Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2013-11-30

Brief Summary

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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.

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Detailed Description

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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

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Herpes Simplex

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm I

Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.

Group Type EXPERIMENTAL

acyclovir sodium

Intervention Type DRUG

Given IV

Arm II

Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.

Group Type EXPERIMENTAL

acyclovir sodium

Intervention Type DRUG

Given IV

Interventions

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acyclovir sodium

Given IV

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No