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Completed

NCT Number: NCT00855309

Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia

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.

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Key information

Conditions

Herpes Simplex Agranulocytosis Cytopenia DNA Virus Infections Hematologic Diseases Hemic and Lymphatic Diseases Herpesviridae Infections Infections Leukocyte Disorders Leukopenia Neutropenia Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Virus Diseases

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acyclovir sodium

Drug

Given IV

Primary outcomes

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

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Mar 4, 2009
Registry last updated
Jul 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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