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Sponsored by: |
Sandoz Inc. |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002263 |
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 |
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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 |
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:
Study ID Numbers: | 067B, 206 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002263 |
Health Authority: | United States: Food and Drug Administration |
Pilot Projects Neutropenia Granulocyte-Macrophage Colony-Stimulating Factor Acquired Immunodeficiency Syndrome Zidovudine |
Sexually Transmitted Diseases, Viral Hematologic Diseases Acquired Immunodeficiency Syndrome Agranulocytosis Zidovudine Leukocyte Disorders Molgramostim Granulocytopenia |
Immunologic Deficiency Syndromes Virus Diseases Neutropenia HIV Infections Sexually Transmitted Diseases Neoplasm Metastasis Leukopenia Retroviridae Infections |
Antimetabolites Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |