NCT00855309

Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia

Low Dose Versus Weight-based Intravenous Acyclovir for Herpes Simplex Virus Prophylaxis in the Neutropenic Patient

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Acyclovir may be effective in preventing herpes simplex virus infection in patients with neutropenia. PURPOSE: This randomized phase III trial is studying the side effects of acyclovir and is comparing two doses of acyclovir in preventing herpes simplex virus infection in patients with neutropenia.

Detailed description

OBJECTIVES: * To determine the difference in nephrotoxicity between low-dose and weight-based intravenous acyclovir sodium as herpes simplex virus infection prophylaxis in patients with neutropenia. OUTLINE: Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive weight-based IV acyclovir sodium every 8 or 12 hours. * Arm II: Patients receive low-dose IV acyclovir sodium every 8 or 12 hours. Treatment continues for approximately 2 weeks unless clinical herpes simplex virus infection is confirmed or the patient is no longer neutropenic.

Conditions

• Herpes Simplex

Interventions

Type	Name	Description
DRUG	acyclovir sodium	Given IV

Timeline

• Start date: 2008-11-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2009-03-04
• Last updated: 2018-07-06
• Results posted: 2013-11-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study