
Hyperkalaemia, Grade 3 0 0
Hyperkalaemia, Grade 4 1 1
Glomerular filtration rate, MDRD, Grade 3 1 1
Glomerular filtration rate, MDRD, Grade 4 0 0
Total neutrophils, Grade 3 1 0
Total neutrophils, Grade 4 1 2
Thrombocytopenia, Grade 3 1 0
Thrombocytopenia, Grade 4 0 0
41.Secondary Outcome
Title Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48
Hide Description The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug treatment.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 192 193
Measure Type: Number
Unit of Measure: participants
Cholesterol, Grade 3 7 1
Cholesterol, Grade 4 0 0
LDL cholesterol, Grade 3 9 3
LDL cholesterol, Grade 4 0 0
Non-HDL cholesterol, Grade 3 20 6
Non-HDL cholesterol, Grade 4 0 0
Triglycerides, Grade 3 3 0
Triglycerides, Grade 4 0 0
Alanine aminotransferase, Grade 3 2 4
Alanine aminotransferase, Grade 4 2 1
Aspartate aminotransferase, Grade 3 2 0
Aspartate aminotransferase, Grade 4 2 2
Alkaline phosphatase, Grade 3 0 1
Alkaline phosphatase, Grade 4 0 0
Total bilirubin Grade 3 1 0
Total bilirubin, Grade 4 0 0
Creatinine kinase, Grade 3 0 2
Creatinine kinase, Grade 4 1 1
Phosphorus inorganic, Grade 3 3 1
Phosphorus inorganic, Grade 4 0 0
Lipase, Grade 3 5 1
Lipase, Grade 4 2 0
Hyperkalaemia, Grade 3 0 0
Hyperkalaemia, Grade 4 2 2
Glomerular filtration rate, MDRD, Grade 3 1 1
Glomerular filtration rate, MDRD, Grade 4 0 0
Total neutrophils, Grade 3 2 0
Total neutrophils, Grade 4 3 2
Thrombocytopenia, Grade 4 1 0
Thrombocytopenia, Grade 4 0 0
42.Secondary Outcome
Title Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96
Hide Description The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug therapy.
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 192 193
Measure Type: Number
Unit of Measure: participants
Cholesterol, Grade 3 9 1
Cholesterol, Grade 4 0 0
LDL cholesterol, Grade 3 13 5
LDL cholesterol, Grade 4 0 0
Non-HDL cholesterol, Grade 3 22 5
Non-HDL cholesterol, Grade 4 0 0
Triglycerides, Grade 3 2 0
Triglycerides, Grade 4 1 0
Alanine aminotransferase, Grade 3 2 4
Alanine aminotransferase, Grade 4 2 1
Aspartate aminotransferase, Grade 3 2 1
Aspartate aminotransferase, Grade 4 2 2
Alkaline phosphatase, Grade 3 0 1
Alkaline phosphatase, Grade 4 0 0
Total bilirubin, Grade 3 1 0
Total bilirubin, Grade 4 0 0
Creatinine kinase, Grade 3 0 2
Creatinine kinase, Grade 4 1 2
Phosphorus inorganic, Grade 3 4 3
Phosphorus inorganic, Grade 4 0 0
Lipase, Grade 3 6 2
Lipase, Grade 4 4 2
Hyperkalaemia, Grade 3 0 0
Hyperkalaemia, Grade 4 2 0
Glomerular filtration rate, MDRD, Grade 3 1 1
Glomerular filtration rate, MDRD, Grade 4 0 0
Total neutrophils, Grade 3 3 1
Total neutrophils, Grade 4 5 3
Thrombocytopenia, Grade 3 1 0
Thrombocytopenia, Grade 4 0 0
43.Secondary Outcome
Title Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 24
Hide Description HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Failures and missing values are derived according to the Time to Loss of Virologic Response (TLOVR) Food and Drug Administration (FDA) algorithm.
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 192 193
Measure Type: Number
Unit of Measure: participants
<50 copies/mL 126 144
<400 copies/mL 147 168
44.Secondary Outcome
Title Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 48
Hide Description HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Failures and missing values are derived according to the Time to Loss of Virologic Response (TLOVR) Food and Drug Administration (FDA) algorithm.
