Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia

July 3, 2018 updated by: Wake Forest University Health Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157-1096
        • Wake Forest University Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I
Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
Drug: acyclovir sodium
Given IV
Experimental: Arm II
Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
Drug: acyclovir sodium
Given IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Experiencing Incidence of Nephrotoxicity, Defined as a Serum Creatinine ≥ 2 Times the Patient's Baseline
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: M. Jay Brown, PharmD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

March 3, 2009

First Submitted That Met QC Criteria

March 3, 2009

First Posted (Estimate)

March 4, 2009

Study Record Updates

Last Update Posted (Actual)

July 6, 2018

Last Update Submitted That Met QC Criteria

July 3, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00007690
  • P30CA012197 (U.S. NIH Grant/Contract)
  • CCCWFU-98608

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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