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

Completed · Phase 1

Conditions studied: Mycobacterium Avium-Intracellulare Infection, HIV Infections, Tuberculosis, Mycobacterium Infection

In brief

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.

Key facts

Study ID

NCT00002104

Run by

Aaron Diamond AIDS Research Center

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Bellevue Hosp Ctr — New York, New York, United States
• Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ — New York, New York, United States

Full record on ClinicalTrials.gov

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