Phase II Placebo Controlled Study of Thalidomide in Patients With Mycobacterial and HIV Infections
|ClinicalTrials.gov Identifier: NCT00004276|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
OBJECTIVES: I. Evaluate whether thalidomide modulates toxic host inflammatory responses in patients receiving antitubercular therapy.
II. Evaluate whether thalidomide modifies tumor necrosis factor-mediated toxic symptoms of HIV and mycobacterial infections, and limits progression of HIV immunodeficiency.
III. Evaluate whether thalidomide stimulates immunity in patients with HIV and/or mycobacterial infections.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections Mycobacterium Infections Tuberculosis||Drug: thalidomide||Phase 2|
PROTOCOL OUTLINE: This is a randomized, double blind study. Patients are stratified by type of infection.
Patients are randomly assigned to oral thalidomide or placebo. Therapy is administered daily for up to 8 weeks, beginning the night before antitubercular treatment is initiated.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Study Start Date :||September 1990|
|Estimated Study Completion Date :||June 1999|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004276
|Study Chair:||Gilla Kaplan||Rockefeller University|