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

Sponsor

Sandoz (Industry)

Overall Status

Completed

CT.gov ID

NCT00002008

Collaborator

(none)

Locations

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Cytopenias	Drug: Sargramostim	Phase 1

Study Design

Study Type:

Interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.