Expired Study
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Bethesda, Maryland 20892


Purpose:

To assess the safety and efficacy of subcutaneously administered sargramostim ( granulocyte-macrophage colony-stimulating factor; GM-CSF ) in increasing and maintaining the neutrophil count in HIV-infected adults who have developed neutropenia as a result of receiving the antiretroviral agent, zidovudine ( AZT ). To assess the safety and efficacy of subcutaneously administered GM-CSF in increasing and maintaining the neutrophil count in HIV-infected adults with pre-existing neutropenia who are at high risk of developing hematologic intolerance while receiving the antiretroviral agent, AZT, for the first time. To assess the potential therapeutic benefit of concomitant GM-CSF and AZT on the natural history of HIV infection and associated infectious complications.


Criteria:

Inclusion Criteria Concurrent Treatment: Allowed: - Minimal local irradiation for tumors. Patients must have: - Diagnosis of AIDS or AIDS related complex (ARC). - Neutropenia, due either to zidovudine (AZT) or HIV infection. - Life expectancy = or > 6 months. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Significant malabsorption as defined by greater than 10 percent weight loss and one or more of the following: - Serum carotene less than 75 IU/ml. - Vitamin A level less than 75 IU/ml. - More than 4 foul-smelling or greasy stools per day. - Other criteria of malabsorption. - Kaposi's sarcoma (KS) or other tumor which is likely to require specific antitumor therapy during study, other than minimal local irradiation. - Active, life-threatening infection with bacterial, viral, fungal, or protozoan pathogens or fever of 39 degrees C within 10 days of study entry, unless it is apparent that the fever is not due to a severe underlying infection. Concurrent Medication: Excluded within 4 weeks of study entry: - Any investigational drug. - Immunomodulating agents. - Hormonal therapy. - Cytolytic chemotherapeutic agents. - Antiretroviral agent other than zidovudine (AZT). - Excluded within 4 months of study entry: - Suramin. - Excluded within 3 months of study entry: - Ribavirin. Patients with the following are excluded: - Significant malabsorption. - Tumor likely to require specific antitumor therapy during study. - Other significant medical problems and conditions specified in Patient Exclusion Co-Existing Conditions. - Uncorrected nutritional deficiencies that may contribute to neutropenia. - Hypersensitivity to zidovudine (AZT) or other nucleoside analogs. - Profound dementia or altered mental status that would prohibit the giving of informed consent. Prior Treatment: Excluded within 1 month of study entry: - Transfusion. - Excluded within 4 weeks of study entry: - Radiation therapy to greater than 100 cm2 body area. Current drug or alcohol abuse. Unprotected sexual behavior or other activities which might introduce a new inoculation of HIV during the study. Patients must be willing to refrain from unprotected sexual or other activities which might introduce a new inoculum of HIV during the study.


NCT ID:

NCT00002006


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 22, 2017

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