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

• Status: Completed
• Trial end date: 1999-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Center for Research Resources (NCRR)
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); Rockefeller University
• Treatments: Thalidomide

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Human immunodeficiency virus (HIV) or mycobacterial infection that requires at least 10 days of inpatient antitubercular treatment

Mycobacterial infection confirmed by positive acid-fast bacilli smear or culture for Mycobacterium tuberculosis

At least 1 of the following signs and symptoms required:

• Temperature over 38 degrees C on at least 2 occasions within 1 week prior to treatment

• Weight loss greater than 5 kg

• Pulmonary involvement in at least 1 lobe on x-ray

Night sweats on at least 2 occasions within 1 week prior to treatment

--Prior/Concurrent Therapy--

Concurrent rifampicin, isoniazid, pyrazinamide, and ethambutol for tuberculosis allowed

--Patient Characteristics--

• No neuropathy and not at risk for neuropathy

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 4 weeks after study