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)

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.

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)