Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia - Full Text View

Sponsors and Collaborators:	Wake Forest University National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00855309

Purpose

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.

Condition	Intervention	Phase
Cancer-Related Problem/Condition	Drug: acyclovir sodium	Phase III

MedlinePlus related topics: Cancer Herpes Simplex

Drug Information available for: Acyclovir Acyclovir sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Active Control
Official Title:	Low Dose Versus Weight-Based Intravenous Acyclovir for Herpes Simplex Virus Prophylaxis in the Neutropenic Patient

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Incidence of nephrotoxicity, defined as a serum creatinine ≥ 2 times the patient's baseline [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Incidence of clinical herpes simplex viral infection, defined as culture (+) from a lesion and a clinical picture of infection [ Designated as safety issue: No ]
Incidence of adverse events other than nephrotoxicity [ Designated as safety issue: Yes ]
Time to nephrotoxicity [ Designated as safety issue: No ]
Median peak serum creatinine [ Designated as safety issue: No ]
Incidence of a 25% decrease in creatinine clearance [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	November 2008
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.	Drug: acyclovir sodium Given IV
Arm II: Experimental Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.	Drug: acyclovir sodium Given IV

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Receiving treatment in inpatient oncology services at Wake Forest University Baptist Medical Center
- Receiving chemotherapy or have received chemotherapy within the past 2 weeks
- No 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
Seropositive herpes simplex virus (HSV)-1 or HSV-2 immunoglobulin antibody assay
No active HSV infection, as evidenced by any of the following:
- Positive HSV cultures
- Oral lesions
- Receiving 5 mg/kg acyclovir sodium every 8 hours
Intravenous acyclovir sodium therapy is deemed necessary by the physician based upon clinical judgement (i.e., mucositis, vomiting, decreased GI absorption),

PATIENT CHARACTERISTICS:

Creatinine clearance ≥ 50 mL/min
Negative pregnancy test
Not pregnant or nursing
No hypersensitivity to acyclovir sodium

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855309

Locations

United States, North Carolina
Wake Forest University Comprehensive Cancer Center	Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771

Sponsors and Collaborators

Wake Forest University

National Cancer Institute (NCI)

Investigators

Principal Investigator:

M. Jay Brown, PharmD

Wake Forest University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Wake Forest University Comprehensive Cancer Center ( M. Jay Brown )
Study ID Numbers:	CDR0000633817, CCCWFU-98608, IRB00007690
Study First Received:	March 3, 2009
Last Updated:	March 3, 2009
ClinicalTrials.gov Identifier:	NCT00855309 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

chemotherapeutic agent toxicity
renal toxicity
infection
neutropenia

Study placed in the following topic categories:

Virus Diseases
Body Weight
Herpes Simplex
Neutropenia
Skin Diseases, Infectious

Acyclovir
Skin Diseases
DNA Virus Infections
Antiviral Agents
Herpesviridae Infections

Additional relevant MeSH terms:

Skin Diseases, Viral
Virus Diseases
Herpes Simplex
Anti-Infective Agents
Skin Diseases, Infectious
Acyclovir

Skin Diseases
Therapeutic Uses
DNA Virus Infections
Antiviral Agents
Pharmacologic Actions
Herpesviridae Infections

ClinicalTrials.gov processed this record on May 06, 2009