Placebo-Controlled Trial of Safety and Efficacy of Thalidomide in Patients With Infections Due to Mycobacterium and/or HIV
Placebo-Controlled Trial of Safety and Efficacy of Thalidomide in Patients With Infections Due to Mycobacterium and/or HIV
To demonstrate, in patients with tubercular or nontubercular mycobacterium infections with or
 without HIV infection, the safety of thalidomide use as judged by symptoms, physical exam,
 and studies of microbiologic, immunologic, hematologic, renal, and hepatic status. To
 demonstrate efficacy of the drug as judged by status of fever, nutrition, tuberculosis
 lesions, and immune responses.
Patients are randomized to receive thalidomide or placebo orally at 9 PM the night before
 beginning anti-tuberculosis chemotherapy and continuing nightly for 7 nights. Patients are
 followed for 28 days. Patients are stratified according to HIV status and stage of HIV
 infection.
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.