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)

NCT00135356 Phase 4 COMPLETED Results posted

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.

Details

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 4
Status	COMPLETED
Enrolment	219
Start date	2005-07
Completion	2008-06

Conditions

• HIV-Associated Lipodystrophy Syndrome

Interventions

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

Primary outcomes

• Change From Baseline in Trunk-to-limb Fat Ratio as Measured by Dual Energy X-Ray Absortiometry (DEXA) at Week 48 — 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.)

Countries

United States, Canada, France, Germany, Italy, Mexico, Poland, Spain, United Kingdom