Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia

NCT00855309 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: IRB00007690P30CA012197CCCWFU-98608
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Herpes Simplex

Keywords

chemotherapeutic agent toxicity; renal toxicity; infection; neutropenia

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Incidence of Nephrotoxicity, Defined as a Serum Creatinine ≥ 2 Times the Patient's Baseline

  24 hours

Study Arms (2)

Arm I

EXPERIMENTAL

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

Drug: acyclovir sodium

Arm II

EXPERIMENTAL

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

Drug: acyclovir sodium

Interventions

acyclovir sodium DRUG

Given IV

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

MeSH Terms

Conditions

Herpes Simplex; Infections; Neutropenia

Interventions

Acyclovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

per the protocol, only nephrotoxicities (as measured by Creatinine increase over baseline were observed.

Results Point of Contact

• Title: LeAnne Kenndy, PharmD
• Organization: Comprehensive Cancer Center of Wake Forest University

lakenned@wakehealth.edu

336-713-3416

Study Officials

• M. Jay Brown, PharmD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2009
• First Posted: March 4, 2009
• Study Start: November 1, 2008
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: July 6, 2018
• Results First Posted: November 25, 2013

Record last verified: 2018-07

Locations

US (1)