Clinical Trial: Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.

Sponsor: Wake Forest University Health Sciences

Current Primary Outcome: Number of Participants Experiencing Incidence of Nephrotoxicity, Defined as a Serum Creatinine ≥ 2 Times the Patient's Baseline [ Time Frame: 24 hours ]

Original Primary Outcome: Incidence of Nephrotoxicity, Defined as a Serum Creatinine ≥ 2 Times the Patient's Baseline

Current Secondary Outcome:

Original Secondary Outcome:

  • Incidence of clinical herpes simplex viral infection, defined as culture (+) from a lesion and a clinical picture of infection
  • Incidence of adverse events other than nephrotoxicity
  • Time to nephrotoxicity
  • Median peak serum creatinine
  • Incidence of a 25% decrease in creatinine clearance


Information By: Wake Forest University Health Sciences

Dates:
Date Received: March 3, 2009
Date Started: November 2008
Date Completion:
Last Updated: January 17, 2017
Last Verified: September 2014