Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00549198
First received: October 24, 2007
Last updated: April 7, 2011
Last verified: April 2011
Results First Received: September 23, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Infection, Human Immunodeficiency Virus I
HIV Infection
Interventions: Drug: Abacavir/lamivudine and efavirenz
Drug: Tenofovir/Emtricitabine and efavirenz

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Participant Flow:   Overall Study
    ABC/3TC FDC   TDF/FTC FDC
STARTED   195 [1]   197 [2] 
COMPLETED   115   134 
NOT COMPLETED   80   63 
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).



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Total Total of all reporting groups

Baseline Measures
   ABC/3TC FDC   TDF/FTC FDC   Total 
Overall Participants Analyzed 
[Units: Participants]
 192   193   385 
Age [1] 
[Units: Years]
Median (Full Range)
 38.0 
 (19 to 70) 
 36.0 
 (18 to 66) 
 37.0 
 (18 to 70) 
[1] 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.
Gender [1] 
[Units: Participants]
     
Female   33   40   73 
Male   159   153   312 
[1] 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] 
[Units: 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] 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.


  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 48   [ Time Frame: Baseline, Week 48 ]

Measure Type Primary
Measure Title Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 48
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-Treat-Exposed (ITT-E) Population: all randomized participants who received at least one dose of study medication

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 192   193 
Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 48 
[Units: Milliliters per minute (mL/min)/1.73 m^2]
Mean (Standard Error)
 0.22  (0.890)   1.18  (0.828) 


Statistical Analysis 1 for Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 48
Groups [1] All groups
Method [2] Mixed Models Analysis
P Value [3] 0.435
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The correlation matrix for within-subject errors is unstructured.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  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.



2.  Secondary:   Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 24   [ Time Frame: Baseline, Week 24 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 24
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 192   193 
Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 24 
[Units: mL/min/1.73m^2]
Mean (Standard Error)
 2.78  (0.884)   0.43  (0.842) 


Statistical Analysis 1 for Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 24
Groups [1] All groups
Method [2] Mixed Models Analysis
P Value [3] 0.057
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The correlation matrix for within-subject errors is unstructured.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  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.



3.  Secondary:   Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 96   [ Time Frame: Baseline, Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 96
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 192   193 
Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 96 
[Units: mL/min/1.73m^2]
Mean (Standard Error)
 1.48  (1.022)   -1.15  (0.944) 


Statistical Analysis 1 for Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 96
Groups [1] All groups
Method [2] Mixed Models Analysis
P Value [3] 0.060
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The correlation matrix for within-subject errors is unstructured.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  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.



4.  Secondary:   Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 24   [ Time Frame: Baseline, Week 24 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 24
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 192   193 
Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 24 
[Units: mL/min]
Mean (Standard Error)
 4.27  (0.944)   2.54  (0.897) 


Statistical Analysis 1 for Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 24
Groups [1] All groups
Method [2] Mixed Models Analysis
P Value [3] 0.186
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The correlation matrix for within-subject errors is unstructured.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  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.



5.  Secondary:   Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 48   [ Time Frame: Baseline, Week 48 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 48
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 192   193 
Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 48 
[Units: mL/min]
Mean (Standard Error)
 2.66  (1.005)   3.80  (0.933) 


Statistical Analysis 1 for Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 48
Groups [1] All groups
Method [2] Mixed Models Analysis
P Value [3] 0.413
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The correlation matrix for within-subject errors is unstructured.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  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.



6.  Secondary:   Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 96   [ Time Frame: Baseline, Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 96
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 192   193 
Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 96 
[Units: mL/min]
Mean (Standard Error)
 4.37  (1.228)   2.68  (1.133) 


Statistical Analysis 1 for Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 96
Groups [1] All groups
Method [2] Mixed Models Analysis
P Value [3] 0.315
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The correlation matrix for within-subject errors is unstructured.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  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.



7.  Secondary:   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   [ Time Frame: Baseline, Week 24 ]

Measure Type Secondary
Measure 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
Measure Description mL, milliliter; min, minute; m^2, meters squared
Time Frame Baseline, Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population. Some participants had withdrawn from the study by Week 24.

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 156   173 
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 
[Units: 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 

No statistical analysis provided for 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



8.  Secondary:   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   [ Time Frame: Baseline, Week 48 ]

Measure Type Secondary
Measure 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
Measure Description mL, milliliter; min, minute; m^2, meters squared
Time Frame Baseline, Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population. Some participants had withdrawn by Week 48.

