A Phase II, Parallel Group, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Thalidomide in Reducing Weight Loss in Adults With HIV Wasting Syndrome
- Conditions
- HIV InfectionsHIV Wasting Syndrome
- Registration Number
- NCT00002127
- Lead Sponsor
- Celgene Corporation
- Brief Summary
To evaluate the safety, antiviral and anti-TNF-alpha activity, and preliminary efficacy of thalidomide in reducing weight loss in patients with HIV wasting syndrome.
- Detailed Description
Patients are randomized to receive either thalidomide at 1 of 2 doses or placebo for 8 weeks. Patients who respond may continue in double-blinded treatment for an additional 4 weeks; nonresponding patients may receive thalidomide for up to 4 weeks. Per amendment, patients may receive thalidomide for more than 12 weeks on a compassionate basis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
Marin County Specialty Clinic
🇺🇸Greenbrae, California, United States
AIDS Community Research Consortium
🇺🇸Redwood City, California, United States
UCSD Med Ctr - Owen Clinic
🇺🇸San Diego, California, United States
San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Kaiser Permanente Med Ctr
🇺🇸San Francisco, California, United States
Gottlieb Med Group
🇺🇸Sherman Oaks, California, United States
George Washington Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Community Research Initiative of South Florida
🇺🇸Coral Gables, Florida, United States
Kansas City AIDS Research Consortium
🇺🇸Kansas City, Missouri, United States
Saint Michael's Med Ctr
🇺🇸Newark, New Jersey, United States
Scroll for more (3 remaining)Marin County Specialty Clinic🇺🇸Greenbrae, California, United States