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Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia

Primary Purpose

Herpes Simplex

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
acyclovir sodium
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Herpes Simplex focused on measuring chemotherapeutic agent toxicity, renal toxicity, infection, neutropenia

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest University Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I

Arm II

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 3, 2009
Last Updated
July 3, 2018
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00855309
Brief Title
Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia
Official Title
Low Dose Versus Weight-based Intravenous Acyclovir for Herpes Simplex Virus Prophylaxis in the Neutropenic Patient
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Simplex
Keywords
chemotherapeutic agent toxicity, renal toxicity, infection, neutropenia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
Intervention Type
Drug
Intervention Name(s)
acyclovir sodium
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Number of Participants Experiencing Incidence of Nephrotoxicity, Defined as a Serum Creatinine ≥ 2 Times the Patient's Baseline
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M. Jay Brown, PharmD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1096
Country
United States

12. IPD Sharing Statement

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