Peripheral Body Fat Distribution After Switching Zidovudine and Lamivudine to Truvada - Study Results

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment
Condition:	HIV-1
Interventions:	Drug: Truvada Drug: Zidovudine/lamivudine

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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	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).

	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

	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]	Measured using DEXA. Total limb fat is the sum of the left arm, right arm, left leg, and right leg.

Outcome Measures

1. Primary:

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

Measure Type	Primary
Measure Title	Change From Baseline in Limb Fat at Week 48
Measure Description	Limb fat was measured by DEXA. Change = Week 48 value minus baseline value.
Time Frame	Baseline to Week 48
Safety Issue	Yes

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.
Treated participants. Number of participants analyzed is those with baseline and post-baseline DEXA data. Last post-baseline observation carried forward (LOCF) method was used if the Week 48 limb fat value was missing.

Reporting Groups

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

Measured Values

	Truvada	Zidovudine/Lamivudine
Number of Participants Analyzed [units: participants]	38	38
Change From Baseline in Limb Fat at Week 48 [units: g] Median ( Inter-Quartile Range )	392 ( -102 to 1056 )	-257 ( -751 to 148 )

Statistical Analysis 1 for Change From Baseline in Limb Fat at Week 48

Groups ^[1]	All groups
Method ^[2]	Wilcoxon Rank Sum test
P Value ^[3]	0.0014

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No adjustments were made.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No adjustments for multiple comparisons were made.

2. Secondary:

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

Measure Type	Secondary
Measure Title	Change From Baseline in the Mitochondrial DNA/Nuclear DNA Ratio (Oral Mucosa)
Measure Description	Change = Week 48 value minus baseline value.
Time Frame	Baseline to Week 48
Safety Issue	Yes

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.
Treated participants. Missing values were excluded.

Reporting Groups

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

Measured Values

	Truvada	Zidovudine/Lamivudine
Number of Participants Analyzed [units: participants]	34	35
Change From Baseline in the Mitochondrial DNA/Nuclear DNA Ratio (Oral Mucosa) [units: Ratio] Median ( Inter-Quartile Range )	62.0 ( 20.0 to 212.0 )	97.0 ( 20.0 to 197.0 )

Statistical Analysis 1 for Change From Baseline in the Mitochondrial DNA/Nuclear DNA Ratio (Oral Mucosa)

Groups ^[1]	All groups
Method ^[2]	Wilcoxon Rank Sum test
P Value ^[3]	0.9713

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No adjustments were made.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No adjustments for multiple comparisons were made.

3. Secondary:

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

Measure Type	Secondary
Measure Title	Change From Baseline in the Mitochondrial DNA/Nuclear DNA Ratio (Lymphocytes)
Measure Description	Change = Week 48 value minus baseline value.
Time Frame	Baseline to Week 48
Safety Issue	Yes

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.
Treated participants. Missing values were excluded.

Reporting Groups

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

Measured Values

	Truvada	Zidovudine/Lamivudine
Number of Participants Analyzed [units: participants]	36	35
Change From Baseline in the Mitochondrial DNA/Nuclear DNA Ratio (Lymphocytes) [units: Ratio] Median ( Inter-Quartile Range )	36.0 ( 2.0 to 89.5 )	43.0 ( 1.0 to 72.0 )

Statistical Analysis 1 for Change From Baseline in the Mitochondrial DNA/Nuclear DNA Ratio (Lymphocytes)

Groups ^[1]	All groups
Method ^[2]	Wilcoxon Rank Sum test
P Value ^[3]	0.9725

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No adjustments were made.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No adjustments for multiple comparisons were made.

4. Secondary:

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

Measure Type	Secondary
Measure Title	Change From Baseline in Lactate Concentration
Measure Description	Change = Week 48 value minus baseline value.
Time Frame	Baseline to Week 48
Safety Issue	Yes

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.
Treated participants. Missing values were excluded.

Reporting Groups

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

Measured Values

	Truvada	Zidovudine/Lamivudine
Number of Participants Analyzed [units: participants]	27	30
Change From Baseline in Lactate Concentration [units: mmol/L] Median ( Inter-Quartile Range )	-0.23 ( -0.55 to 0.00 )	0.09 ( -0.12 to 0.43 )

Statistical Analysis 1 for Change From Baseline in Lactate Concentration

Groups ^[1]	All groups
Method ^[2]	Wilcoxon Rank Sum test
P Value ^[3]	0.0078

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No adjustments were made.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No adjustments for multiple comparisons were made.

