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Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia - NCT00855309-27157(Clinical Trial 275613)



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City:  Winston-Salem
State:  
NC
Zip Code: 27157
Conditions: Herpes Simplex
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.
Study summary: 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.
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
Study is available at: Wake Forest University Comprehensive Cancer Center
Winston-Salem, NC 27157
United States

Primary Contact:
Clinical Trials Office - Wake Forest University Comprehensive
Phone: 336-713-6771
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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