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

Launched by AARON DIAMOND AIDS RESEARCH CENTER · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Gender

ALL

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.