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 136   159 
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 
[Units: 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 

No statistical analysis provided for 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



9.  Secondary:   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   [ Time Frame: Baseline, Week 96 ]

Measure Type Secondary
Measure 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
Measure Description mL, milliliter; min, minute; m^2, meters squared
Time Frame Baseline, Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population. Some participants had withdrawn by Week 96.

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 111   131 
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 
[Units: 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 

No statistical analysis provided for 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



10.  Secondary:   Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24   [ Time Frame: Baseline, Week 24 ]

Measure Type Secondary
Measure 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
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population. Some participants had withdrawn by Week 24.

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 114   135 
Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24 
[Units: Participants]
   
Normal   97   114 
Stage 1   11   15 
Stage 2   5   5 
Stage 3   1   1 
Stage 4   0   0 
Stage 5   0   0 

No statistical analysis provided for Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24



11.  Secondary:   Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48   [ Time Frame: Baseline, Week 48 ]

Measure Type Secondary
Measure 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
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population. Some participants had withdrawn by Week 48.

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 112   133 
Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48 
[Units: 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 

No statistical analysis provided for Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48



12.  Secondary:   Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96   [ Time Frame: Baseline, Week 96 ]

Measure Type Secondary
Measure 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
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population. Some participants had withdrawn by Week 96.

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 93   109 
Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96 
[Units: 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 

No statistical analysis provided for Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96



13.  Secondary:   Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24   [ Time Frame: Baseline, Week 24 ]

Measure Type Secondary
Measure Title Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 192   193 
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24 
[Units: Percent change]
Mean (Standard Error)
 -2.12  (0.0011)   -3.30  (0.0011) 


Statistical Analysis 1 for Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24
Groups [1] All groups
Method [2] Mixed Models Analysis
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The correlation matrix for within-subject errors is unstructured.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  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.



14.  Secondary:   Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24   [ Time Frame: Baseline, Week 24 ]

Measure Type Secondary
Measure Title Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 192   193 
Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24 
[Units: Percent change]
Mean (Standard Error)
 -1.19  (0.0007)   -2.73  (0.0007) 


Statistical Analysis 1 for Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24
Groups [1] All groups
Method [2] Mixed Models Analysis
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The correlation matrix for within-subject errors is unstructured.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  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.



15.  Secondary:   Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48   [ Time Frame: Baseline, Week 48 ]

Measure Type Secondary
Measure Title Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 192   193 
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48 
[Units: Percent change]
Mean (Standard Error)
 -1.59  (0.0013)   -2.41  (0.0012) 


Statistical Analysis 1 for Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48
Groups [1] All groups
Method [2] Mixed Models Analysis
P Value [3] 0.036
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The correlation matrix for within-subject errors is unstructured.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  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.



16.  Secondary:   Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48   [ Time Frame: Baseline, Week 48 ]

Measure Type Secondary
Measure Title Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 192   193 
Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48 
[Units: Percent change]
Mean (Standard Error)
 -1.90  (0.0010)   -3.56  (0.0009) 


Statistical Analysis 1 for Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48
Groups [1] All groups
Method [2] Mixed Models Analysis
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Correlation matrix for within-subject errors is unstructured.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  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.



17.  Secondary:   Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96   [ Time Frame: Baseline, Week 96 ]

Measure Type Secondary
Measure Title Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 192   193 
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96 
[Units: Percent change]
Mean (Standard Error)
 -0.87  (0.0017)   -1.70  (0.0015) 


Statistical Analysis 1 for Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96
Groups [1] All groups
Method [2] Mixed Models Analysis
P Value [3] 0.112
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  correlation matrix for within-subject errors is unstructured.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  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.



18.  Secondary:   Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96   [ Time Frame: Baseline, Week 96 ]

Measure Type Secondary
Measure Title Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 192   193 
Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96 
[Units: Percent change]
Mean (Standard Error)
 -2.17  (0.0013)   -3.55  (0.0012) 


Statistical Analysis 1 for Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96
Groups [1] All groups
Method [2] Mixed Models Analysis
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The correlation matrix for within-subject errors is unstructured.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  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.



19.  Secondary:   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   [ Time Frame: Baseline, Week 24 ]

Measure Type Secondary
Measure 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
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population. Some participants had withdrawn by Week 24/did not have a DXA scan performed. DXA, dual energy x-ray absorptiometry.