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 192 193
Measure Type: Number
Unit of Measure: participants
<50 copies/mL 121 145
<400 copies/mL 130 151
45.Secondary Outcome
Title Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 96
Hide Description HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection.
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Failures and missing values are derived according to the Time to Loss of Virologic Response (TLOVR) Food and Drug Administration (FDA) algorithm.
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 192 193
Measure Type: Number
Unit of Measure: participants
<50 copies/mL 98 113
<400 copies/mL 110 126
46.Secondary Outcome
Title Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 24
Hide Description CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study.
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Some participants had withdrawn by Week 24.
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 153 172
Median (Inter-Quartile Range)
Unit of Measure: cells/millimeters cubed (mm^3)
110.0
(50.0 to 180.0)
100.0
(45.0 to 150.0)
47.Secondary Outcome
Title Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 48
Hide Description CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study.
Time Frame Baseline, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Some participants had withdrawn by Week 48.
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 136 156
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
150.0
(95.0 to 270.0)
150.0
(80.0 to 215.0)
48.Secondary Outcome
Title Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 96
Hide Description CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study.
Time Frame Baseline, Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. Some participants had withdrawn by Week 96.
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 110 128
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
235.0
(130.0 to 390.0)
220.0
(150.0 to 315.0)
49.Secondary Outcome
Title Number of Participants Classified as Protocol-defined Failures With Treatment-emergent Resistance to Study Drug in the Indicated Viruses at Week 96
Hide Description Viral resistance was measured using blood samples collected from participants throughout the study. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor. Virological failure was defined as any one of: participant does not achieve a 1 log10 copies (cop)/mL decrease in plasma HIV-1 RNA by Week (Wk) 4, or has two consecutive plasma HIV-1 RNA measures >=400 cop/mL separated by at least 2-4 wk after being previously <=400 cop/mL on/after Wk 4, or has two consecutive plasma HIV-1 RNA measures >400 cop/mL separated by at least 2-4 wk on/after Wk 24.
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
On-Treatment Resistance: all participants who fulfilled the definition of protocol-defined virological failure (VF) who had paired baseline and VF genotypic data for analysis. One ABC/3TC participant took prohibited medication that potentially lowered efavirenz levels just prior to VF, allowing for the emergence of unexpected NRTI resistance.
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 7 3
Measure Type: Number
Unit of Measure: participants
Any treatment-emergent mutation 4 0
NRTI 4 0
NNRTI 2 0
50.Secondary Outcome
Title Number of Participants Who Indicated "Yes" or "No" to the Question of Whether Unplanned Healthcare Resources Were Utilized
Hide Description Participants were asked at each visit whether or not they utilized unplanned healthcare resources.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT-E Population. The number of participants analyzed differed by visit because some had withdrawn during the study and some did not have an assessment performed.
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 178 183
Measure Type: Number
Unit of Measure: participants
Week 4, Yes, n=178, 183 60 49
Week 4, No, n=178, 183 118 134
Week 12, Yes, n=162, 177 56 47
Week 12, No, n=162, 177 106 130
Week 24, Yes, n=156, 173 70 59
Week 24, No, n=156, 173 86 114
Week 36, Yes, n=148, 169 48 50
Week 36, No, n=148, 169 100 119
Week 48, Yes, n=137, 161 44 36
Week 48, No, n=137, 161 93 125
Week 60, Yes, n=129, 148 47 44
Week 60, No, n=129, 148 82 104
Week 72, Yes, n=126, 139 48 40
Week 72, No, n=126, 139 78 99
Week 84, Yes, n=121, 136 34 24
Week 84, No, n=121, 136 87 108
Week 96, Yes, n=113, 135 30 17
Week 96, No, n=113, 135 83 118
51.Other Pre-specified Outcome
Title Exploratory Analysis of Change From Baseline in Albumin as a Ratio to Urine Creatinine at Week 96
Hide Description Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline albumin value by the urine creatinine value. Albumin is measured in milligrams per millimole (mg/mmol).
