NCT00004276

Phase II Placebo Controlled Study of Thalidomide in Patients With Mycobacterial and HIV Infections

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (planned)
• Sponsor: National Center for Research Resources (NCRR) · NIH
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• HIV Infections
• Mycobacterium Infections
• Tuberculosis

Interventions

Type	Name	Description
DRUG	thalidomide

Timeline

• Start date: 1990-09-01
• Completion: 1999-06-01
• First posted: 1999-10-19
• Last updated: 2005-06-24