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 142   165 
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 
[Units: 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 

No statistical analysis provided for 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



20.  Secondary:   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   [ Time Frame: Baseline, Week 48 ]

Measure Type Secondary
Measure 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
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population. Some participants had withdrawn by Week 48/did not have a DXA scan performed. DXA, dual energy x-ray absorptiometry.

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 125   141 
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 
[Units: 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 

No statistical analysis provided for 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



21.  Secondary:   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   [ Time Frame: Baseline, Week 96 ]

Measure Type Secondary
Measure 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
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population. Some participants had withdrawn by Week 96/did not have a DXA scan performed. DXA, dual energy x-ray absorptiometry.

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 59   79 
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 
[Units: 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 

No statistical analysis provided for 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



22.  Secondary:   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   [ Time Frame: Week 24 ]

Measure Type Secondary
Measure 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
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population. Some participants had withdrawn by Week 24.

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 149   173 
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 
[Units: 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 

No statistical analysis provided for 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



23.  Secondary:   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   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure 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
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population. Some participants had withdrawn by Week 48.

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 132   147 
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 
[Units: 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 

No statistical analysis provided for 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



24.  Secondary:   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   [ Time Frame: Week 96 ]

Measure Type Secondary
Measure 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
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population. Some participants had withdrawn by Week 96.

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 65   82 
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 
[Units: 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 

No statistical analysis provided for 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



25.  Secondary:   Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24   [ Time Frame: Baseline to Week 24 ]

Measure Type Secondary
Measure Title Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population: all randomized participants who received at least one dose of study medication

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 192   193 
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24 
[Units: Participants]
   
Any event   26   14 
Drug hypersensitivity   11   1 
Rash   2   3 
Dizziness   0   2 
Hypersensitivity   3   0 
Drug eruption   1   1 

No statistical analysis provided for Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24



26.  Secondary:   Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48   [ Time Frame: Baseline to Week 48 ]

Measure Type Secondary
Measure Title Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population: all randomized participants who received at least one dose of study medication

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 192   193 
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48 
[Units: 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 

No statistical analysis provided for Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48



27.  Secondary:   Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population: all randomized participants who received at least one dose of study medication

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 192   193 
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96 
[Units: 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 

No statistical analysis provided for Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96



28.  Secondary:   Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24   [ Time Frame: Baseline, Week 24 ]

Measure Type Secondary
Measure Title Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 192   193 
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24 
[Units: 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 

No statistical analysis provided for Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24



29.  Secondary:   Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48   [ Time Frame: Baseline, Week 48 ]

Measure Type Secondary
Measure Title Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 192   193 
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48 
[Units: 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 

No statistical analysis provided for Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48



30.  Secondary:   Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96   [ Time Frame: Baseline, Week 96 ]

Measure Type Secondary
Measure Title Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 192   193 
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96 
[Units: 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 

No statistical analysis provided for Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96



31.  Secondary:   Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24   [ Time Frame: Baseline, Week 24 ]

Measure Type Secondary
Measure 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
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 192   193 
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 
[Units: 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 

No statistical analysis provided for Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24



32.  Secondary:   Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48   [ Time Frame: Baseline, Week 48 ]

Measure Type Secondary
Measure 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
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 192   193 
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 
[Units: 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 

No statistical analysis provided for Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48



33.  Secondary:   Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96   [ Time Frame: Baseline, Week 96 ]

Measure Type Secondary
Measure 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
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 192   193 
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 
[Units: 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 

No statistical analysis provided for Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96



34.  Secondary:   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   [ Time Frame: Baseline, Week 24 ]

Measure Type Secondary
Measure 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
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 192   193 
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 
[Units: 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 

No statistical analysis provided for 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



35.  Secondary:   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   [ Time Frame: Baseline, Week 48 ]

Measure Type Secondary
Measure 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
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 192   193 
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 
[Units: 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 

No statistical analysis provided for 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



36.  Secondary:   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   [ Time Frame: Baseline, Week 96 ]

Measure Type Secondary
Measure 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
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 192   193 
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 
[Units: 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 

No statistical analysis provided for 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



37.  Secondary:   Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24   [ Time Frame: Baseline, Week 24 ]

Measure Type Secondary
Measure Title Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 192   193 
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 
[Units: 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 

No statistical analysis provided for Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24



38.  Secondary:   Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48   [ Time Frame: Baseline, Week 48 ]

Measure Type Secondary
Measure Title Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 192   193 
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 
[Units: 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 

