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

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ClinicalTrials.gov Identifier: NCT00324649
Recruitment Status : Completed
First Posted : May 11, 2006
Results First Posted : May 20, 2009
Last Update Posted : August 17, 2015
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

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

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

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 
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) 
[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.
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

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

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.


  More Information