Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia - Full Text View

Sponsor:	Wake Forest University
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Wake Forest University
ClinicalTrials.gov Identifier:	NCT00855309

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 III

Study Type:	Interventional
Study Design:	Allocation: Randomized 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:

Genetics Home Reference related topics: cyclic neutropenia

MedlinePlus related topics: Herpes Simplex

Drug Information available for: Acyclovir Acyclovir sodium

U.S. FDA Resources

Further study details as provided by 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:	July 2012 (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

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:	M. Jay Brown, Wake Forest University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00855309 History of Changes
Other Study ID Numbers:	CDR0000633817, P30CA012197, CCCWFU-98608, IRB00007690
Study First Received:	March 3, 2009
Last Updated:	September 16, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by 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 February 09, 2012