Trials / Completed
CompletedNCT00002127
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 75 (planned)
- Sponsor
- Celgene Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Thalidomide |
Timeline
- First posted
- 2001-08-31
- Last updated
- 2005-06-24
Locations
13 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00002127. Inclusion in this directory is not an endorsement.