Study of Reyataz in HIV-infected Patients With Lipodystrophy Syndrome

Completed · Phase 4

Conditions studied: HIV-Associated Lipodystrophy Syndrome

In brief

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.

Key facts

Study ID

NCT00135356

Run by

Bristol-Myers Squibb

People needed

219

Starts

2005-07-01

Expected to finish

2008-06-01

Last updated by the study team

2010-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Local Institution — Fort Lauderdale, Florida, United States
• Local Institution — Honolulu, Hawaii, United States
• Local Institution — Huntersville, North Carolina, United States
• Local Institution — Houston, Texas, United States
• Local Institution — Ottawa, Ontario, Canada
• Local Institution — Toronto, Ontario, Canada
• Local Institution — Bondy, France
• Local Institution — Lagny-sur-Marne, France
• Local Institution — Lyon, France
• Local Institution — Nice, France
• Local Institution — Paris, France
• Local Institution — Frankfurt am Main, Germany
• Local Institution — München, Germany
• Local Institution — Brescia, Italy
• Local Institution — Milan, Italy
• Local Institution — Modena, Italy
• Local Institution — Roma, Italy
• Local Institution — Guadalajara, Jalisco, Mexico
• Local Institution — Zapopan, Jalisco, Mexico
• Local Institution — Puebla City, Mexico
• Local Institution — Szczecin, Poland
• Local Institution — Wroclaw, Poland
• Local Institution — Barcelona, Spain
• Local Institution — Elche (Alicante), Spain
• Local Institution — Guipuzcoa, Spain

Full record on ClinicalTrials.gov

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