Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sandoz
Treatments:
Sargramostim
Criteria
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.