Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia

Herpes Simplex Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00855309
• Other study ID #: IRB00007690
• Secondary ID: P30CA012197CCCWF
• Status: Completed
• Phase: Phase 3
• Start date: November 2008
• Est. completion date: November 2013

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Herpes Simplex
• Neutropenia

Intervention

Drug:
• acyclovir sodium
Given IV

Locations

Country	Name	City	State
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing Incidence of Nephrotoxicity, Defined as a Serum Creatinine = 2 Times the Patient's Baseline		24 hours