A Phase I/II Study of Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia

Study Overview
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Brief Summary
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To determine the maximum tolerated dose (MTD) and toxicity of sargramostim (recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF) given by continuous intravenous infusion (CIV) in patients with leukopenia in association with AIDS virus infection. In addition, single dose and steady state pharmacokinetics will also be determined.

Official Title
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A Phase I/II Study of Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia

Conditions
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HIV Infections, Cytopenias

Intervention / Treatment
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* Drug: Sargramostim


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients must have: Met the CDC criteria for the diagnosis of AIDS. Total peripheral blood leukocyte count = or < 3000 cells/mm3 measured on at least two occasions separated by a minimum of one week. Must have or have recovered from one or more opportunistic infection. Serum antibody to HTLV-III/LAV with or without viremia. Anticipated survival of at least 6 months. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: AIDS related complex (ARC). History of malignancy other than Kaposi's sarcoma (KS). 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 infections. Presence of renal dysfunction. Other evidence of primary hematologic or infectious disorders unrelated to AIDS virus infection. Patients with the following are excluded: AIDS related complex (ARC). History of malignancy other than Kaposi's sarcoma (KS). 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 an opportunistic infection. Dementia or altered mental status that would prohibit the giving and understanding of informed consent. Prior Medication: Excluded: Any marrow suppressive medications such as trimethoprim-sulfamethoxazole combination (TMP-PurposeX) or Fansidar. Excluded within 6 weeks of study entry: Any investigational drug. Prior Treatment: Excluded within 6 weeks of study entry: Systemic cytotoxic chemotherapy or irradiation. Risk Behavior: Excluded within 3 months of study entry: Regular, excessive use of alcohol, hallucinogens or agents which are addicting.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sargramostim|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leukopenia, Drug Evaluation, Granulocyte-Macrophage Colony-Stimulating Factor