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Home > "P" Clinical Trials Conditions > 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
Phase II Placebo Controlled Study of Thalidomide in Patients With Mycobacterial and HIV Infections
For Condition: HIV Infections,Mycobacterium Infections,Tuberculosis
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , National Institute of Allergy and Infectious Diseases (NIAID),Rockefeller University
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 50
Location and Contact Information:
Overall Study Official:
GillaKaplan, Study Chair, Rockefeller University
Additional Information:
Study ID Numbers: 199/11682; RU-0300395
Study Start Date: September 1990
Record last reviewed: December 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004276
Other Hiv Infections Studies:
1. Phase II Placebo Controlled Study of Thalidomide in Patients With Mycobacterial and HIV Infections
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Phase II Placebo Controlled Study of Thalidomide in Patients With Mycobacterial and HIV Infections
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