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