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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00324649
First received: May 9, 2006
Last updated: August 13, 2015
Last verified: August 2015
History of Changes
Results First Received: March 30, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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
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
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.
No text entered.

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  
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 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)  
[1] Measured using dual-energy x-ray absorptiometry (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   [ Time Frame: Baseline to Week 48 ]
  Show Outcome Measure 1

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 ]
  Show Outcome Measure 6

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 ]
  Show Outcome Measure 8

9.  Secondary:   Change From Baseline in Cluster Determinant 4 (CD4) Cell Count   [ Time Frame: Baseline to Week 48 ]
  Show Outcome Measure 9

10.  Secondary:   Change From Baseline in Fasting Serum Triglycerides   [ Time Frame: Baseline to Week 48 ]
  Show Outcome Measure 10

11.  Secondary:   Change From Baseline in Fasting Total Cholesterol   [ Time Frame: Baseline to Week 48 ]
  Show Outcome Measure 11

12.  Secondary:   Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL)   [ Time Frame: Baseline to Week 48 ]
  Hide Outcome Measure 12

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 method 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)   [ Time Frame: Baseline to Week 48 ]
  Show Outcome Measure 13

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 ]
  Show Outcome Measure 15

16.  Secondary:   Change From Baseline in Waist Circumference/Hip Circumference Ratio   [ Time Frame: Baseline to Week 48 ]
  Show Outcome Measure 16

17.  Secondary:   Percentage of Participants With Any Adverse Event   [ Time Frame: 72 weeks ]
  Show Outcome Measure 17

18.  Secondary:   Percentage of Participants Who Discontinue the Study Prematurely (Before Week 48) Due to Adverse Events.   [ Time Frame: 48 weeks ]
  Show Outcome Measure 18


  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:
unchecked 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.
unchecked 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.


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
Study First Received: May 9, 2006
Results First Received: March 30, 2009
Last Updated: August 13, 2015
Health Authority: Spain: Spanish Agency of Medicines