Phase II Placebo Controlled Study of Thalidomide in Patients With Mycobacterial and HIV Infections
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|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)|
|Enrollment :||50 participants|
|Study Start Date :||September 1990|
|Study Completion Date :||June 1999|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004276
|Study Chair:||Gilla Kaplan||Rockefeller University|