NCT00135356

Study of Reyataz in HIV-infected Patients With Lipodystrophy Syndrome

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV-Associated Lipodystrophy Syndrome

Interventions

Type	Name	Description
DRUG	Atazanavir (ATV) + ritonavir (RTV), continuation of backbone 2 nucleoside reverse transcriptase inhibitor (NRTIs)	Capsules, Oral, ATV 300 mg + RTV 100 mg once daily up to 96 weeks
DRUG	continuation of current HAART (boosted protease inhibitor [PI] combination + 2 NRTIs)	Protease inhibitor \[PI\] combination + 2 NRTIs

Timeline

• Start date: 2005-07-01
• Primary completion: 2007-07-01
• Completion: 2008-06-01
• First posted: 2005-08-26
• Last updated: 2010-05-07
• Results posted: 2010-05-07

Locations

30 sites across 9 countries: United States, Canada, France, Germany, Italy, Mexico, Poland, Spain, United Kingdom