5. Secondary:

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

Measure Type	Secondary
Measure Title	Percentage of Days for Which Participants Were Compliant With Study Drug
Measure Description	Compliance = [1 - [(sum of days with a missed dose [per Question 6 study medication assessment questionnaire [SMAQ])/(sum of days between SMAQ visits)]] *100 for visits with SMAQ data. An assessable visit is one where the number of missed days was reported [Question 6] and the number of days between SMAQ visits could be calculated.
Time Frame	Baseline to Week 72
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.
Treated participants.

Reporting Groups

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

Measured Values

	Truvada	Zidovudine/Lamivudine
Number of Participants Analyzed [units: participants]	39	41
Percentage of Days for Which Participants Were Compliant With Study Drug [units: Percentage of days with compliance] Median ( Inter-Quartile Range )	100.0 ( 99.8 to 100.0 )	100.0 ( 99.6 to 100.0 )

Statistical Analysis 1 for Percentage of Days for Which Participants Were Compliant With Study Drug

Groups ^[1]	All groups
Method ^[2]	Wilcoxon Rank Sum test
P Value ^[3]	0.6984

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null Hypothesis: percentages of days with compliance in the two treatment groups are equal. Alternative Hypothesis: percentages of days with compliance in the two treatment groups are different (two sided).
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No adjustments were made.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No adjustments for multiple comparisons were made.

6. Secondary:

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

Measure Type	Secondary
Measure Title	Percentage of Participants Who Maintain Confirmed HIV-1 RNA < 50 Copies/mL
Measure Description	No text entered.
Time Frame	48 weeks
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.
Treated participants. Missing values were treated as failure (i.e., as HIV-1 RNA greater than or equal to 50 copies/mL).

Reporting Groups

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

Measured Values

	Truvada	Zidovudine/Lamivudine
Number of Participants Analyzed [units: participants]	39	41
Percentage of Participants Who Maintain Confirmed HIV-1 RNA < 50 Copies/mL [units: Percentage of participants]	92.3	78.0

Statistical Analysis 1 for Percentage of Participants Who Maintain Confirmed HIV-1 RNA < 50 Copies/mL

Groups ^[1]	All groups
Method ^[2]	Fisher Exact
P Value ^[3]	0.1165
Mean Difference (Net) ^[4]	14.3
95% Confidence Interval	( -0.9 to 29.4 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null Hypothesis: treatment is not associated with the observed virologic response. Alternative Hypothesis: treatment is associated with the observed virologic response.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No adjustments were made.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No adjustments for multiple comparisons were made.
[4]	Other relevant estimation information:
	The difference is for Truvada minus zidovudine/lamivudine. The 95% confidence interval on the mean difference between treatment groups is based on the normal approximation.

7. Secondary:

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

Measure Type	Secondary
Measure Title	Percentage of Participants With HIV-1 RNA > 50 and < 400 Copies/mL
Measure Description	No text entered.
Time Frame	48 weeks
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.
Treated participants.

Reporting Groups

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

Measured Values

	Truvada	Zidovudine/Lamivudine
Number of Participants Analyzed [units: participants]	39	41
Percentage of Participants With HIV-1 RNA > 50 and < 400 Copies/mL [units: Percentage of participants]	0	5

No statistical analysis provided for Percentage of Participants With HIV-1 RNA > 50 and < 400 Copies/mL

8. Secondary:

Percentage of Participants With Virologic Failure [ 48 weeks ]

Measure Type	Secondary
Measure Title	Percentage of Participants With Virologic Failure
Measure Description	Virologic failure was defined as two consecutive HIV RNA values > 400 copies/mL.
Time Frame	48 weeks
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.
Treated participants.

Reporting Groups

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

Measured Values

	Truvada	Zidovudine/Lamivudine
Number of Participants Analyzed [units: participants]	39	41
Percentage of Participants With Virologic Failure [units: Percentage of participants]	0	0

No statistical analysis provided for Percentage of Participants With Virologic Failure

9. Secondary:

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

Measure Type	Secondary
Measure Title	Change From Baseline in Cluster Determinant 4 (CD4) Cell Count
Measure Description	Change = Week 48 value minus baseline value.
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.
Treated participants. Missing values were excluded.

