Placebo-Controlled Trial of Safety and Efficacy of Thalidomide in Patients With Infections Due to Mycobacterium and/or HIV

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.