Placebo-Controlled Trial of Safety and Efficacy of Thalidomide in Patients With Infections Due to Mycobacterium and/or HIV
To demonstrate, in patients with tubercular or nontubercular mycobacterium infections with or without HIV infection, the safety of thalidomide use as judged by symptoms, physical exam, and studies of microbiologic, immunologic, hematologic, renal, and hepatic status. To demonstrate efficacy of the drug as judged by status of fever, nutrition, tuberculosis lesions, and immune responses.
Mycobacterium Avium-Intracellulare Infection
Tuberculosis, Mycobacterium Infection
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Placebo-Controlled Trial of Safety and Efficacy of Thalidomide in Patients With Infections Due to Mycobacterium and/or HIV|
Patients are randomized to receive thalidomide or placebo orally at 9 PM the night before beginning anti-tuberculosis chemotherapy and continuing nightly for 7 nights. Patients are followed for 28 days. Patients are stratified according to HIV status and stage of HIV infection.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002104
|United States, New York|
|Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ|
|New York, New York, United States, 10021|
|Bellevue Hosp Ctr|
|New York, New York, United States, 10016|