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OpenTrials
Completed

NCT Number: NCT00002433

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

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.

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Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York Hosp - Cornell Med Ctr

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Interferon gamma-1b

Drug

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

First posted
Aug 31, 2001
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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