Expired Study
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New York, New York 10021


Purpose:

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.


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.


Study is Available At:


Original ID:

062A


NCT ID:

NCT00002433


Secondary ID:

IFNG-8901


Study Acronym:


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

NIH AIDS Clinical Trials Information Service


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety Study, Primary Pu


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

12


Enrollment Type:


Study Dates

Verification Date:November 1999
Last Changed Date:June 23, 2005
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Interferon gamma-1b

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Amgen

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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