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Completed

NCT Number: NCT00002104

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.

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Key information

Conditions

Mycobacterium Avium-intracellulare Infection AIDS-Related Complex AIDS-Related Opportunistic Infections Acquired Immunodeficiency Syndrome Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Communicable Diseases Genital Diseases Gram-Positive Bacterial Infections HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mycobacterium Infections Mycobacterium Infections, Nontuberculous Opportunistic Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Tuberculosis Tuberculosis, Mycobacterium Infection Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

thalidomide

Drug

Sponsors and collaborators

Lead sponsor

Aaron Diamond AIDS Research Center

Other

Registry information

Important dates

First posted
Aug 31, 2001
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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