Time Frame Baseline, Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Biomarker Population: all randomized participants who received at least one dose of study medication and had at least one parameter measured at Baseline and at least one post-baseline visit. Some participants had withdrawn by Week 96.
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 103 120
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
0.872
(0.716 to 1.062)
0.973
(0.806 to 1.174)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC/3TC FDC, TDF/FTC FDC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3025
Comments The model includes the following covariates: treatment, age, baseline biomarker value, and gender.
Method ANOVA
Comments Estimates are calculated from an ANOVA model. Parameters are analyzed based on log transformed data.
52.Other Pre-specified Outcome
Title Exploratory Analysis of Change From Baseline in Beta 2 Microglobulin (B2M) as a Ratio to Urine Creatinine at Week 96
Hide Description Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline B2M value by the urine creatinine value. B2M, beta 2 microglobulin (measured in mg/mmol).
Time Frame Baseline, Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Some participants had withdrawn by Week 96.
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 87 105
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
0.542
(0.370 to 0.792)
0.984
(0.684 to 1.416)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC/3TC FDC, TDF/FTC FDC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The model includes the following covariates: treatment, age, baseline biomarker value, baseline CD4, and gender.
Method ANOVA
Comments Estimates are calculated from an ANOVA model. Parameters are analyzed based on log transformed data.
53.Other Pre-specified Outcome
Title Exploratory Analysis of Change From Baseline in N-acetyl-B-glucosaminidase (NAG) as a Ratio to Urine Creatinine at Week 96
Hide Description Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline NAG value by the urine creatinine value. NAG, N-acetyl-B-glucosaminidase (measured in micromoles per hour per millimole [umol/h/mmol]).
Time Frame Baseline, Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Biomarker Population: all randomized participants who received at least one dose of study medication and had at least one parameter measured at Baseline and at least one post-baseline visit. Some participants had withdrawn by Week 96.
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 103 120
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
0.868
(0.774 to 0.974)
0.939
(0.844 to 1.044)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC/3TC FDC, TDF/FTC FDC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3323
Comments The model includes the following covariates: treatment, age, and baseline biomarker value.
Method ANOVA
Comments Estimates are calculated from an ANOVA model. Parameters are analyzed based on log transformed data.
54.Other Pre-specified Outcome
Title Exploratory Analysis of Change From Baseline in Retinol Binding Protein (RBP) as a Ratio to Urine Creatinine at Week 96
Hide Description Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline RBP value by the urine creatinine value. RBP, retinol binding protein (measured in micrograms per millimole [ug/mmol]).
Time Frame Baseline, Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Biomarker Population: all randomized participants who received at least one dose of study medication and had at least one parameter measured at Baseline and at least one post-baseline visit. Some participants had withdrawn by Week 96.
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 103 120
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
1.099
(0.882 to 1.369)
1.550
(1.247 to 1.927)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC/3TC FDC, TDF/FTC FDC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The model includes the following covariates: treatment, baseline biomarker value, baseline CD4, and gender.
Method ANOVA
Comments Estimates are calculated from an ANOVA model. Parameters are analyzed based on log transformed data.
55.Other Pre-specified Outcome
Title Exploratory Analysis of Change From Baseline in Procollagen Type 1 Amino-terminal Propeptide (P1NP) at Week 96
Hide Description P1NP is a bone biomarker that was analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover.
Time Frame Baseline, Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Biomarker Population. Some participants had withdrawn by Week 96.
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 94 114
Geometric Mean (95% Confidence Interval)
Unit of Measure: micrograms per Liter (ug/L)
1.2
(1.1 to 1.2)
1.4
(1.3 to 1.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC/3TC FDC, TDF/FTC FDC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The model includes the following covariates: treatment, age, and baseline biomarker value.
Method ANOVA
Comments Estimates are calculated from ana ANOVA model. Parameters are analyzed based on log transformed data.
56.Other Pre-specified Outcome
Title Exploratory Analysis of Change From Baseline in Type 1 Collagen Cross-linked C-telopeptide at Week 96
Hide Description Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover.
Time Frame Baseline, Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Biomarker Population. Some participants had withdrawn by Week 96.
