Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Active	Adult	NCI	CCCWFU-98608 CCCWFU98608, IRB00007690, NCT00855309

Objectives

1. 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.

Entry Criteria

Disease Characteristics:

• Receiving treatment in inpatient oncology services at Wake Forest University Baptist Medical Center
  • Receiving chemotherapy or have received chemotherapy within the past 2 weeks
  • No high tumor burden (i.e., WBC > 50,000/mm³ at admission)
• Neutropenic, defined as one of the following:
  • ANC < 500/mm³
  • ANC < 1,000/mm³ with a predicted decrease to 500/mm³
• Seropositive herpes simplex virus (HSV)-1 or HSV-2 immunoglobulin antibody assay
• No active HSV infection, as evidenced by any of the following:
  • Positive HSV cultures
  • Oral lesions
  • Receiving 5 mg/kg acyclovir sodium every 8 hours
• Intravenous acyclovir sodium therapy is deemed necessary by the physician based upon clinical judgement (i.e., mucositis, vomiting, decreased GI absorption),

Prior/Concurrent Therapy:

• See Disease Characteristics

Patient Characteristics:

• Creatinine clearance ≥ 50 mL/min
• Negative pregnancy test
• Not pregnant or nursing
• No hypersensitivity to acyclovir sodium

Expected Enrollment

Outcomes

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

Incidence of clinical herpes simplex viral infection, defined as culture (+) from a lesion and a clinical picture of infection
Incidence of adverse events other than nephrotoxicity
Time to nephrotoxicity
Median peak serum creatinine
Incidence of a 25% decrease in creatinine clearance

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.

Trial Contact Information

Trial Lead Organizations

Wake Forest University Comprehensive Cancer Center

M. Jay Brown, PharmD, Principal investigator		Ph: 336-713-3448; 800-446-2255

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

Registry Information
Official Title		Low dose versus weight-based intravenous acyclovir for herpes simplex virus prophylaxis in the neutropenic patient
Trial Start Date		2008-11-11
Trial Completion Date		2010-07-01 (estimated)
Registered in ClinicalTrials.gov		NCT00855309
Date Submitted to PDQ		2009-01-26
Information Last Verified		2009-11-02
NCI Grant/Contract Number		CA12197

Back to Top