Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia

Completed · Phase 3

Conditions studied: Herpes Simplex

In brief

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.

Key facts

Study ID

NCT00855309

Run by

Wake Forest University Health Sciences

People needed

112

Starts

2008-11-01

Expected to finish

2013-11-01

Last updated by the study team

2018-07-06

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Wake Forest University Comprehensive Cancer Center — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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