Trial | NCT00004276  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    50
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 Started
Sep 30
1990
Study Completion
Jun 30
1999
Last Update
Jun 24
2005
Estimate

Drug 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
No Results Posted