Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Herpes Simplex

Intervention / Treatment
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* Drug: acyclovir sodium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients receive weight-based IV acyclovir sodium every 8 or 12 hours. | Drug: acyclovir sodium<br>* Given IV<br>|
| Experimental: Arm II<br>Patients receive low-dose IV acyclovir sodium every 8 or 12 hours. | Drug: acyclovir sodium<br>* Given IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing Incidence of Nephrotoxicity, Defined as a Serum Creatinine ≥ 2 Times the Patient's Baseline |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemotherapeutic agent toxicity, renal toxicity, infection, neutropenia