An Open Label Phase I Study of Subcutaneously Administered Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia

HIV Infections Clinical Trial

Official title:

An Open Label Phase I Study of Subcutaneously Administered Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002008
• Other study ID #: 067D
• Secondary ID: 106
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: January 1989
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To determine the safety, immunogenicity, biological activity, ad pharmacokinetics of sargramostim ( recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF ) human granulocyte-macrophage colony-stimulating factor ( GM-CSF ), given by subcutaneous ( SC ) injection to patients with leukopenia in association with HIV infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria

Patients must have:

• Serum antibody to HIV with or without evidence of HIV.

• Antigenemia.

• Anticipated survival of at least 6 months.

• Allowed:

• Kaposi's sarcoma.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

• Malignancy other than Kaposi's sarcoma.

• Excessive diarrhea (more than 5 liquid or non-liquid stools per day).

• Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infection.

• Primary hematologic or infectious disorders unrelated to AIDS virus infection.

• Dementia or altered mental status that would prohibit the giving and understanding of informed consent.

Patients with the following are excluded:

• History of malignancy other than Kaposi's sarcoma.

• Currently hospitalized or hospitalized within 4 weeks for the treatment of opportunistic infection.

Prior Medication:

Excluded within 3 weeks of study entry:

• Marrow suppressive medication.

• Excluded within 4 weeks of study entry:

• Any investigational drug.

Prior Treatment:

Excluded within 4 weeks of study entry:

• Systemic cytotoxic chemotherapy.

• Irradiation.

Risk Behavior:

Excluded within 3 months of study entry:

• Regular, excessive users of alcohol, hallucinogens, or agents which are addicting.

Study Design

Endpoint Classification: Pharmacokinetics Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cytopenias
• HIV Infections
• Infection
• Leukopenia
• Virus Diseases

Intervention

Drug:
• Sargramostim

Locations

Country	Name	City	State
United States	Beth Israel Deaconess - West Campus	Boston	Massachusetts
United States	UCLA CARE Ctr	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz Inc.

Country where clinical trial is conducted

United States,