No statistical analysis provided for Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48



39.  Secondary:   Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96   [ Time Frame: Baseline, Week 96 ]

Measure Type Secondary
Measure Title Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 192   193 
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 
[Units: 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 

No statistical analysis provided for Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96



40.  Secondary:   Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24   [ Time Frame: Week 24 ]

Measure Type Secondary
Measure Title Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 192   193 
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 
[Units: 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 

No statistical analysis provided for Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24



41.  Secondary:   Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 192   193 
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 
[Units: 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 

No statistical analysis provided for Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48



42.  Secondary:   Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96   [ Time Frame: Week 96 ]

Measure Type Secondary
Measure Title Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 192   193 
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 
[Units: 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 

No statistical analysis provided for Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96



43.  Secondary:   Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 24   [ Time Frame: Week 24 ]

Measure Type Secondary
Measure Title Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 24
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 192   193 
Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 24 
[Units: Participants]
   
<50 copies/mL   126   144 
<400 copies/mL   147   168 

No statistical analysis provided for Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 24



44.  Secondary:   Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 48   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 48
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 192   193 
Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 48 
[Units: Participants]
   
<50 copies/mL   121   145 
<400 copies/mL   130   151 

No statistical analysis provided for Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 48



45.  Secondary:   Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 96   [ Time Frame: Week 96 ]

Measure Type Secondary
Measure Title Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 96
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 192   193 
Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 96 
[Units: Participants]
   
<50 copies/mL   98   113 
<400 copies/mL   110   126 

No statistical analysis provided for Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 96



46.  Secondary:   Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 24   [ Time Frame: Baseline, Week 24 ]

Measure Type Secondary
Measure Title Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 24
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population. Some participants had withdrawn by Week 24.

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 153   172 
Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 24 
[Units: Cells/millimeters cubed (mm^3)]
Median (Inter-Quartile Range)
 110.0 
 (50.0 to 180.0) 
 100.0 
 (45.0 to 150.0) 

No statistical analysis provided for Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 24



47.  Secondary:   Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 48   [ Time Frame: Baseline, Week 48 ]

Measure Type Secondary
Measure Title Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 48
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population. Some participants had withdrawn by Week 48.

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 136   156 
Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 48 
[Units: Cells/mm^3]
Median (Inter-Quartile Range)
 150.0 
 (95.0 to 270.0) 
 150.0 
 (80.0 to 215.0) 

No statistical analysis provided for Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 48



48.  Secondary:   Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 96   [ Time Frame: Baseline, Week 96 ]

Measure Type Secondary
Measure Title Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 96
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT-E Population. Some participants had withdrawn by Week 96.

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 110   128 
Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 96 
[Units: Cells/mm^3]
Median (Inter-Quartile Range)
 235.0 
 (130.0 to 390.0) 
 220.0 
 (150.0 to 315.0) 

No statistical analysis provided for Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 96



49.  Secondary:   Number of Participants Classified as Protocol-defined Failures With Treatment-emergent Resistance to Study Drug in the Indicated Viruses at Week 96   [ Time Frame: Week 96 ]

Measure Type Secondary
Measure Title Number of Participants Classified as Protocol-defined Failures With Treatment-emergent Resistance to Study Drug in the Indicated Viruses at Week 96
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 7   3 
Number of Participants Classified as Protocol-defined Failures With Treatment-emergent Resistance to Study Drug in the Indicated Viruses at Week 96 
[Units: Participants]
   
Any treatment-emergent mutation   4   0 
NRTI   4   0 
NNRTI   2   0 

No statistical analysis provided for Number of Participants Classified as Protocol-defined Failures With Treatment-emergent Resistance to Study Drug in the Indicated Viruses at Week 96



50.  Secondary:   Number of Participants Who Indicated "Yes" or "No" to the Question of Whether Unplanned Healthcare Resources Were Utilized   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Number of Participants Who Indicated "Yes" or "No" to the Question of Whether Unplanned Healthcare Resources Were Utilized
Measure Description Participants were asked at each visit whether or not they utilized unplanned healthcare resources.
Time Frame Baseline to Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 178   183 
Number of Participants Who Indicated "Yes" or "No" to the Question of Whether Unplanned Healthcare Resources Were Utilized 
[Units: 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 

No statistical analysis provided for Number of Participants Who Indicated "Yes" or "No" to the Question of Whether Unplanned Healthcare Resources Were Utilized