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 94 114
Geometric Mean (95% Confidence Interval)
Unit of Measure: nanograms per Liter (ng/L)
89.9
(25.1 to 154.7)
203.6
(143.3 to 264.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC/3TC FDC, TDF/FTC FDC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0019
Comments The model includes the following covariates: treatment, baseline biomarker value, and gender.
Method ANOVA
Comments Estimates are calculated from an ANOVA model.
57.Other Pre-specified Outcome
Title Exploratory Analysis of Change From Baseline in Osteocalcin at Week 96
Hide Description Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover.
Time Frame Baseline, Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Biomarker Population. Some participants had withdrawn by Week 96.
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 94 114
Geometric Mean (95% Confidence Interval)
Unit of Measure: ug/L
3.01
(0.87 to 5.14)
5.79
(3.68 to 7.90)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC/3TC FDC, TDF/FTC FDC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0019
Comments The model includes the following covariates: treatment, age, baseline biomarker value, and baseline CD4.
Method ANOVA
Comments Estimates are calculated from an ANOVA model.
58.Other Pre-specified Outcome
Title Exploratory Analysis of Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at Week 96
Hide Description Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover.
Time Frame Baseline, Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Biomarker Population. Some participants had withdrawn by Week 96.
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description:
Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Overall Number of Participants Analyzed 93 114
Geometric Mean (95% Confidence Interval)
Unit of Measure: ug/L
1.111
(-0.426 to 2.649)
2.542
(1.028 to 4.056)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABC/3TC FDC, TDF/FTC FDC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0266
Comments The model includes the following covariates: treatment, baseline biomarker value, and baseline CD4.
Method ANOVA
Comments Estimates are calculated from an ANOVA model.
Time Frame [Not Specified]
Adverse Event Reporting Description Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.
 
Arm/Group Title ABC/3TC FDC TDF/FTC FDC
Hide Arm/Group Description Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
All-Cause Mortality
ABC/3TC FDC TDF/FTC FDC
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ABC/3TC FDC TDF/FTC FDC
Affected / at Risk (%) Affected / at Risk (%)
Total   31/192 (16.15%)   20/193 (10.36%) 
Blood and lymphatic system disorders     
Neutropenia  1  1/192 (0.52%)  0/193 (0.00%) 
Cardiac disorders     
Acute myocardial infarction  1  0/192 (0.00%)  1/193 (0.52%) 
Congenital, familial and genetic disorders     
Porphyria non-acute  1  1/192 (0.52%)  0/193 (0.00%) 
Endocrine disorders     
Goitre  1  0/192 (0.00%)  1/193 (0.52%) 
Gastrointestinal disorders     
Abdominal hernia  1  1/192 (0.52%)  0/193 (0.00%) 
Diverticulum  1  1/192 (0.52%)  0/193 (0.00%) 
Gastritis  1  1/192 (0.52%)  0/193 (0.00%) 
Rectal haemorrhage  1  1/192 (0.52%)  0/193 (0.00%) 
General disorders     
Pyrexia  1  1/192 (0.52%)  0/193 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  1  1/192 (0.52%)  0/193 (0.00%) 
Cholelithiasis  1  1/192 (0.52%)  0/193 (0.00%) 
Cholestasis  1  0/192 (0.00%)  1/193 (0.52%) 
Cytolytic hepatitis  1  0/192 (0.00%)  1/193 (0.52%) 
Hepatitis  1  0/192 (0.00%)  1/193 (0.52%) 
Immune system disorders     
Drug hypersensitivity  1  5/192 (2.60%)  1/193 (0.52%) 
