Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia

Last updated: July 3, 2018
Sponsor: Wake Forest University Health Sciences
Overall Status: Completed

Phase

3

Condition

Neutropenia

Treatment

N/A

Clinical Study ID

NCT00855309
IRB00007690
CCCWFU-98608
IRB00007690
P30CA012197
  • Ages 18-120
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Be 18 years of age or older.

  • Receiving treatment in inpatient oncology services at Wake Forest University BaptistMedical 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 uponclinical judgement (i.e., mucositis, vomiting, decreased GI absorption)

Exclusion

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 Design

Total Participants: 112
Study Start date:
November 01, 2008
Estimated Completion Date:
November 30, 2013

Study 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.

Connect with a study center

  • Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina 27157-1096
    United States

    Site Not Available

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