Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia
- Registration Number
- NCT00855309
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I acyclovir sodium Patients receive weight-based IV acyclovir sodium every 8 or 12 hours. Arm II acyclovir sodium Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
- Primary Outcome Measures
Name Time Method Number of Participants Experiencing Incidence of Nephrotoxicity, Defined as a Serum Creatinine ≥ 2 Times the Patient's Baseline 24 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States