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

Phase 2

Completed

• Conditions: HIV Infections; Mycobacterium Infections; Tuberculosis

• Registration Number: NCT00004276
• Lead Sponsor: National Center for Research Resources (NCRR)

Brief 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.

Study Timeline

• Study Start: 1990-09
• Study Completion: 1999-06
• Study First Submitted: 1999-10-18
• Study First Submitted QC: 1999-10-18
• Study First Posted: 1999-10-19
• Status Verified: 2001-12
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified