Peripheral Body Fat Distribution After Switching Zidovudine and Lamivudine to Truvada (RECOMB)

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition:	HIV-1
Interventions:	Drug: Truvada; Drug: Zidovudine/lamivudine

  Participant Flow

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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

  Baseline Characteristics

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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.
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Reporting Groups

	Description
Truvada	Truvada + NNRTI or PI.
Zidovudine/Lamivudine	Zidovudine/lamivudine + NNRTI or PI.
Total	Total of all reporting groups

Baseline Measures

	Truvada	Zidovudine/Lamivudine	Total
Overall Participants Analyzed; [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 zidovudine (AZT)/lamivudine (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)

  Outcome Measures

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

Change From Baseline in Lactate Concentration [ Time Frame: Baseline to Week 48 ]

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

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

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8. Secondary:

Percentage of Participants With Virologic Failure [ Time Frame: 48 weeks ]

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9. Secondary:

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

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10. Secondary:

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

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11. Secondary:

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

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12. Secondary:

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

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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

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
Participants Analyzed	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
Statistical Test Type [2]	Superiority or Other
Statistical Method [3]	Wilcoxon Rank Sum test
P Value [4]	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]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	No text entered.
[3]	Other relevant method information, such as adjustments or degrees of freedom:
	No adjustments were made.
[4]	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) [ Time Frame: Baseline to Week 48 ]

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14. Secondary:

Change From Baseline in Hemoglobin [ Time Frame: Baseline to Week 48 ]

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15. Secondary:

Percent Change From Baseline in Hematocrit [ Time Frame: Baseline to Week 48 ]

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16. Secondary:

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

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17. Secondary:

Percentage of Participants With Any Adverse Event [ Time Frame: 72 weeks ]

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18. Secondary:

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

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  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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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
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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.

Results Point of Contact:  

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

Responsible Party:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00324649 History of Changes
Other Study ID Numbers:	GS-ES-164-0154
First Submitted:	May 9, 2006
First Posted:	May 11, 2006
Results First Submitted:	March 30, 2009
Results First Posted:	May 20, 2009
Last Update Posted:	August 17, 2015