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Study Results
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Peripheral Body Fat Distribution After Switching Zidovudine and Lamivudine to Truvada (RECOMB)
This study has been completed.
Study NCT00324649   Information provided by Gilead Sciences
First Received: May 9, 2006   Last Updated: March 30, 2009   History of Changes
Study Type: Interventional
Study Design: Randomized, Open Label, Active Control, Parallel Assignment
Condition: HIV-1
Interventions: Drug: Truvada
Drug: AZT/3TC

  Participant Flow
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  Baseline Characteristics
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Reporting Groups
  Description
TVD Truvada + NNRTI or PI.
AZT/3TC AZT/3TC + NNRTI or PI.

Baseline Measures
  TVD AZT/3TC 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, Customized  
[units: Participants]
     
White 36 38 74
Black, of African heritage 1 2 3
Asian 1 0 1
Other (South American) 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: 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   [ Week 48 ]

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

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

4.  Secondary:   Change From Baseline in Lactate Concentration   [ 48 weeks ]

5.  Secondary:   Percentage of Days for Which Participants Were Compliant With Study Drug   [ 72 weeks ]

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

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

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

9.  Secondary:   Change From Baseline in Cluster Determinant 4 (CD4) Cell Count   [ 48 weeks ]

10.  Secondary:   Change From Baseline in Fasting Serum Triglycerides   [ 48 weeks ]

11.  Secondary:   Change From Baseline in Fasting Total Cholesterol   [ 48 weeks ]

12.  Secondary:   Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL)   [ 48 weeks ]

13.  Secondary:   Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL)   [ 48 weeks ]

14.  Secondary:   Change From Baseline in Hemoglobin   [ 48 weeks ]

15.  Secondary:   Change From Baseline in Hematocrit   [ 48 weeks ]

16.  Secondary:   Change From Baseline in Waist Circumference/Hip Circumference Ratio   [ 48 weeks ]

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

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


  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:
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.


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: March 30, 2009
ClinicalTrials.gov Identifier: NCT00324649     History of Changes
Health Authority: Spain: Spanish Agency of Medicines