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| Sponsor: | Sandoz Inc. |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002263 |
Purpose
To assess the safety and efficacy of subcutaneous sargramostim ( granulocyte-macrophage colony-stimulating factor; GM-CSF ) in increasing and maintaining the granulocyte count in HIV-infected children who have developed granulocytopenia as a result of continuous intravenous ( CIV ) zidovudine ( AZT ). To assess the short-term and long-term effects of concomitant GM-CSF on other hematologic parameters. To assess the potential therapeutic benefit of concomitant GM-CSF and AZT on the natural history of HIV infection and associated infectious complications.
| Condition | Intervention |
|---|---|
|
HIV Infections Cytopenias |
Drug: Zidovudine Drug: Sargramostim |
| Study Type: | Interventional |
| Study Design: | Treatment, Dose Comparison |
| Official Title: | A Pilot Study to Evaluate the Effects of Subcutaneously Administered Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor in Pediatric HIV-Infected Patients With Neutropenia Secondary to Azidothymidine |
Eligibility| Ages Eligible for Study: | 6 Months to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Prior Medication:
Allowed within 48 hours of study entry:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Patients with the following are excluded:
Prior Medication:
Excluded within 48 hours of study entry:
Prior Treatment:
Excluded within 6 months of study entry:
Contacts and Locations
More Information
| Study ID Numbers: | 067B, 206 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002263 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Pilot Projects Neutropenia Granulocyte-Macrophage Colony-Stimulating Factor Acquired Immunodeficiency Syndrome Zidovudine |
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Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Zidovudine Leukocyte Disorders Infection Molgramostim Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors |
RNA Virus Infections Anti-HIV Agents Immune System Diseases Hematologic Diseases Acquired Immunodeficiency Syndrome Agranulocytosis Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases Neutropenia HIV Infections Sexually Transmitted Diseases Lentivirus Infections |