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

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

This study has been completed.

Study NCT00002009. Last updated on June 23, 2005. Information provided by NIH AIDS Clinical Trials Information Service

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	A Phase I/II Study of Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia
Official Title ^†	A Phase I/II Study of Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia
Brief 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.
Detailed Description
Study Phase	Phase I
Study Type ^†	Interventional
Study Design ^†	Treatment, Dose Comparison, Pharmacokinetics Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	HIV Infections Cytopenias
Intervention ^†	Drug: Sargramostim
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†
Start Date ^†
Completion Date
Eligibility 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.
Gender	Male
Ages	18 Years to 50 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00002009
Organization ID	067E
Secondary IDs ^††	101
Study Sponsor ^†	Sandoz Inc.
Collaborators ^††
Investigators ^†
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	June 1988
First Received Date ^†	November 2, 1999
Last Updated Date	June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.