Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Wake Forest University Comprehensive Cancer Center

M. Jay Brown, PharmD

Principal Investigator

U.S.A.
North Carolina
	Winston-Salem
	Wake Forest University Comprehensive Cancer Center
		Clinical Trials Office - Wake Forest University Comprehensive	Ph: 336-713-6771

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00855309
Information obtained from ClinicalTrials.gov on December 14, 2011

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