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Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia

This study is currently recruiting participants.
Verified January 2013 by Comprehensive Cancer Center of Wake Forest University
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00855309
First received: March 3, 2009
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Herpes Simplex
 Drug: acyclovir sodium
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Low Dose Versus Weight-based Intravenous Acyclovir for Herpes Simplex Virus Prophylaxis in the Neutropenic Patient

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Incidence of nephrotoxicity, defined as a serum creatinine ≥ 2 times the patient's baseline [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of clinical herpes simplex viral infection, defined as culture (+) from a lesion and a clinical picture of infection [ Designated as safety issue: No ]
  • Incidence of adverse events other than nephrotoxicity [ Designated as safety issue: Yes ]
  • Time to nephrotoxicity [ Designated as safety issue: No ]
  • Median peak serum creatinine [ Designated as safety issue: No ]
  • Incidence of a 25% decrease in creatinine clearance [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: November 2008
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855309

Locations
United States, North Carolina
Wake Forest University Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Clinical Trials Office - Wake Forest University Comprehensive     336-713-6771        
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Investigators
Principal Investigator: M. Jay Brown, PharmD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT00855309     History of Changes
Other Study ID Numbers: CDR0000633817, P30CA012197, CCCWFU-98608, IRB00007690
Study First Received: March 3, 2009
Last Updated: January 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
chemotherapeutic agent toxicity
renal toxicity
infection
neutropenia

Additional relevant MeSH terms:
Herpes Simplex
Neutropenia
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Agranulocytosis
 Leukopenia
Leukocyte Disorders
Hematologic Diseases
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013