NCT00002433

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

November 1, 1999

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Pulmonary AlveoliMacrophage ActivationInterferon-gamma, RecombinantInjections, SubcutaneousAerosolsAcquired Immunodeficiency Syndrome

Interventions

Interferon gamma-1bDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • Prior Medication:
  • Excluded within 4 weeks of study entry:
  • Immunosuppressive therapy.
  • Cytotoxic therapy.
  • Excluded:
  • Interferon gamma therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Hosp - Cornell Med Ctr

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

interferon gamma-1b

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1999-11

Locations

US(1)