Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia
Status: | Completed |
---|---|
Conditions: | Infectious Disease, Hematology |
Therapuetic Areas: | Hematology, Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 120 |
Updated: | 7/8/2018 |
Start Date: | November 2008 |
End Date: | November 2013 |
Low Dose Versus Weight-based Intravenous Acyclovir for Herpes Simplex Virus Prophylaxis in the Neutropenic Patient
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.
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.
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.
- 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.
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
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Comprehensive Cancer Center Our newly expanded Comprehensive Cancer Center is the region’s...
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