Phase II Placebo Controlled Study of Thalidomide in Patients With Mycobacterial and HIV Infections
NCT00004276 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2005-06-24
Summary
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.
Conditions
- HIV Infections
- Mycobacterium Infections
- Tuberculosis
Interventions
- DRUG
-
thalidomide
Sponsors & Collaborators
-
National Institute of Allergy and Infectious Diseases (NIAID)
collaborator NIH -
Rockefeller University
collaborator OTHER -
National Center for Research Resources (NCRR)
lead NIH
Principal Investigators
-
Gilla Kaplan · Rockefeller University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 1990-09-30
- Completion
- 1999-06-30
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