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	Treatment or Intervention
HIV Infections	Drug: Interferon gamma-1b

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

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.

New York
      New York Hosp - Cornell Med Ctr, New York,  New York,  10021,  United States

Study ID Numbers:  062A; IFNG-8901
Record last reviewed:  November 1999
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002433
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08