Overview

This trial is active, not recruiting.

Condition herpes simplex
Treatment acyclovir sodium
Phase phase 3
Sponsor Comprehensive Cancer Center of Wake Forest University
Collaborator National Cancer Institute (NCI)
Start date November 2008
End date September 2013
Trial size 112 participants
Trial identifier NCT00855309, CCCWFU-98608, CDR0000633817, IRB00007690, P30CA012197

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
acyclovir sodium
Given IV
(Experimental)
Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
acyclovir sodium
Given IV

Primary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Low Dose Versus Weight-based Intravenous Acyclovir for Herpes Simplex Virus Prophylaxis in the Neutropenic Patient
Principal investigator M. Jay Brown, PharmD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Comprehensive Cancer Center of Wake Forest University.