Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chemotherapeutic Agent Toxicity; Infection; Neutropenia; Renal Toxicity
Intervention: acyclovir sodium (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Wake Forest University Official(s) and/or principal investigator(s):
M. Jay Brown, PharmD, Principal Investigator, Affiliation: Wake Forest University
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.
Clinical Details
Official title: Low Dose Versus Weight-Based Intravenous Acyclovir for Herpes Simplex Virus Prophylaxis in the Neutropenic Patient
Study design: Supportive Care, Randomized, Open Label, Active Control
Primary outcome: Incidence of nephrotoxicity, defined as a serum creatinine ≥ 2 times the patient's baseline
Secondary outcome: Incidence of clinical herpes simplex viral infection, defined as culture (+) from a lesion and a clinical picture of infectionIncidence of adverse events other than nephrotoxicity Time to nephrotoxicity Median peak serum creatinine Incidence of a 25% decrease in creatinine clearance
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS:
- Receiving treatment in inpatient oncology services at Wake Forest University Baptist
Medical Center
- Receiving chemotherapy or have received chemotherapy within the past 2 weeks
- No 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
- Seropositive herpes simplex virus (HSV)-1 or HSV-2 immunoglobulin antibody assay
- No active HSV infection, as evidenced by any of the following:
- Positive HSV cultures
- Oral lesions
- Receiving 5 mg/kg acyclovir sodium every 8 hours
- Intravenous acyclovir sodium therapy is deemed necessary by the physician based upon
clinical judgement (i. e., mucositis, vomiting, decreased GI absorption),
PATIENT CHARACTERISTICS:
- Creatinine clearance ≥ 50 mL/min
- Negative pregnancy test
- Not pregnant or nursing
- No hypersensitivity to acyclovir sodium
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Locations and Contacts
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina 27157-1096, United States; Recruiting
Clinical Trials Office - Wake Forest University Comprehensive, Phone: 336-713-6771
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: November 2008
Last updated: May 9, 2009
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