Trial Outcomes & Findings for Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia (NCT NCT00855309)

Last Updated: 2018-07-06

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

112 participants

Primary outcome timeframe

24 hours

Results posted on

2018-07-06

Participant milestones
Measure	Weight-based IV Acyclovir Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.	Low-dose IV Acyclovir Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
Overall Study STARTED	57	55
Overall Study COMPLETED	56	55
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal
Measure	Weight-based IV Acyclovir Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.	Low-dose IV Acyclovir Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
Overall Study patient never recieved drug	1	0

Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia

Baseline characteristics by cohort
Measure	Arm I n=57 Participants Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.	Arm II n=55 Participants Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.	Total n=112 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=5 Participants	39 Participants n=7 Participants	81 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Age, Continuous	55.3 years STANDARD_DEVIATION 13.5 • n=5 Participants	53.3 years STANDARD_DEVIATION 14.4 • n=7 Participants	54.4 years STANDARD_DEVIATION 14.0 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	27 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	28 Participants n=7 Participants	61 Participants n=5 Participants
Region of Enrollment United States	57 participants n=5 Participants	55 participants n=7 Participants	112 participants n=5 Participants

Timeframe: 24 hours

Outcome measures
Measure	Arm I n=56 Participants Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.	Arm II n=55 Participants Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
Number of Participants Experiencing Incidence of Nephrotoxicity, Defined as a Serum Creatinine ≥ 2 Times the Patient's Baseline	2 participants	3 participants

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Arm I n=56 participants at risk Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.	Arm II n=55 participants at risk Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
Renal and urinary disorders Nephrotoxicity	3.6% 2/56 • Number of events 2	5.5% 3/55 • Number of events 3

Comprehensive Cancer Center of Wake Forest University

Phone: 336-713-3416