A Phase I/II Study of Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia
Sargramostim
Blood-Borne Infections+16
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.From 18 to 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Beth Israel Deaconess - West Campus
Boston, United States