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

History of Changes

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

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
Number of Participants [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 )
Gender ^[1] [units: Participants]
Female	33	40	73
Male	159	153	312
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
Number of 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 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, treatmentvisit, baseline GFR by MDRDvisit 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
Number of 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 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, treatmentvisit, baseline GFR by MDRDvisit 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
Number of 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 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, treatmentvisit, baseline GFR by MDRDvisit 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
Number of 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 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, treatmentvisit, baseline GFR by CGvisit 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
Number of 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 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, treatmentvisit, baseline GFR by CGvisit 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
Number of 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 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, treatmentvisit, baseline GFR by CGvisit, baseline BMIvisit and baseline CD4visit.

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
Number of 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
Number of 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
Number of 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
Number of 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
Number of 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
Number of 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
Number of 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 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, treatmentvisit, baseline spine BMDvisit 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
Number of 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 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, treatmentvisit, baseline hip BMDvisit 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
Number of 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 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, treatmentvisit, baseline spine BMDvisit 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
Number of 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 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, treatmentvisit, baseline hip BMDvisit 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
Number of 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 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, treatmentvisit, baseline spine BMDvisit 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
Number of 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 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, treatmentvisit, baseline hip BMDvisit, 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
Number of 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
Number of 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
Number of 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
Number of 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
Number of 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
Number of 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
Number of 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
Number of 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
Number of 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
Number of 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
Number of 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

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
Number of 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

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
Number of 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
Number of 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

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
Number of 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

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
Number of 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:

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
Number of 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

36. Secondary:

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
Number of 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

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
Number of 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
Number of 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
Number of 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
Number of 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
Number of 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
Number of 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
Number of 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
Number of 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
Number of 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
Number of 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
Number of 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
Number of 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
Number of 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
Number of 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
Number of 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 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
Number of 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 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
Number of 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 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
Number of 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 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
Number of 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 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
Number of 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 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
Number of 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 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
Number of 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 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

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

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.

Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

Publications:

Post FA, Moyle GJ, Stellbrink HJ, et al. Randomized comparison of renal effects, efficacy, and safety with once-daily abacavir/lamivudine versus tenofovir/emtricitabine, administered with efavirenz, in antiretroviral-naive, HIV-1-infected adults: 48-week results from the ASSERT study. [JAIDS]. 2010;55(1):49-57.

Molina JM, Andrade-Villanueva J, Echevarria J, Chetchotisakd P, Corral J, David N, Moyle G, Mancini M, Percival L, Yang R, Wirtz V, Lataillade M, Absalon J, McGrath D; CASTLE Study Team. Once-daily atazanavir/ritonavir compared with twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naive HIV-1-infected patients: 96-week efficacy and safety results of the CASTLE study. J Acquir Immune Defic Syndr. 2010 Mar 1;53(3):323-32.

Publications automatically indexed to this study:

Post FA, Moyle GJ, Stellbrink HJ, Domingo P, Podzamczer D, Fisher M, Norden AG, Cavassini M, Rieger A, Khuong-Josses MA, Branco T, Pearce HC, Givens N, Vavro C, Lim ML. Randomized comparison of renal effects, efficacy, and safety with once-daily abacavir/lamivudine versus tenofovir/emtricitabine, administered with efavirenz, in antiretroviral-naive, HIV-1-infected adults: 48-week results from the ASSERT study. J Acquir Immune Defic Syndr. 2010 Sep 1;55(1):49-57.

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

To Top