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: February 22, 2013
Last verified: February 2013
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


  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 ]

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

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

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

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

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

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

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

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

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

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

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

13.  Secondary:   Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL)   [ Time Frame: Baseline to Week 48 ]

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  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


No publications provided


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: February 22, 2013
Health Authority: Spain: Spanish Agency of Medicines