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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Interferon gamma-1b

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Pulmonary Alveoli, Macrophage Activation, Interferon-gamma, Recombinant, Injections, Subcutaneous, Aerosols, Acquired Immunodeficiency Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

New York Hosp - Cornell Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002433

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT00002433

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 1999

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Amgen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

Pulmonary Alveoli, Macrophage Activation, Interferon-gamma, Recombinant, Injections, Subcutaneous, Aerosols, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Enrollment

12 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Interferon gamma-1b

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

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.

Facility Information:

Facility Name

New York Hosp - Cornell Med Ctr

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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