51.  Other Pre-specified:   Exploratory Analysis of Change From Baseline in Albumin as a Ratio to Urine Creatinine at Week 96   [ Time Frame: Baseline, Week 96 ]

Measure Type Other Pre-specified
Measure Title Exploratory Analysis of Change From Baseline in Albumin as a Ratio to Urine Creatinine at Week 96
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 103   120 
Exploratory Analysis of Change From Baseline in Albumin as a Ratio to Urine Creatinine at Week 96 
[Units: Ratio]
Geometric Mean (95% Confidence Interval)
 0.872 
 (0.716 to 1.062) 
 0.973 
 (0.806 to 1.174) 


Statistical Analysis 1 for Exploratory Analysis of Change From Baseline in Albumin as a Ratio to Urine Creatinine at Week 96
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.3025
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Estimates are calculated from an ANOVA model. Parameters are analyzed based on log transformed data.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  The model includes the following covariates: treatment, age, baseline biomarker value, and gender.



52.  Other Pre-specified:   Exploratory Analysis of Change From Baseline in Beta 2 Microglobulin (B2M) as a Ratio to Urine Creatinine at Week 96   [ Time Frame: Baseline, Week 96 ]

Measure Type Other Pre-specified
Measure Title Exploratory Analysis of Change From Baseline in Beta 2 Microglobulin (B2M) as a Ratio to Urine Creatinine at Week 96
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population. Some participants had withdrawn by Week 96.

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 87   105 
Exploratory Analysis of Change From Baseline in Beta 2 Microglobulin (B2M) as a Ratio to Urine Creatinine at Week 96 
[Units: Ratio]
Geometric Mean (95% Confidence Interval)
 0.542 
 (0.370 to 0.792) 
 0.984 
 (0.684 to 1.416) 


Statistical Analysis 1 for Exploratory Analysis of Change From Baseline in Beta 2 Microglobulin (B2M) as a Ratio to Urine Creatinine at Week 96
Groups [1] All groups
Method [2] ANOVA
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Estimates are calculated from an ANOVA model. Parameters are analyzed based on log transformed data.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  The model includes the following covariates: treatment, age, baseline biomarker value, baseline CD4, and gender.



53.  Other Pre-specified:   Exploratory Analysis of Change From Baseline in N-acetyl-B-glucosaminidase (NAG) as a Ratio to Urine Creatinine at Week 96   [ Time Frame: Baseline, Week 96 ]

Measure Type Other Pre-specified
Measure Title Exploratory Analysis of Change From Baseline in N-acetyl-B-glucosaminidase (NAG) as a Ratio to Urine Creatinine at Week 96
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 103   120 
Exploratory Analysis of Change From Baseline in N-acetyl-B-glucosaminidase (NAG) as a Ratio to Urine Creatinine at Week 96 
[Units: Ratio]
Geometric Mean (95% Confidence Interval)
 0.868 
 (0.774 to 0.974) 
 0.939 
 (0.844 to 1.044) 


Statistical Analysis 1 for Exploratory Analysis of Change From Baseline in N-acetyl-B-glucosaminidase (NAG) as a Ratio to Urine Creatinine at Week 96
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.3323
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Estimates are calculated from an ANOVA model. Parameters are analyzed based on log transformed data.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  The model includes the following covariates: treatment, age, and baseline biomarker value.



54.  Other Pre-specified:   Exploratory Analysis of Change From Baseline in Retinol Binding Protein (RBP) as a Ratio to Urine Creatinine at Week 96   [ Time Frame: Baseline, Week 96 ]

Measure Type Other Pre-specified
Measure Title Exploratory Analysis of Change From Baseline in Retinol Binding Protein (RBP) as a Ratio to Urine Creatinine at Week 96
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 103   120 
Exploratory Analysis of Change From Baseline in Retinol Binding Protein (RBP) as a Ratio to Urine Creatinine at Week 96 
[Units: Ratio]
Geometric Mean (95% Confidence Interval)
 1.099 
 (0.882 to 1.369) 
 1.550 
 (1.247 to 1.927) 


Statistical Analysis 1 for Exploratory Analysis of Change From Baseline in Retinol Binding Protein (RBP) as a Ratio to Urine Creatinine at Week 96
Groups [1] All groups
Method [2] ANOVA
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Estimates are calculated from an ANOVA model. Parameters are analyzed based on log transformed data.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  The model includes the following covariates: treatment, baseline biomarker value, baseline CD4, and gender.



