Trial Outcomes & Findings for Randomized Trial to Evaluate Suppressive Effect of High-Dose Acyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2 (NCT NCT00362297)

Last Updated: 2021-11-18

Results Overview

Participants were treated with both interventions in a cross-over study design. Shedding rates on each drug arm per participant were compared by Poisson regression. Shedding rates were calculated by dividing the number of positive swabs by the total number of swabs for each intervention group.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

31 participants

Primary outcome timeframe

15 weeks

Results posted on

2021-11-18

Participant Flow

Dates of recruitment: November 2006-August 2008 Site: University of Washington Virology Research Clinic, Seattle, WA

Participant milestones

Participant milestones
Measure	Standard Dose First, Then High Dose	High Dose First, Then Standard Dose
Treatment 1 (Initial Drug Assignment) STARTED	16	15
Treatment 1 (Initial Drug Assignment) COMPLETED	16	11
Treatment 1 (Initial Drug Assignment) NOT COMPLETED	0	4
Treatment 2 STARTED	16	11
Treatment 2 COMPLETED	16	11
Treatment 2 NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard Dose First, Then High Dose	High Dose First, Then Standard Dose
Treatment 1 (Initial Drug Assignment) Lost to Follow-up	0	4

Baseline Characteristics

Randomized Trial to Evaluate Suppressive Effect of High-Dose Acyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Dose n=16 Participants	High-dose n=15 Participants	Total n=31 Participants Total of all reporting groups
Age, Continuous	41.6 years STANDARD_DEVIATION 13.2 • n=5 Participants	39.1 years STANDARD_DEVIATION 12.2 • n=7 Participants	40.5 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 15 weeks

Population: Participants who did not collect at least one swab on each arm of the cross-over were excluded from analysis.

Outcome measures

Outcome measures
Measure	Standard Dose Valacyclovir n=4663 Swabs	High Dose Acyclovir n=4709 Swabs
Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Acyclovir as Compared to Once-daily Valacyclovir.	4 percentage of swabs with HSV detected	4 percentage of swabs with HSV detected

Adverse Events

Standard Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

High-dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Christine Johnston

University of Washington

Phone: 206-520-4340

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place