NCT00002263

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: —
• Sponsor: Sandoz · Industry
• Sex: All
• Age: 6 Months – 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• HIV Infections
• Cytopenias

Interventions

Type	Name	Description
DRUG	Zidovudine
DRUG	Sargramostim

Timeline

• First posted: 2001-08-31
• Last updated: 2005-06-24

Locations

1 site across 1 country: United States