Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT00855309
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 112
• Location: 1
• Arms: 2
• Duration (Months): 60
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Herpes Simplex	Drug: acyclovir sodium	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 112 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Low Dose Versus Weight-based Intravenous Acyclovir for Herpes Simplex Virus Prophylaxis in the Neutropenic Patient
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.	Drug: acyclovir sodium; Given IV
Experimental: Arm II Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.	Drug: acyclovir sodium; Given IV

Outcome Measures

Primary Outcome Measures

1. Number of Participants Experiencing Incidence of Nephrotoxicity, Defined as a Serum Creatinine ≥ 2 Times the Patient's Baseline [24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina	United States	27157-1096

Sponsors and Collaborators

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

Investigators

• Principal Investigator: M. Jay Brown, PharmD, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT00855309
• Other Study ID Numbers: IRB00007690; P30CA012197; CCCWFU-98608; IRB00007690
• First Posted: Mar 4, 2009
• Last Update Posted: Jul 6, 2018
• Last Verified: Jul 1, 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Wake Forest University Health Sciences: chemotherapeutic agent toxicity; renal toxicity; infection; neutropenia
• Additional relevant MeSH terms: Herpes Simplex; Neutropenia; Acyclovir

Study Results

Participant Flow

Arm/Group Title	Weight-based IV Acyclovir	Low-dose IV Acyclovir
Arm/Group Description	Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.	Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
Period Title: Overall Study
STARTED	57	55
COMPLETED	56	55
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Arm I	Arm II	Total
Arm/Group Description	Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.	Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.	Total of all reporting groups
Overall Participants	57	55	112
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	42 73.7%	39 70.9%	81 72.3%
>=65 years	15 26.3%	16 29.1%	31 27.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.3 (13.5)	53.3 (14.4)	54.4 (14.0)
Sex: Female, Male (Count of Participants)
Female	24 42.1%	27 49.1%	51 45.5%
Male	33 57.9%	28 50.9%	61 54.5%
Region of Enrollment (participants) [Number]
United States	57 100%	55 100%	112 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Experiencing Incidence of Nephrotoxicity, Defined as a Serum Creatinine ≥ 2 Times the Patient's Baseline
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I	Arm II
Arm/Group Description	Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.	Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
Measure Participants	56	55
Number [participants]	2 3.5%	3 5.5%

Adverse Events

Arm/Group Title	Arm I		Arm II
Arm/Group Description	Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.		Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
All Cause Mortality
	Arm I		Arm II
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm I		Arm II
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0%)		0/55 (0%)
Other (Not Including Serious) Adverse Events
	Arm I		Arm II
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/56 (3.6%)		3/55 (5.5%)
Renal and urinary disorders
Nephrotoxicity	2/56 (3.6%)	2	3/55 (5.5%)	3

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.