Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Truvada	Truvada + nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI).
Zidovudine/Lamivudine	Zidovudine/lamivudine + nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI).

Participant Flow:   Overall Study

	Truvada	Zidovudine/Lamivudine
STARTED	39	41
COMPLETED	37	36
NOT COMPLETED	2	5
Adverse Event	1	4
Withdrawal by Subject	0	1
Noncompliance	1	0

Reporting Groups

	Description
Truvada	Truvada + NNRTI or PI.
Zidovudine/Lamivudine	Zidovudine/lamivudine + NNRTI or PI.

Baseline Measures

	Truvada	Zidovudine/Lamivudine	Total
Number of Participants   [units: participants]	39	41	80
Age   [units: years] Mean ± Standard Deviation	44 ± 10.6	44 ± 7.4	44 ± 9.0
Gender   [units: participants]
Female	11	4	15
Male	28	37	65
Race/Ethnicity, Customized   [units: Participants]
White	36	38	74
Black, of African heritage	1	2	3
Asian	1	0	1
Other	1	1	2
Region of Enrollment   [units: participants]
Spain	39	41	80
HIV-1 RNA Level   [units: Participants]
< 50 copies/mL	38	39	77
50 to < 400 copies/mL	1	2	3
Cluster determinant 4 (CD4) cell count   [units: cells/mm^3] Median ( Inter-Quartile Range )	655.0 ( 505.0 to 789.0 )	504.0 ( 363.0 to 756.0 )	600.5 ( 420.0 to 760.5 )
Total limb fat[1] [units: grams (g)] Median ( Full Range )	3565 ( 511 to 15932 )	3589 ( 903 to 28155 )	3589 ( 511 to 28155 )
Years on AZT/3TC   [units: Years] Median ( Inter-Quartile Range )	5.8 ( 4.2 to 7.2 )	6.2 ( 4.7 to 7.2 )	5.9 ( 4.6 to 7.2 )

1.  Primary:

Change From Baseline in Limb Fat at Week 48   [ Baseline to Week 48 ]

2.  Secondary:

Change From Baseline in the Mitochondrial DNA/Nuclear DNA Ratio (Oral Mucosa)   [ Baseline to Week 48 ]

3.  Secondary:

Change From Baseline in the Mitochondrial DNA/Nuclear DNA Ratio (Lymphocytes)   [ Baseline to Week 48 ]

4.  Secondary:

Change From Baseline in Lactate Concentration   [ Baseline to Week 48 ]

5.  Secondary:

Percentage of Days for Which Participants Were Compliant With Study Drug   [ Baseline to Week 72 ]

6.  Secondary:

Percentage of Participants Who Maintain Confirmed HIV-1 RNA < 50 Copies/mL   [ 48 weeks ]

7.  Secondary:

Percentage of Participants With HIV-1 RNA > 50 and < 400 Copies/mL   [ 48 weeks ]

8.  Secondary:

Percentage of Participants With Virologic Failure   [ 48 weeks ]

9.  Secondary:

Change From Baseline in Cluster Determinant 4 (CD4) Cell Count   [ Baseline to Week 48 ]

10.  Secondary:

Change From Baseline in Fasting Serum Triglycerides   [ Baseline to Week 48 ]

11.  Secondary:

Change From Baseline in Fasting Total Cholesterol   [ Baseline to Week 48 ]

12.  Secondary:

Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL)   [ Baseline to Week 48 ]

13.  Secondary:

Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL)   [ Baseline to Week 48 ]

14.  Secondary:

Change From Baseline in Hemoglobin   [ Baseline to Week 48 ]

15.  Secondary:

Change From Baseline in Hematocrit   [ Baseline to Week 48 ]

16.  Secondary:

Change From Baseline in Waist Circumference/Hip Circumference Ratio   [ Baseline to Week 48 ]

17.  Secondary:

Percentage of Participants With Any Adverse Event   [ 72 weeks ]

18.  Secondary:

Percentage of Participants Who Discontinue the Study Prematurely (Before Week 48) Due to Adverse Events.   [ 48 weeks ]