Study of Reyataz in HIV-infected Patients With Lipodystrophy Syndrome

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Atazanavir Sulfate; HIV Protease Inhibitors; Protease Inhibitors; Reverse Transcriptase Inhibitors; Ritonavir

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)