Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Comprehensive Cancer Center of Wake Forest University; Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Acyclovir

Criteria

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