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

Use our guide to learn which trials are right for you!

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.

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.

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
(336) 716-2011
Wake Forest University Comprehensive Cancer Center Our newly expanded Comprehensive Cancer Center is the region’s...
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials