NCT00002126

A Randomized, Controlled, Multicenter Trial of Filgrastim (Recombinant-Methionyl Human Granulocyte Colony Stimulating Factor; G-CSF) for the Prevention of Grade 4 Neutropenia in Patients With HIV Infection.

A Randomized, Controlled, Multicenter Trial of Filgrastim (Recombinant-Methionyl Human Granulocyte Colony Stimulating Factor; G-CSF) for the Prevention of Grade 4 Neutropenia in Patients With HIV Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 250 (planned)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

Summary

To determine, in HIV-infected patients, the efficacy of filgrastim ( recombinant-methionyl human granulocyte-colony stimulating factor; G-CSF ) in preventing grade 4 neutropenia, i.e., absolute neutrophil count (ANC) \< 500 cells/mm3.

Detailed description

Patients are randomized to receive subcutaneous G-CSF at one of two different doses or no G-CSF (observation) for 24 weeks. Patients who experience ANC \< 500 cells/mm3 on two consecutive occasions at least 24 hours apart prior to completing the 24-week study period will be considered to have reached the primary study endpoint; those in the observation group who reach the primary endpoint prior to week 24 may begin receiving G-CSF for the remainder of the study period. After 24 weeks, patients may continue G-CSF on a compassionate basis at the investigator's discretion.

Conditions

• HIV Infections
• Cytopenias

Interventions

Type	Name	Description
DRUG	Filgrastim

Timeline

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

Locations

22 sites across 2 countries: United States, Canada