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

Phase 3
18 Years
Open (Enrolling)
Herpes Simplex

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Trial Information

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


- 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.

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

Type of Study:


Study Design:

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

Outcome Measure:

Incidence of nephrotoxicity, defined as a serum creatinine ≥ 2 times the patient's baseline

Safety Issue:


Principal Investigator

M. Jay Brown, PharmD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University


United States: Institutional Review Board

Study ID:




Start Date:

November 2008

Completion Date:

Related Keywords:

  • Herpes Simplex
  • chemotherapeutic agent toxicity
  • renal toxicity
  • infection
  • neutropenia
  • Herpes Simplex
  • Neutropenia



Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096