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

This study has been completed.
Study NCT00002433.   Last updated on June 23, 2005.   Information provided by NIH AIDS Clinical Trials Information Service

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Descriptive Information Fields
Brief Title  The Effects of r-metHuIFN-Gamma on the Lungs of Patients With AIDS
Official Title  Activation of Alveolar Macrophages by Aerosolized r-metHuIFN-Gamma (IFN-Gamma) in Patients With AIDS
Brief Summary

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.

Detailed Description
Study Phase
Study Type  Interventional
Study Design  Treatment, Safety Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  HIV Infections
Intervention  Drug: Interferon gamma-1b
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  12
Start Date 
Completion Date
Eligibility 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.
Gender Both
Ages 18 Years to 65 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00002433
Organization ID 062A
Secondary IDs †† IFNG-8901
Study Sponsor  Amgen
Collaborators ††
Investigators 
Information Provided By NIH AIDS Clinical Trials Information Service
Verification Date November 1999
First Received Date  November 2, 1999
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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