Status:
COMPLETED
Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Herpes Simplex
Eligibility:
All Genders
18-120 years
Phase:
PHASE3
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...
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. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00855309
Start Date
November 1 2008
End Date
November 1 2013
Last Update
July 6 2018
Active Locations (1)
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1
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096