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.

First Received on November 2, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Masking: 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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS Mycobacterial Infections

Drug Information available for: Trifluridine Interferon gamma-1b Gamma Rays Interferons

U.S. FDA Resources

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

Estimated Enrollment:

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00002037 History of Changes
Other Study ID Numbers:	062B, IFNG-8701
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:

AIDS-Related Opportunistic Infections
Mycobacterium avium-intracellulare Infection
Interferon-gamma, Recombinant
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
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
Slow Virus Diseases
Actinomycetales Infections

Gram-Positive Bacterial Infections
Bacterial Infections
Mycobacterium Infections, Atypical
Interferon-gamma, Recombinant
Interferon-gamma
Trifluridine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012