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Sponsored by: |
Sandoz Inc. |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002008 |
To determine the safety, immunogenicity, biological activity, ad pharmacokinetics of sargramostim ( recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF ) human granulocyte-macrophage colony-stimulating factor ( GM-CSF ), given by subcutaneous ( SC ) injection to patients with leukopenia in association with HIV infection.
Condition | Intervention | Phase |
---|---|---|
HIV Infections Cytopenias |
Drug: Sargramostim |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Pharmacokinetics Study |
Official Title: | An Open Label Phase I Study of Subcutaneously Administered Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia |
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Patients with the following are excluded:
Prior Medication:
Excluded within 3 weeks of study entry:
Prior Treatment:
Excluded within 4 weeks of study entry:
Risk Behavior:
Excluded within 3 months of study entry:
United States, California | |
UCLA CARE Ctr | |
Los Angeles, California, United States, 90095 | |
United States, Massachusetts | |
Beth Israel Deaconess - West Campus | |
Boston, Massachusetts, United States, 02215 |
Study ID Numbers: | 067D, 106 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002008 |
Health Authority: | United States: Food and Drug Administration |
Leukopenia Drug Evaluation Granulocyte-Macrophage Colony-Stimulating Factor |
Virus Diseases Sexually Transmitted Diseases, Viral Hematologic Diseases HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Leukocyte Disorders Leukopenia Retroviridae Infections Immunologic Deficiency Syndromes |
Communicable Diseases RNA Virus Infections Slow Virus Diseases |
Immune System Diseases Lentivirus Infections Infection |