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 enrollmentJuly 2005

ConditionsHIV-Associated Lipodystrophy Syndrome

InterventionsAtazanavir (ATV) + ritonavir (RTV), continuation of backbone 2 nucleoside reverse transcriptase inhibitor (NRTIs)continuation of current HAART (boosted protease inhibitor [PI] combination + 2 NRTIs)

DrugsAtazanavir (ATV) + ritonavir (RTV), continuation of backbone 2 nucleoside reverse transcriptase inhibitor (NRTIs)continuation of current HAART (boosted protease inhibitor [PI] combination + 2 NRTIs)

Overview

Phase: Phase 4
Intervention: Atazanavir (ATV) + ritonavir (RTV), continuation of backbone 2 nucleoside reverse transcriptase inhibitor (NRTIs)
Conditions: HIV-Associated Lipodystrophy Syndrome
Sponsor: Bristol-Myers Squibb
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
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

July 2005

End Date

June 2008

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Eligibility Criteria

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

Intervention: Atazanavir (ATV) + ritonavir (RTV), continuation of backbone 2 nucleoside reverse transcriptase inhibitor (NRTIs)

Control Arm

Intervention: continuation of current HAART (boosted protease inhibitor [PI] combination + 2 NRTIs)

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)