Reporting Groups

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

Measured Values

	Truvada	Zidovudine/Lamivudine
Number of Participants Analyzed [units: participants]	36	34
Change From Baseline in Cluster Determinant 4 (CD4) Cell Count [units: cells/mm^3] Median ( Inter-Quartile Range )	60.5 ( -6.5 to 159.0 )	9.0 ( -61.0 to 106.0 )

Statistical Analysis 1 for Change From Baseline in Cluster Determinant 4 (CD4) Cell Count

Groups ^[1]	All groups
Method ^[2]	Wilcoxon Rank Sum test
P Value ^[3]	0.0789

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No adjustments were made.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No adjustments for multiple comparisons were made.

10. Secondary:

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

Measure Type	Secondary
Measure Title	Change From Baseline in Fasting Serum Triglycerides
Measure Description	Change = Week 48 value minus baseline value.
Time Frame	Baseline to Week 48
Safety Issue	Yes

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.
Treated participants. Missing values were excluded.

Reporting Groups

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

Measured Values

	Truvada	Zidovudine/Lamivudine
Number of Participants Analyzed [units: participants]	34	31
Change From Baseline in Fasting Serum Triglycerides [units: mg/dL] Median ( Inter-Quartile Range )	1.5 ( -31.0 to 17.0 )	4.0 ( -44.0 to 40.0 )

Statistical Analysis 1 for Change From Baseline in Fasting Serum Triglycerides

Groups ^[1]	All groups
Method ^[2]	Wilcoxon Rank Sum test
P Value ^[3]	0.9633

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No adjustments were made.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No adjustments for multiple comparisons were made.

11. Secondary:

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

Measure Type	Secondary
Measure Title	Change From Baseline in Fasting Total Cholesterol
Measure Description	Change = Week 48 value minus baseline value.
Time Frame	Baseline to Week 48
Safety Issue	Yes

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.
Treated participants. Missing values were excluded.

Reporting Groups

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

Measured Values

	Truvada	Zidovudine/Lamivudine
Number of Participants Analyzed [units: participants]	34	31
Change From Baseline in Fasting Total Cholesterol [units: mg/dL] Median ( Inter-Quartile Range )	4.5 ( -12.0 to 12.0 )	1.0 ( -19.0 to 21.0 )

Statistical Analysis 1 for Change From Baseline in Fasting Total Cholesterol

Groups ^[1]	All groups
Method ^[2]	Wilcoxon Rank Sum test
P Value ^[3]	0.9686

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No adjustments were made.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No adjustments for multiple comparisons were made.

12. Secondary:

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

Measure Type	Secondary
Measure Title	Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL)
Measure Description	Change = Week 48 value minus baseline value.
Time Frame	Baseline to Week 48
Safety Issue	Yes

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.
Treated participants. Missing values were excluded.

Reporting Groups

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

Measured Values

	Truvada	Zidovudine/Lamivudine
Number of Participants Analyzed [units: participants]	29	27
Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL) [units: mg/dL] Median ( Inter-Quartile Range )	7.0 ( -9.4 to 15.6 )	5.0 ( -14.0 to 16.0 )

Statistical Analysis 1 for Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL)

Groups ^[1]	All groups
Method ^[2]	Wilcoxon Rank Sum test
P Value ^[3]	0.6638

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No adjustments were made.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No adjustments for multiple comparisons were performed.

13. Secondary:

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

Measure Type	Secondary
Measure Title	Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL)
Measure Description	Change = Week 48 value minus baseline value.
Time Frame	Baseline to Week 48
Safety Issue	Yes

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.
Treated participants. Missing values were excluded.

Reporting Groups

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

Measured Values

	Truvada	Zidovudine/Lamivudine
Number of Participants Analyzed [units: participants]	31	28
Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL) [units: mg/dL] Median ( Inter-Quartile Range )	-2.0 ( -7.0 to 2.0 )	2.0 ( -7.0 to 7.0 )

Statistical Analysis 1 for Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL)

Groups ^[1]	All groups
Method ^[2]	Wilcoxon Rank Sum test
P Value ^[3]	0.2907

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No adjustments were made.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No adjustments for multiple comparisons were made.

14. Secondary:

Change From Baseline in Hemoglobin [ Baseline to Week 48 ]

Measure Type	Secondary
Measure Title	Change From Baseline in Hemoglobin
Measure Description	Change = Week 48 value minus baseline value.
Time Frame	Baseline to Week 48
Safety Issue	Yes

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.
Treated participants. Missing values were excluded.

