Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia

Wake Forest University (WFU)

Status and phase: Completed; Phase 3

Conditions: Herpes Simplex

Treatments: Drug: acyclovir sodium

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00855309

P30CA012197 (U.S. NIH Grant/Contract)

IRB00007690

CCCWFU-98608

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

Arm I

Experimental group

Description:

Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.

Treatment:

Drug: acyclovir sodium

Arm II

Experimental group

Description:

Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.

Treatment:

Drug: acyclovir sodium