Study of Reyataz in HIV-infected Patients With Lipodystrophy Syndrome

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 4

Conditions

HIV-Associated Lipodystrophy Syndrome

Treatments

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

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00135356

AI424-131

Details and patient eligibility

About

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.

Enrollment

219 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)