NCT00135356CompletedPhase 4
A Phase IV, Open-Label, Randomized, Multicenter Trial Assessing a Reyataz-Based Substitution Approach in the Management of Lipodystrophy Syndrome. Research Into Atazanavir in Lipodystrophy (The REAL Study)
Bristol-Myers Squibb1 site in 1 country219 target enrollmentStarted: July 2005Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 219
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Trunk-to-limb Fat Ratio as Measured by Dual Energy X-Ray Absortiometry (DEXA) at Week 48
Study Overview
Brief Summary
The purpose of this clinical research study is to learn if human immunodeficiency virus (HIV)-infected subjects with abdominal fat accumulation on their highly active antiretroviral treatment (HAART) regimen have better changes in fat distribution after switching to atazanavir-ritonavir than those remaining on their current protease inhibitor boosted HAART regimen.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •HIV-1 infected on HAART regimen containing 2 NRTI and boosted PI for at least 12 weeks prior to screening. Subjects may not have experienced virological failure to more than one prior PI-containing regimen. Must be able to swallow tablets
- •Viral load <400 c/mL at screening and stable for at least 6 months
- •Signs of fat redistribution and lipohypertrophy (abdominal) Waist to Hip Ratio >0.90 and Waist Circumference >88.2 cm for men and Waist Circumference >75.3 for women
Exclusion Criteria
- •Pregnant or breastfeeding women
- •New HIV-related opportunistic infections
- •Active alcohol or substance use
- •Grade 4 lab toxicity
- •History of taking atazanavir (ATV)
- •Prohibited therapies, including non-nucleoside reverse transcriptase inhibitors (NNRTI)
Arms & Interventions
Switch arm
Active Comparator
Intervention: Atazanavir (ATV) + ritonavir (RTV), continuation of backbone 2 nucleoside reverse transcriptase inhibitor (NRTIs) (Drug)
Control Arm
Active Comparator
Intervention: continuation of current HAART (boosted protease inhibitor [PI] combination + 2 NRTIs) (Drug)
Outcomes
Primary Outcomes
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
Mean changes from Baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement is associated with a decrease in values. (Baseline trunk-to-limb fat ratio values can be found in the Baseline Characteristics section.)
Secondary Outcomes
- Percentage of Participants With Abnormal Liver Function Tests(Week 48, Week 96)
- Mean Change From Baseline in CD4 Count(Baseline, Week 48, Week 96)
- Mean Percent Change From Baseline in Visceral Adipose Tissue (VAT) Area by Computed Tomography (CT) Scans and in Trunk Fat by DEXA.(Baseline, Week 48, Week 96)
- Change From Baseline in Trunk-to-limb Fat Ratio as Measured by DEXA at Week 96(Baseline, Week 96)
- Mean Percent Changes From Baseline in Fasting Lipids(Baseline, Week 48, Week 96)
- Mean Percent Change From Baseline in Total Body Fat by DEXA and in Total Adipose Tissue (TAT) Area by CT Scans(Baseline, Week 48, Week 96)
- Mean Changes From Baseline in Fasting Glucose at Week 48 and Week 96(Baseline, Week 48, Week 96)
- 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(Baseline, Week 48, Week 96)
- Mean Changes From Baseline in Fasting Insulin at Week 48 and Week 96(Baseline, Week 48, Week 96)
- Mean Changes From Baseline in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)(Baseline, Week 48, Week 96)
- Mean Changes From Baseline in Body Weight at Week 48 and Week 96(Baseline, Week 48, Week 96)
- Mean Changes From Baseline in Waist Circumference at Week 48 and Week 96(Baseline, Week 48, Week 96)
- Mean Changes From Baseline in Body Mass Index at Week 48 and Week 96(Baseline, Week 48, Week 96)
- Mean Changes From Baseline in Waist-to-Hip Ratio at Week 48 and Week 96(Baseline, Week 48, Week 96)
- Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation(Through Week 96 of study therapy)
- Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation(Through Week 96)
- 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(Weeks 8-12, Weeks 20-24, Weeks 32-36, Weeks 44-48, Weeks 56-60, Weeks 68-72, Weeks 80-84, Weeks 92-96)
Investigators
Study Sites (1)
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