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Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia

Information source: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Herpes Simplex

Intervention: acyclovir sodium (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Comprehensive Cancer Center of Wake Forest University

Official(s) and/or principal investigator(s):
M. Jay Brown, PharmD, Principal Investigator, Affiliation: Comprehensive Cancer Center of Wake Forest University


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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: Number of Participants Experiencing Incidence of Nephrotoxicity, Defined as a Serum Creatinine ≥ 2 Times the Patient's Baseline

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Be 18 years of age or older.

- Receiving treatment in inpatient oncology services at Wake Forest University Baptist

Medical Center

- Receiving chemotherapy or have received chemotherapy within the past 2 weeks

- Seropositive herpes simplex virus (HSV)-1 or HSV-2 immunoglobulin antibody assay

- Creatinine clearance ≥ 50 mL/min

- Intravenous acyclovir sodium therapy is deemed necessary by the physician based upon

clinical judgement (i. e., mucositis, vomiting, decreased GI absorption) Exclusion Criteria:

- Pregnant or nursing

- Hypersensitivity to acyclovir sodium

- High tumor burden (i. e., WBC > 50,000/mm^3 at admission)

- Neutropenic, defined as one of the following:

- ANC < 500/mm^3

- ANC < 1,000/mm^3 with a predicted decrease to 500/mm^3

- Active HSV infection, as evidenced by any of the following:

- Positive HSV cultures

- Oral lesions

- Receiving 5 mg/kg acyclovir sodium every 8 hours

Locations and Contacts

Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina 27157-1096, United States
Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: November 2008
Last updated: September 8, 2014

Page last updated: August 23, 2015

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