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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002037
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
  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

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Estimated Enrollment: 15
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00002037     History of Changes
Other Study ID Numbers: 062B
IFNG-8701
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
Last Verified: May 1991

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Mycobacterium Infections
Mycobacterium avium-intracellulare Infection
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Mycobacterium Infections, Nontuberculous
Trifluridine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents