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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002433
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
  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: 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:


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

Estimated Enrollment: 12
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00002433     History of Changes
Other Study ID Numbers: 062A
IFNG-8901
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
Last Verified: November 1999

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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Interferons
Interferon-gamma
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents


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