The Effects of r-metHuIFN-Gamma on the Lungs of Patients With AIDS

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

12 participants

Study Classification

INTERVENTIONAL

Brief Summary

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To determine safety and tolerance of administering aerosolized recombinant interferon gamma (IFN-gamma) for 4 weeks in patients with AIDS. To examine activation of alveolar macrophages by aerosolized IFN-gamma administration. To determine if subcutaneous (SC) injection of IFN-gamma can activate alveolar macrophages in AIDS patients.

Detailed Description

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Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Interferon gamma-1b

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients must have:

* Diagnosis of AIDS with one or more opportunistic infections.
* Kaposi's sarcoma with prior history of opportunistic infection.
* Stable dose of zidovudine (AZT) therapy.
* Preserved pulmonary, renal and hepatic function.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Presence of active infection.
* Active opportunistic infections.
* Cardiac disease.
* Central nervous system disorders.
* History of seizures.
* Irreversible airway disease.

Patients with the following are excluded:

* Co-existing conditions and symptoms listed in Patient Exclusion Co-existing Conditions.

Prior Medication:

Excluded within 4 weeks of study entry:

* Immunosuppressive therapy.
* Cytotoxic therapy.
* Excluded:
* Interferon gamma therapy.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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-8901

Identifier Type: -

Identifier Source: secondary_id

062A