Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia

Wake Forest University Health Sciences112 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

112

Conditions

Herpes Simplex

Interventions

acyclovir sodiumDRUG

Given IV

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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 (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

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

Time frame: 24 hours

Data from ClinicalTrials.gov

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