Placebo-Controlled Trial of Safety and Efficacy of Thalidomide in Patients With Infections Due to Mycobacterium and/or HIV
Mycobacterium Avium-Intracellulare Infection, HIV Infections, Tuberculosis, Mycobacterium Infection
About this trial
This is an interventional treatment trial for Mycobacterium Avium-Intracellulare Infection focused on measuring Mycobacterium tuberculosis, Mycobacterium Infections, AIDS-Related Opportunistic Infections, Mycobacterium avium-intracellulare Infection, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Mycobacterium Infections, Atypical, Thalidomide
Eligibility Criteria
Inclusion Criteria Patients must have: Positive AFB smear and/or culture for Mycobacterium tuberculosis, M. avium, or other mycobacterial infection, with or without documented HIV infection. NOTE: HIV-positive patients must have CD4 count < 500 cells/mm3 and be on antiretroviral therapy. One of the following manifestations: Temperature over 38 C on at least two occasions in the week prior to study entry. Recent weight loss of more than 5 kilograms. Pulmonary involvement of one or more lobes or involvement of other tissues due to tuberculosis or other mycobacterial infections, or symptomatic infections related to HIV status. Night sweats on two or more occasions in the week prior to study entry. NOTE: Patients must be hospitalized men aged 18-65 and postmenopausal women to age 65. Anticipated requirement for hospitalization must be at least 10 days. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Neuropathy or other disorders with risk of neuropathy. Required for HIV-positive patients if CD4 count < 500 cells/mm3: Antiretroviral therapy.
Sites / Locations
- Bellevue Hosp Ctr
- Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