55.  Other Pre-specified:   Exploratory Analysis of Change From Baseline in Procollagen Type 1 Amino-terminal Propeptide (P1NP) at Week 96   [ Time Frame: Baseline, Week 96 ]

Measure Type Other Pre-specified
Measure Title Exploratory Analysis of Change From Baseline in Procollagen Type 1 Amino-terminal Propeptide (P1NP) at Week 96
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Biomarker Population. Some participants had withdrawn by Week 96.

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 94   114 
Exploratory Analysis of Change From Baseline in Procollagen Type 1 Amino-terminal Propeptide (P1NP) at Week 96 
[Units: Micrograms per Liter (ug/L)]
Geometric Mean (95% Confidence Interval)
 1.2 
 (1.1 to 1.2) 
 1.4 
 (1.3 to 1.5) 


Statistical Analysis 1 for Exploratory Analysis of Change From Baseline in Procollagen Type 1 Amino-terminal Propeptide (P1NP) at Week 96
Groups [1] All groups
Method [2] ANOVA
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Estimates are calculated from ana ANOVA model. Parameters are analyzed based on log transformed data.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  The model includes the following covariates: treatment, age, and baseline biomarker value.



56.  Other Pre-specified:   Exploratory Analysis of Change From Baseline in Type 1 Collagen Cross-linked C-telopeptide at Week 96   [ Time Frame: Baseline, Week 96 ]

Measure Type Other Pre-specified
Measure Title Exploratory Analysis of Change From Baseline in Type 1 Collagen Cross-linked C-telopeptide at Week 96
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Biomarker Population. Some participants had withdrawn by Week 96.

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 94   114 
Exploratory Analysis of Change From Baseline in Type 1 Collagen Cross-linked C-telopeptide at Week 96 
[Units: Nanograms per Liter (ng/L)]
Geometric Mean (95% Confidence Interval)
 89.9 
 (25.1 to 154.7) 
 203.6 
 (143.3 to 264.0) 


Statistical Analysis 1 for Exploratory Analysis of Change From Baseline in Type 1 Collagen Cross-linked C-telopeptide at Week 96
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.0019
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Estimates are calculated from an ANOVA model.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  The model includes the following covariates: treatment, baseline biomarker value, and gender.



57.  Other Pre-specified:   Exploratory Analysis of Change From Baseline in Osteocalcin at Week 96   [ Time Frame: Baseline, Week 96 ]

Measure Type Other Pre-specified
Measure Title Exploratory Analysis of Change From Baseline in Osteocalcin at Week 96
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Biomarker Population. Some participants had withdrawn by Week 96.

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 94   114 
Exploratory Analysis of Change From Baseline in Osteocalcin at Week 96 
[Units: ug/L]
Geometric Mean (95% Confidence Interval)
 3.01 
 (0.87 to 5.14) 
 5.79 
 (3.68 to 7.90) 


Statistical Analysis 1 for Exploratory Analysis of Change From Baseline in Osteocalcin at Week 96
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.0019
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Estimates are calculated from an ANOVA model.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  The model includes the following covariates: treatment, age, baseline biomarker value, and baseline CD4.



58.  Other Pre-specified:   Exploratory Analysis of Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at Week 96   [ Time Frame: Baseline, Week 96 ]

Measure Type Other Pre-specified
Measure Title Exploratory Analysis of Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at Week 96
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Biomarker Population. Some participants had withdrawn by Week 96.

Reporting Groups
  Description
ABC/3TC FDC Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Measured Values
   ABC/3TC FDC   TDF/FTC FDC 
Participants Analyzed 
[Units: Participants]
 93   114 
Exploratory Analysis of Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at Week 96 
[Units: ug/L]
Geometric Mean (95% Confidence Interval)
 1.111 
 (-0.426 to 2.649) 
 2.542 
 (1.028 to 4.056) 


Statistical Analysis 1 for Exploratory Analysis of Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at Week 96
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.0266
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Estimates are calculated from an ANOVA model.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  The model includes the following covariates: treatment, baseline biomarker value, and baseline CD4.




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications:

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00549198     History of Changes
Other Study ID Numbers: CNA109586
Study First Received: October 24, 2007
Results First Received: September 23, 2010
Last Updated: April 7, 2011
Health Authority: Austria: Agency for Health and Food Safety
Germany: Federal Institute for Drugs and Medical Devices
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment