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Evaluation of the Therapeutic Benefit of r-metHuIFN- Gamma in AIDS Patients With Disseminated Mycobacterium Avium-Intracellulare (MAI) Infection: A Multi-Centered Pilot Study

This study has been completed.

Sponsored by: Amgen
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002037
  Purpose

To examine the effectiveness of subcutaneous gamma interferon in reducing severity of Mycobacterium avium- intracellulare (MAI) bacillemia episodes in AIDS patients in an open-label dose-randomized multi-center pilot clinical investigation. To evaluate the safety of gamma interferon given by subcutaneous injection (SC) in the AIDS patient in the presence and absence of AZT therapy.


Condition Intervention
Mycobacterium Avium-Intracellulare Infection
HIV Infections
Drug: Trifluridine

MedlinePlus related topics:   AIDS   

Drug Information available for:   Interferon alfa-2b    Interferons    Interferon gamma-1b    Trifluridine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Safety Study
Official Title:   Evaluation of the Therapeutic Benefit of r-metHuIFN- Gamma in AIDS Patients With Disseminated Mycobacterium Avium-Intracellulare (MAI) Infection: A Multi-Centered Pilot Study

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

Estimated Enrollment:   15

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

Patients must have:

  • Diagnosis of AIDS and persistent Mycobacterium avium- intracellulare (MAI) bacillemia.
  • Life expectancy of at least 3 months.
  • Baseline chest X-ray and EKG (electrocardiogram).

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Known hypersensitivity to interferons or other exogenous lymphokine.
  • History of cardiac abnormality or disease.
  • History of hypertension.

Patients with the following are excluded:

  • Known hypersensitivity to interferons or other exogenous lymphokine.
  • History of cardiac abnormality or disease.
  • History of hypertension.

Prior Medication:

Excluded within 4 weeks of study entry:

  • Corticosteroids.
  • Anti-inflammatory medication (except aspirin).
  • Changes in the dose of anti-mycobacterial drugs.
  • Immune agents.

Prior Treatment:

Excluded within 4 weeks of study entry:

  • Radiotherapy.

Risk Behavior:

Excluded:

  • Intravenous drug abuse.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002037

Locations
United States, New York
New York Hosp - Cornell Med Ctr    
      New York, New York, United States, 10021

Sponsors and Collaborators
Amgen
  More Information


Study ID Numbers:   062B, IFNG-8701
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002037
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections  
Mycobacterium avium-intracellulare Infection  
Interferon-gamma, Recombinant  
Acquired Immunodeficiency Syndrome  

Study placed in the following topic categories:
Bacterial Infections
Opportunistic Infections
Sexually Transmitted Diseases, Viral
Interferon Type II
Interferons
Acquired Immunodeficiency Syndrome
Mycobacterium Infections, Atypical
Immunologic Deficiency Syndromes
Trifluridine
Mycobacterium avium-intracellulare Infection
Virus Diseases
Gram-Positive Bacterial Infections
HIV Infections
AIDS-Related Opportunistic Infections
Sexually Transmitted Diseases
Mycobacterium Infections
Mycobacterium avium complex infection
Interferon Alfa-2b
Retroviridae Infections
Interferon-gamma, Recombinant

Additional relevant MeSH terms:
Antimetabolites
Communicable Diseases
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Infection
Antiviral Agents
Actinomycetales Infections
Pharmacologic Actions
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on November 30, 2008




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