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Keep this study
Lead
National Center for Research Resources (NCRR)
With
National Institute of Allergy and Infectious Diseases (NIAID)
Rockefeller University
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.
Age
18–65
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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