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

	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

Baseline Characteristics

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

Outcome Measures

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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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 ]

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8. Secondary:

Percentage of Participants With Virologic Failure [ 48 weeks ]

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9. Secondary:

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

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10. Secondary:

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

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11. Secondary:

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

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12. Secondary:

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

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13. Secondary:

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

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14. Secondary:

Change From Baseline in Hemoglobin [ Baseline to Week 48 ]

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15. Secondary:

Change From Baseline in Hematocrit [ Baseline to Week 48 ]

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16. Secondary:

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

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17. Secondary:

Percentage of Participants With Any Adverse Event [ 72 weeks ]

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18. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

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:

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other scholarly media only after the following conditions have been met:

The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
The study has been completed at all study sites for at least 2 years.

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: Pedro Ferrer
Organization: Gilead Sciences
phone: +34 91 771 2478
e-mail: pedro.ferrer@gilead.com

No publications provided

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