An Open Label Phase I Study of Subcutaneously Administered Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia
HIV Infections, Cytopenias
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Leukopenia, Drug Evaluation, Granulocyte-Macrophage Colony-Stimulating Factor
Eligibility 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.
Sites / Locations
- UCLA CARE Ctr
- Beth Israel Deaconess - West Campus