Status:
COMPLETED
Study of Reyataz in HIV-infected Patients With Lipodystrophy Syndrome
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
HIV-Associated Lipodystrophy Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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) ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT00135356
Start Date
July 1 2005
End Date
June 1 2008
Last Update
May 7 2010
Active Locations (30)
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1
Local Institution
Fort Lauderdale, Florida, United States
2
Local Institution
Honolulu, Hawaii, United States
3
Local Institution
Huntersville, North Carolina, United States
4
Local Institution
Houston, Texas, United States