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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002104
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: July 1998
History of Changes
  Purpose

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.


Condition Intervention Phase
Mycobacterium Avium-Intracellulare Infection
HIV Infections
Tuberculosis, Mycobacterium Infection
 Drug: Thalidomide
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Placebo-Controlled Trial of Safety and Efficacy of Thalidomide in Patients With Infections Due to Mycobacterium and/or HIV

Resource links provided by NLM:

Drug Information available for: Thalidomide
U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002104

Locations
United States, New York
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
New York, New York, United States, 10021
Bellevue Hosp Ctr
New York, New York, United States, 10016
Sponsors and Collaborators
Aaron Diamond AIDS Research Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002104     History of Changes
Other Study ID Numbers: 133A
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Mycobacterium tuberculosis
Mycobacterium Infections
AIDS-Related Opportunistic Infections
Mycobacterium avium-intracellulare Infection
 Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Mycobacterium Infections, Atypical
Thalidomide

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Mycobacterium Infections
Mycobacterium avium-intracellulare Infection
Tuberculosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Actinomycetales Infections
 Gram-Positive Bacterial Infections
Bacterial Infections
Mycobacterium Infections, Atypical
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances

ClinicalTrials.gov processed this record on March 03, 2013