Phase II Placebo Controlled Study of Thalidomide in Patients With Mycobacterial and HIV Infections

Sponsor
National Center for Research Resources (NCRR) (NIH)
Overall Status
Completed
CT.gov ID
NCT00004276
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) (NIH), Rockefeller University (Other)
50
105

Study Details

Study Description

Brief Summary

OBJECTIVES: I. Evaluate whether thalidomide modulates toxic host inflammatory responses in patients receiving antitubercular therapy.

  1. Evaluate whether thalidomide modifies tumor necrosis factor-mediated toxic symptoms of HIV and mycobacterial infections, and limits progression of HIV immunodeficiency.

  2. Evaluate whether thalidomide stimulates immunity in patients with HIV and/or mycobacterial infections.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

PROTOCOL OUTLINE: This is a randomized, double blind study. Patients are stratified by type of infection.

Patients are randomly assigned to oral thalidomide or placebo. Therapy is administered daily for up to 8 weeks, beginning the night before antitubercular treatment is initiated.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Masking:
Double
Primary Purpose:
Treatment
Study Start Date :
Sep 1, 1990
Study Completion Date :
Jun 1, 1999

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    PROTOCOL ENTRY CRITERIA:

    --Disease Characteristics--

    Human immunodeficiency virus (HIV) or mycobacterial infection that requires at least 10 days of inpatient antitubercular treatment

    Mycobacterial infection confirmed by positive acid-fast bacilli smear or culture for Mycobacterium tuberculosis

    At least 1 of the following signs and symptoms required:
    • Temperature over 38 degrees C on at least 2 occasions within 1 week prior to treatment

    • Weight loss greater than 5 kg

    • Pulmonary involvement in at least 1 lobe on x-ray

    Night sweats on at least 2 occasions within 1 week prior to treatment

    --Prior/Concurrent Therapy--

    Concurrent rifampicin, isoniazid, pyrazinamide, and ethambutol for tuberculosis allowed

    --Patient Characteristics--

    • No neuropathy and not at risk for neuropathy

    • Not pregnant

    • Negative pregnancy test

    • Fertile patients must use effective contraception during and for 4 weeks after study

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • National Center for Research Resources (NCRR)
    • National Institute of Allergy and Infectious Diseases (NIAID)
    • Rockefeller University

    Investigators

    • Study Chair: Gilla Kaplan, Rockefeller University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00004276
    Other Study ID Numbers:
    • 199/11682
    • RU-0300395
    First Posted:
    Oct 19, 1999
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Dec 1, 2001

    Study Results

    No Results Posted as of Jun 24, 2005