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

Phase 2

Completed

• Conditions: HIV Infections; HIV 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.

Study Timeline

• Status Verified: 1997-07
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (13)

Marin County Specialty Clinic; 🇺🇸 Greenbrae, California, United States

Gottlieb Med Group; 🇺🇸 Sherman Oaks, California, United States

George Washington Univ Med Ctr; 🇺🇸 Washington, District of Columbia, United States

Rockefeller Univ; 🇺🇸 New York, New York, United States

Community Research Initiative of South Florida; 🇺🇸 Coral Gables, Florida, United States

Kansas City AIDS Research Consortium; 🇺🇸 Kansas City, Missouri, United States

AIDS Community Research Consortium; 🇺🇸 Redwood City, California, United States

UCSD Med Ctr - Owen Clinic; 🇺🇸 San Diego, California, United States

Thomas Jefferson Med College; 🇺🇸 Philadelphia, Pennsylvania, United States

Advanced Research Management; 🇺🇸 Seattle, Washington, United States

San Francisco Gen Hosp; 🇺🇸 San Francisco, California, United States

Kaiser Permanente Med Ctr; 🇺🇸 San Francisco, California, United States

Saint Michael's Med Ctr; 🇺🇸 Newark, New Jersey, United States