Completed

Aerosolized r-metHuIFN-Gamma for Activation of Alveolar Macrophages in AIDS Patients

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Study Aim

This study aims to treat AIDS patients by activating alveolar macrophages using Aerosolized r-metHuIFN-Gamma.

What is being tested

Interferon gamma-1b

Drug
Who is being recruted

Blood-Borne Infections+13

+ Urogenital Diseases

+ Genital Diseases

From 18 to 65 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorAmgen
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study focuses on patients with AIDS, a condition that weakens the immune system. The main goal is to explore the safety and effectiveness of a specific treatment called aerosolized recombinant interferon gamma (IFN-gamma). This treatment is a man-made version of a protein that our bodies naturally produce to fight infections. The researchers aim to activate a type of white blood cell called alveolar macrophages, which play a crucial role in defending the lungs against infections. The study also investigates whether this treatment could potentially improve the care for AIDS patients by strengthening their immune response.

NCT00002433
Principal SponsorAmgen
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

12 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeHIV Infections

Criteria

4 inclusion criteria required to participate
Diagnosis of AIDS with one or more opportunistic infections
Kaposi's sarcoma with prior history of opportunistic infection
Preserved pulmonary, renal and hepatic function
Stable dose of zidovudine (AZT) therapy
10 exclusion criteria prevent from participating
Active opportunistic infections
Cardiac disease
Central nervous system disorders
Co-existing conditions and symptoms listed in Patient Exclusion Co-existing Conditions
Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

New York Hosp - Cornell Med Ctr

New York, United StatesOpen New York Hosp - Cornell Med Ctr in Google Maps
CompletedOne Study Center