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

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:	NCT00002433

Purpose

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.

Condition	Intervention
HIV Infections	Drug: Interferon gamma-1b

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Primary Purpose: Treatment
Official Title:	Activation of Alveolar Macrophages by Aerosolized r-metHuIFN-Gamma (IFN-Gamma) in Patients With AIDS

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: 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 to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002433

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:	NCT00002433 History of Changes
Other Study ID Numbers:	062A, IFNG-8901
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:

Pulmonary Alveoli
Macrophage Activation
Interferon-gamma, Recombinant

Injections, Subcutaneous
Aerosols
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
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
Interferon-gamma
Interferon-gamma, Recombinant
Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 09, 2012