Reporting Groups

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

Measured Values

	Truvada	Zidovudine/Lamivudine
Number of Participants Analyzed [units: participants]	36	33
Change From Baseline in Hemoglobin [units: g/dL] Median ( Inter-Quartile Range )	0.9 ( 0.0 to 1.2 )	0.3 ( -0.5 to 0.7 )

Statistical Analysis 1 for Change From Baseline in Hemoglobin

Groups ^[1]	All groups
Method ^[2]	Wilcoxon Rank Sum test
P Value ^[3]	0.0072

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No adjustments were made.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No adjustments for multiple comparisons were made.

15. Secondary:

Change From Baseline in Hematocrit [ Baseline to Week 48 ]

Measure Type	Secondary
Measure Title	Change From Baseline in Hematocrit
Measure Description	Change = Week 48 value minus baseline value.
Time Frame	Baseline to Week 48
Safety Issue	Yes

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.
Treated participants. Missing values were excluded.

Reporting Groups

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

Measured Values

	Truvada	Zidovudine/Lamivudine
Number of Participants Analyzed [units: participants]	36	33
Change From Baseline in Hematocrit [units: Percent] Median ( Inter-Quartile Range )	2.7 ( 1.5 to 4.3 )	1.0 ( -0.9 to 2.0 )

Statistical Analysis 1 for Change From Baseline in Hematocrit

Groups ^[1]	All groups
Method ^[2]	Wilcoxon Rank Sum test
P Value ^[3]	0.0006

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No adjustments were made.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No adjustments for multiple comparisons were made.

16. Secondary:

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

Measure Type	Secondary
Measure Title	Change From Baseline in Waist Circumference/Hip Circumference Ratio
Measure Description	Change = Week 48 value minus baseline value.
Time Frame	Baseline to Week 48
Safety Issue	Yes

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.
Treated participants. Missing values were excluded. Assessment of waist and hip circumference was added to the study schedule via protocol amendment part way through the study. This resulted in small numbers of subjects having data available for this analysis.

Reporting Groups

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

Measured Values

	Truvada	Zidovudine/Lamivudine
Number of Participants Analyzed [units: participants]	28	25
Change From Baseline in Waist Circumference/Hip Circumference Ratio [units: Ratio] Median ( Inter-Quartile Range )	-0.01 ( -0.03 to 0.02 )	0.01 ( -0.01 to 0.04 )

Statistical Analysis 1 for Change From Baseline in Waist Circumference/Hip Circumference Ratio

Groups ^[1]	All groups
Method ^[2]	Wilcoxon Rank Sum test
P Value ^[3]	0.1785

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No adjustments were made.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No adjustments for multiple comparisons were made.

17. Secondary:

Percentage of Participants With Any Adverse Event [ 72 weeks ]

Measure Type	Secondary
Measure Title	Percentage of Participants With Any Adverse Event
Measure Description	Treatment-emergent adverse events.
Time Frame	72 weeks
Safety Issue	Yes

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.
Treated participants.

Reporting Groups

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

Measured Values

	Truvada	Zidovudine/Lamivudine
Number of Participants Analyzed [units: participants]	39	41
Percentage of Participants With Any Adverse Event [units: Percentage of participants]	77	85

No statistical analysis provided for Percentage of Participants With Any Adverse Event

18. Secondary:

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

Measure Type	Secondary
Measure Title	Percentage of Participants Who Discontinue the Study Prematurely (Before Week 48) Due to Adverse Events.
Measure Description	No text entered.
Time Frame	48 weeks
Safety Issue	Yes

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.
Treated participants.

Reporting Groups

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

Measured Values

	Truvada	Zidovudine/Lamivudine
Number of Participants Analyzed [units: participants]	39	41
Percentage of Participants Who Discontinue the Study Prematurely (Before Week 48) Due to Adverse Events. [units: Percentage of participants]	3	10

No statistical analysis provided for Percentage of Participants Who Discontinue the Study Prematurely (Before Week 48) Due to Adverse Events.

Responsible Party:	Gilead Sciences ( Pedro Ferrer )
Study ID Numbers:	GS-ES-164-0154
Study First Received:	May 9, 2006
Results First Received:	March 30, 2009
Last Updated:	November 20, 2009
ClinicalTrials.gov Identifier:	NCT00324649 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines