Trial Outcomes & Findings for Randomized Trial to Evaluate Suppressive Effect of High-Dose Valacyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2 (NCT NCT01346475)
NCT ID: NCT01346475
Last Updated: 2017-03-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
11 weeks
Results posted on
2017-03-09
Participant Flow
Participants recruited from October 2008 to April 2010. Participants recruited at the University of Washington Virology Research Clinic in Seattle, WA.
Participant milestones
| Measure |
Standard-dose Valacyclovir First Then High-dose Valacyclovir
Standard-dose valacyclovir (500 mg daily) for 5 weeks followed by 1 week wash-out and then high-dose valacyclovir (1 gram three times daily) for 5 weeks
|
High-dose Valacyclovir First Then Standard-dose Valacyclovir
High-dose valacyclovir (1 gram three times daily) for 5 weeks followed by 1 week wash-out and then standard-dose valacyclovir (500 mg daily) for 5 weeks
|
|---|---|---|
|
First Intervention
STARTED
|
22
|
28
|
|
First Intervention
COMPLETED
|
18
|
25
|
|
First Intervention
NOT COMPLETED
|
4
|
3
|
|
Second Intervention
STARTED
|
18
|
25
|
|
Second Intervention
COMPLETED
|
18
|
25
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Standard-dose Valacyclovir First Then High-dose Valacyclovir
Standard-dose valacyclovir (500 mg daily) for 5 weeks followed by 1 week wash-out and then high-dose valacyclovir (1 gram three times daily) for 5 weeks
|
High-dose Valacyclovir First Then Standard-dose Valacyclovir
High-dose valacyclovir (1 gram three times daily) for 5 weeks followed by 1 week wash-out and then standard-dose valacyclovir (500 mg daily) for 5 weeks
|
|---|---|---|
|
First Intervention
Lost to Follow-up
|
4
|
3
|
Baseline Characteristics
Randomized Trial to Evaluate Suppressive Effect of High-Dose Valacyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2
Baseline characteristics by cohort
| Measure |
Valacyclovir
n=22 Participants
|
High Dose Valacyclovir
n=28 Participants
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.9 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
37.7 years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
40.4 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 11 weeksPopulation: Participants who collected at least one swab on each arm of the cross-over were included in the analysis.
Outcome measures
| Measure |
Standard-dose Valacyclovir (500 mg Daily)
n=5008 Swabs
|
High-dose Valacyclovir (1 gm Three Times Daily)
n=4973 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 Valacyclovir as Compared to Once-daily Valacyclovir.
|
5 percentage of swabs with HSV detected
|
3 percentage of swabs with HSV detected
|
SECONDARY outcome
Timeframe: 11 weeksMedian quantity of HSV detected, among swabs with any HSV detected
Outcome measures
| Measure |
Standard-dose Valacyclovir (500 mg Daily)
n=292 swabs
|
High-dose Valacyclovir (1 gm Three Times Daily)
n=164 swabs
|
|---|---|---|
|
Quantity of HSV Detected, Median
|
3.0 log 10 copies/ml
Interval 2.4 to 4.5
|
2.5 log 10 copies/ml
Interval 2.3 to 2.7
|
SECONDARY outcome
Timeframe: 11 weeksThe number of HSV shedding episodes. A shedding episode is defined as any number of positive swabs preceded and followed by 2 negative swabs.
Outcome measures
| Measure |
Standard-dose Valacyclovir (500 mg Daily)
n=43 Participants
|
High-dose Valacyclovir (1 gm Three Times Daily)
n=43 Participants
|
|---|---|---|
|
Number of Genital HSV Shedding Episodes
|
58 Episodes
|
65 Episodes
|
SECONDARY outcome
Timeframe: 11 weeksMedian duration of HSV shedding episodes, in hours, among episodes of known duration
Outcome measures
| Measure |
Standard-dose Valacyclovir (500 mg Daily)
n=42 Episodes
|
High-dose Valacyclovir (1 gm Three Times Daily)
n=41 Episodes
|
|---|---|---|
|
Duration of Genital HSV Shedding Episodes
|
10 Hours
Interval 7.0 to 42.0
|
7 Hours
Interval 6.0 to 9.0
|
Adverse Events
Valacyclovir
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
High Dose Valacyclovir
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Valacyclovir
n=44 participants at risk
|
High Dose Valacyclovir
n=44 participants at risk
|
|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/44 • Adverse event data was collected for the 11 week study period.
Adverse event data was collected on 43 participants who completed the trial. In addition, 1 participant who withdrew during the standard dose valacyclovir arm and 1 participant who withdrew during the high dose valacyclovir arm had adverse events, and these data are included in the total number of AEs and participants included.
|
29.5%
13/44 • Adverse event data was collected for the 11 week study period.
Adverse event data was collected on 43 participants who completed the trial. In addition, 1 participant who withdrew during the standard dose valacyclovir arm and 1 participant who withdrew during the high dose valacyclovir arm had adverse events, and these data are included in the total number of AEs and participants included.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/44 • Adverse event data was collected for the 11 week study period.
Adverse event data was collected on 43 participants who completed the trial. In addition, 1 participant who withdrew during the standard dose valacyclovir arm and 1 participant who withdrew during the high dose valacyclovir arm had adverse events, and these data are included in the total number of AEs and participants included.
|
6.8%
3/44 • Adverse event data was collected for the 11 week study period.
Adverse event data was collected on 43 participants who completed the trial. In addition, 1 participant who withdrew during the standard dose valacyclovir arm and 1 participant who withdrew during the high dose valacyclovir arm had adverse events, and these data are included in the total number of AEs and participants included.
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
0.00%
0/44 • Adverse event data was collected for the 11 week study period.
Adverse event data was collected on 43 participants who completed the trial. In addition, 1 participant who withdrew during the standard dose valacyclovir arm and 1 participant who withdrew during the high dose valacyclovir arm had adverse events, and these data are included in the total number of AEs and participants included.
|
4.5%
2/44 • Number of events 2 • Adverse event data was collected for the 11 week study period.
Adverse event data was collected on 43 participants who completed the trial. In addition, 1 participant who withdrew during the standard dose valacyclovir arm and 1 participant who withdrew during the high dose valacyclovir arm had adverse events, and these data are included in the total number of AEs and participants included.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.5%
2/44 • Number of events 2 • Adverse event data was collected for the 11 week study period.
Adverse event data was collected on 43 participants who completed the trial. In addition, 1 participant who withdrew during the standard dose valacyclovir arm and 1 participant who withdrew during the high dose valacyclovir arm had adverse events, and these data are included in the total number of AEs and participants included.
|
4.5%
2/44 • Number of events 2 • Adverse event data was collected for the 11 week study period.
Adverse event data was collected on 43 participants who completed the trial. In addition, 1 participant who withdrew during the standard dose valacyclovir arm and 1 participant who withdrew during the high dose valacyclovir arm had adverse events, and these data are included in the total number of AEs and participants included.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review and comment on any proposed publication, and all Study results and data reasonably necessary for a meaningful review of the proposed publication are submitted to the sponsor for a period of at least thirty (30) days prior to submitting the publication to any third party.
- Publication restrictions are in place
Restriction type: OTHER