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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Mycobacterium Avium-Intracellulare Infection HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Trifluridine

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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New York Hosp - Cornell Med Ctr

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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IFNG-8701

Identifier Type: -

Identifier Source: secondary_id

062B