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

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002009 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Phase I/II Study of Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia
Official Title ^ICMJE	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 ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Dose Comparison, Pharmacokinetics Study
Condition ^ICMJE	HIV Infections Cytopenias
Intervention ^ICMJE	Drug: Sargramostim
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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 ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002009
Responsible Party
Study ID Numbers ^ICMJE	067E, 101
Study Sponsor ^ICMJE	Sandoz Inc.
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	June 1988
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP