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

National Center for Research Resources (NCRR)50 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

HIV Infections Mycobacterium Infections Tuberculosis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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