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| Sponsor: | Sandoz Inc. |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002009 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Cytopenias |
Drug: Sargramostim |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Dose Comparison, Pharmacokinetics Study |
| Official Title: | A Phase I/II Study of Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia |
Eligibility| 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:
Prior Treatment:
Excluded within 6 weeks of study entry:
Risk Behavior:
Excluded within 3 months of study entry:
Contacts and Locations| 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 | |
More Information
| Study ID Numbers: | 067E, 101 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002009 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Leukopenia Drug Evaluation Granulocyte-Macrophage Colony-Stimulating Factor |
|
Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Hematologic Diseases Acquired Immunodeficiency Syndrome Leukocyte Disorders |
Infection Immunologic Deficiency Syndromes Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Leukopenia Retroviridae Infections |