Study of Reyataz in HIV-infected Patients With Lipodystrophy Syndrome

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00135356
First received: August 25, 2005
Last updated: April 20, 2010
Last verified: April 2010
Results First Received: December 15, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV-Associated Lipodystrophy Syndrome
Interventions: Drug: Atazanavir (ATV) + ritonavir (RTV), continuation of backbone 2 nucleoside reverse transcriptase inhibitor (NRTIs)
Drug: continuation of current HAART (boosted protease inhibitor [PI] combination + 2 NRTIs)

  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
A total of 219 participants were enrolled and 18 were never randomized (1 poor/noncompliance; 10 no longer met study criteria; 5 withdrew consent). 201 participants were randomized; however, 1 participant was never treated and is not included in the participant flow.

Reporting Groups
  Description
ATV/RTV Switch Arm Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
PI/RTV Control Arm Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.

Participant Flow:   Overall Study
    ATV/RTV Switch Arm     PI/RTV Control Arm  
STARTED     131 [1]   69 [2]
Discontinued Prior to Week 96 Visit     16     9  
Discontinued on or After Week 96 Visit     1     0  
COMPLETED     114     60  
NOT COMPLETED     17     9  
Adverse Event                 6                 2  
Lack of Efficacy                 2                 0  
Lost to Follow-up                 3                 1  
Surgery for abdominal fat                 1                 0  
Change in antiviral regimen                 0                 1  
Poor/noncompliance                 1                 1  
No longer meets study criteria                 2                 0  
Withdrawal by Subject                 2                 4  
[1] Number randomized and treated
[2] Number randomized and treated(1 randomized and never treated subject not included in this number.)



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Trunk-to-limb Fat Ratio as Measured by Dual Energy X-Ray Absortiometry (DEXA) at Week 48   [ Time Frame: Baseline, Week 48 ]

2.  Secondary:   Change From Baseline in Trunk-to-limb Fat Ratio as Measured by DEXA at Week 96   [ Time Frame: Baseline, Week 96 ]

3.  Secondary:   Mean Percent Change From Baseline in Visceral Adipose Tissue (VAT) Area by Computed Tomography (CT) Scans and in Trunk Fat by DEXA.   [ Time Frame: Baseline, Week 48, Week 96 ]

4.  Secondary:   Mean Percent Change From Baseline in Peripheral Adipose Tissue (Limb Fat) by DEXA and by Changes in Subcutaneous Adipose Tissue (SAT) Area by CT Scans   [ Time Frame: Baseline, Week 48, Week 96 ]

5.  Secondary:   Mean Percent Change From Baseline in Total Body Fat by DEXA and in Total Adipose Tissue (TAT) Area by CT Scans   [ Time Frame: Baseline, Week 48, Week 96 ]

6.  Secondary:   Mean Percent Changes From Baseline in Fasting Lipids   [ Time Frame: Baseline, Week 48, Week 96 ]

7.  Secondary:   Mean Changes From Baseline in Fasting Glucose at Week 48 and Week 96   [ Time Frame: Baseline, Week 48, Week 96 ]

8.  Secondary:   Mean Changes From Baseline in Fasting Insulin at Week 48 and Week 96   [ Time Frame: Baseline, Week 48, Week 96 ]

9.  Secondary:   Mean Changes From Baseline in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)   [ Time Frame: Baseline, Week 48, Week 96 ]

10.  Secondary:   Mean Changes From Baseline in Body Weight at Week 48 and Week 96   [ Time Frame: Baseline, Week 48, Week 96 ]

11.  Secondary:   Mean Changes From Baseline in Waist Circumference at Week 48 and Week 96   [ Time Frame: Baseline, Week 48, Week 96 ]

12.  Secondary:   Mean Changes From Baseline in Body Mass Index at Week 48 and Week 96   [ Time Frame: Baseline, Week 48, Week 96 ]

13.  Secondary:   Mean Changes From Baseline in Waist-to-Hip Ratio at Week 48 and Week 96   [ Time Frame: Baseline, Week 48, Week 96 ]

14.  Secondary:   Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation   [ Time Frame: Through Week 96 of study therapy ]

15.  Secondary:   Percentage of Participants With Abnormal Liver Function Tests   [ Time Frame: Week 48, Week 96 ]

16.  Secondary:   Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation   [ Time Frame: Through Week 96 ]

17.  Secondary:   Kaplan-Meier Cumulative Proportion of Participants Without Virologic Rebound (HIV RNA ≥400 c/mL) at Timepoints up to Week 96 in Treated Participants With HIV RNA <400 c/mL at Baseline   [ Time Frame: Weeks 8-12, Weeks 20-24, Weeks 32-36, Weeks 44-48, Weeks 56-60, Weeks 68-72, Weeks 80-84, Weeks 92-96 ]

18.  Secondary:   Mean Change From Baseline in CD4 Count   [ Time Frame: Baseline, Week 48, Week 96 ]


  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