Hypersensitivity  1  3/192 (1.56%)  0/193 (0.00%) 
Immune reconstitution syndrome  1  2/192 (1.04%)  0/193 (0.00%) 
Infections and infestations     
Pneumonia  1  5/192 (2.60%)  1/193 (0.52%) 
Gastroenteritis  1  2/192 (1.04%)  0/193 (0.00%) 
Lower respiratory tract infection  1  1/192 (0.52%)  1/193 (0.52%) 
Pulmonary tuberculosis  1  1/192 (0.52%)  1/193 (0.52%) 
Abscess limb  1  0/192 (0.00%)  1/193 (0.52%) 
Endocarditis  1  0/192 (0.00%)  1/193 (0.52%) 
Erysipelas  1  1/192 (0.52%)  0/193 (0.00%) 
Eye infection toxoplasmal  1  1/192 (0.52%)  0/193 (0.00%) 
Herpes Zoster  1  1/192 (0.52%)  0/193 (0.00%) 
Scrotal abscess  1  1/192 (0.52%)  0/193 (0.00%) 
Staphylococcal abscess  1  0/192 (0.00%)  1/193 (0.52%) 
Tuberculosis  1  1/192 (0.52%)  0/193 (0.00%) 
Viral infection  1  1/192 (0.52%)  0/193 (0.00%) 
Injury, poisoning and procedural complications     
Accidental overdose  1  1/192 (0.52%)  0/193 (0.00%) 
Ankle fracture  1  0/192 (0.00%)  1/193 (0.52%) 
Forearm fracture  1  0/192 (0.00%)  1/193 (0.52%) 
Humerus fracture  1  0/192 (0.00%)  1/193 (0.52%) 
Meniscus lesion  1  1/192 (0.52%)  0/193 (0.00%) 
Investigations     
Cardiac murmur  1  1/192 (0.52%)  0/193 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  1/192 (0.52%)  0/193 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  0/192 (0.00%)  1/193 (0.52%) 
Osteoarthritis  1  0/192 (0.00%)  1/193 (0.52%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Burkitt's lymphoma  1  0/192 (0.00%)  1/193 (0.52%) 
Lymphoma  1  0/192 (0.00%)  1/193 (0.52%) 
Thymoma  1  1/192 (0.52%)  0/193 (0.00%) 
Nervous system disorders     
Convulsion  1  1/192 (0.52%)  0/193 (0.00%) 
Transient ischaemic attack  1  0/192 (0.00%)  1/193 (0.52%) 
Psychiatric disorders     
Acute stress disorder  1  0/192 (0.00%)  1/193 (0.52%) 
Apathy  1  0/192 (0.00%)  1/193 (0.52%) 
Renal and urinary disorders     
Renal failure  1  1/192 (0.52%)  0/193 (0.00%) 
Reproductive system and breast disorders     
Epididymitis  1  0/192 (0.00%)  1/193 (0.52%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/192 (0.52%)  0/193 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash maculo-papular  1  1/192 (0.52%)  0/193 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ABC/3TC FDC TDF/FTC FDC
Affected / at Risk (%) Affected / at Risk (%)
Total   172/192 (89.58%)   175/193 (90.67%) 
Gastrointestinal disorders     
Diarrhoea  1  36/192 (18.75%)  27/193 (13.99%) 
Nausea  1  17/192 (8.85%)  16/193 (8.29%) 
Vomiting  1  12/192 (6.25%)  11/193 (5.70%) 
General disorders     
Fatigue  1  14/192 (7.29%)  16/193 (8.29%) 
Infections and infestations     
Nasopharyngitis  1  39/192 (20.31%)  36/193 (18.65%) 
Influenza  1  12/192 (6.25%)  14/193 (7.25%) 
Investigations     
Bone density decreased  1  5/192 (2.60%)  15/193 (7.77%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  11/192 (5.73%)  16/193 (8.29%) 
Nervous system disorders     
Dizziness  1  48/192 (25.00%)  48/193 (24.87%) 
Headache  1  17/192 (8.85%)  29/193 (15.03%) 
Psychiatric disorders     
Abnormal dreams  1  23/192 (11.98%)  22/193 (11.40%) 
Insomnia  1  21/192 (10.94%)  18/193 (9.33%) 
Sleep disorder  1  14/192 (7.29%)  16/193 (8.29%) 
Depression  1  14/192 (7.29%)  15/193 (7.77%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  17/192 (8.85%)  13/193 (6.74%) 
Skin and subcutaneous tissue disorders     
Rash  1  18/192 (9.38%)  20/193 (10.36%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00549198     History of Changes
Other Study ID Numbers: CNA109586
First Submitted: October 24, 2007
First Posted: October 25, 2007
Results First Submitted: September 23, 2010
Results First Posted: October 15, 2010
Last Update Posted: April 12, 2011