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

Amgen

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Interferon gamma-1b

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002433

IFNG-8901

062A

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.