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

Completed · Not applicable

Conditions studied: HIV Infections, Cytopenias

In brief

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.

Key facts

Study ID

NCT00002263

Run by

Sandoz

Last updated by the study team

2005-06-24

Who can join

Age: 1 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• Allowed:
• Zidovudine (AZT) on NIAID 86-C-175.
• Patients must have:
• Diagnosis of perinatal or transfusion acquired AIDS or AIDS related complex.
• Granulocytopenia (< or = to 800 cells/mm3) associated with the administration of AZT on protocol NIAID 86-C-175.
• Life expectancy > 3 months.
• Functioning indwelling central venous access device in place.
• Prior Medication:
• Allowed within 48 hours of study entry:
• Prophylactic antibiotics.

You may not qualify if…

• Co-existing Condition:
• Patients with the following conditions or symptoms are excluded:
• Critically ill or clinically unstable.
• Significant, active opportunistic or other infection requiring specific drug therapy at time of study entry.
• Ongoing IV alimentation.
• Uncorrected nutritional deficiencies that may contribute to anemia and/or leukopenia.
• Past history of or current evidence for any chronic hematologic disorder other than hemophilia A or B, anemia of chronic disease or anemia related to HIV infection.
• Malignancy likely to require systemic treatment during study.
• Patients with the following are excluded:
• Critically ill, clinically unstable, or with concomitant diseases listed in Patient Exclusion Co-existing Conditions.
• Hypersensitivity to zidovudine (AZT) or any other nucleoside analog.
• Prior Medication:
• Excluded within 48 hours of study entry:
• Antibiotics.
• Excluded within 30 days of study entry:
• Antiretroviral agents other than zidovudine (AZT).
• Acyclovir.
• Ganciclovir.
• Any investigational drug.
• Immunomodulating drugs.
• Cytolytic chemotherapeutic agents.
• Corticosteroids.
• Immunoglobulin preparations.
• Excluded within 4 months of study entry:
• Suramin.

Where it is running

• Natl Cancer Institute / HIV / AIDS Malignancy Branch — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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