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

This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service Identifier:
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1999
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:

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

Estimated Enrollment: 12

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00002433

United States, New York
New York Hosp - Cornell Med Ctr
New York, New York, United States, 10021
Sponsors and Collaborators
  More Information 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
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
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents processed this record on October 27, 2016