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

National Center for Research Resources (NCRR)

Status and phase: Completed; Phase 2

Conditions: Tuberculosis; Mycobacterium Infections; HIV Infections

Treatments: Drug: thalidomide

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00004276

199/11682

RU-0300395

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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