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

Primary Purpose

Mycobacterium Avium-Intracellulare Infection, HIV Infections, Tuberculosis, Mycobacterium Infection

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Thalidomide
Sponsored by
Aaron Diamond AIDS Research Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mycobacterium Avium-Intracellulare Infection focused on measuring Mycobacterium tuberculosis, Mycobacterium Infections, AIDS-Related Opportunistic Infections, Mycobacterium avium-intracellulare Infection, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Mycobacterium Infections, Atypical, Thalidomide

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bellevue Hosp Ctr
  • Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Aaron Diamond AIDS Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT00002104
Brief Title
Placebo-Controlled Trial of Safety and Efficacy of Thalidomide in Patients With Infections Due to Mycobacterium and/or HIV
Official Title
Placebo-Controlled Trial of Safety and Efficacy of Thalidomide in Patients With Infections Due to Mycobacterium and/or HIV
Study Type
Interventional

2. Study Status

Record Verification Date
July 1998
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators

Name of the Sponsor
Aaron Diamond AIDS Research Center

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycobacterium Avium-Intracellulare Infection, HIV Infections, Tuberculosis, Mycobacterium Infection
Keywords
Mycobacterium tuberculosis, Mycobacterium Infections, AIDS-Related Opportunistic Infections, Mycobacterium avium-intracellulare Infection, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Mycobacterium Infections, Atypical, Thalidomide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Thalidomide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Bellevue Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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