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

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

MedlinePlus related topics:

AIDS

ChemIDplus related topics:

Interferon alfa-2b Interferons Interferon gamma-1b

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Safety Study

Official Title:	Activation of Alveolar Macrophages by Aerosolized r-metHuIFN-Gamma (IFN-Gamma) in Patients With AIDS

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

Estimated Enrollment:

12

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

Study ID Numbers:	062A, IFNG-8901
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002433
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

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

Interferon Type II

HIV Infections

Interferons

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Interferon Alfa-2b

Retroviridae Infections

Immunologic Deficiency Syndromes

Interferon-gamma, Recombinant

Additional relevant MeSH terms:

Anti-Infective Agents

RNA Virus Infections

Slow Virus Diseases

Immune System Diseases

Antineoplastic Agents

Therapeutic Uses

Lentivirus Infections

Infection

Antiviral Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2008

Sponsored by:	Amgen
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002433