View Clinical Trial (Medical Research Study)
Low Dose Versus Weight-based Intravenous Acyclovir for Herpes Simplex Virus Prophylaxis in the Neutropenic Patient
| City: |
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Winston-Salem |
| State: |
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North Carolina |
| Zip Code: |
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27157 |
| Conditions: |
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Herpes Simplex |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| 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
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| NCT ID: |
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NCT00855309 |
| Primary Contact: |
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Principal Investigator
M. Jay Brown, PharmD
Comprehensive Cancer Center of Wake Forest University
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| Backup Contact: |
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N/A |
| Location Contact: |
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Winston-Salem, North Carolina 27157
United States
Clinical Trials Office - Wake Forest University Comprehensive
Phone: 336-713-6771
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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