Trial Outcomes & Findings for A Randomized Trial to Evaluated the Suppressive Effect of Acyclovir on Rapidly Cleared HSV-2 Reactivation (NCT NCT00723229)
NCT ID: NCT00723229
Last Updated: 2017-03-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
48 participants
Primary outcome timeframe
9 weeks
Results posted on
2017-03-09
Participant Flow
Participants were recruited between July 2008 and March 2010. Participants were enrolled at the University of Washington Virology Research Clinic, Seattle, WA.
Participant milestones
| Measure |
No Medication First, Then Standard-dose Acyclovir
No medication for 4 weeks, then 1 week washout, followed by acyclovir 400 mg twice daily for 4 weeks
|
Acyclovir 400 mg Twice Daily First, Followed by no Medication
Acyclovir 400 mg twice daily for 4 weeks, then 1 week washout, followed by no medication for 4 weeks
|
|---|---|---|
|
First Intervention
STARTED
|
25
|
23
|
|
First Intervention
COMPLETED
|
18
|
20
|
|
First Intervention
NOT COMPLETED
|
7
|
3
|
|
Second Intervention
STARTED
|
18
|
20
|
|
Second Intervention
COMPLETED
|
18
|
20
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
No Medication First, Then Standard-dose Acyclovir
No medication for 4 weeks, then 1 week washout, followed by acyclovir 400 mg twice daily for 4 weeks
|
Acyclovir 400 mg Twice Daily First, Followed by no Medication
Acyclovir 400 mg twice daily for 4 weeks, then 1 week washout, followed by no medication for 4 weeks
|
|---|---|---|
|
First Intervention
Lost to Follow-up
|
7
|
3
|
Baseline Characteristics
A Randomized Trial to Evaluated the Suppressive Effect of Acyclovir on Rapidly Cleared HSV-2 Reactivation
Baseline characteristics by cohort
| Measure |
No Medication
n=25 Participants
|
Acyclovir 400 mg Twice Daily
n=23 Participants
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.6 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
42.1 years
STANDARD_DEVIATION 13.1 • n=7 Participants
|
44.4 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 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
|
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
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 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
|
|
HIV serostatus
HIV seropositive
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
HIV serostatus
HIV seronegative
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 weeksPopulation: Participants collected at least one swab on each study arm
Outcome measures
| Measure |
No Medication
n=3525 Swabs
|
Acyclovir 400 mg Twice Daily
n=3496 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 Suppressive Acyclovir as Compared to no Medication in HIV Seronegative and HIV Seropositive Individuals.
HIV seronegative
|
24 percentage of swabs with HSV detected
|
3 percentage of swabs with HSV detected
|
|
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 Suppressive Acyclovir as Compared to no Medication in HIV Seronegative and HIV Seropositive Individuals.
HIV seropositive
|
15 percentage of swabs with HSV detected
|
7 percentage of swabs with HSV detected
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: The number of swabs with HSV detected was analyzed. This is a subset of overall numbers of swabs collected, since not all swabs had HSV detected.
Median quantity of HSV detected, among swabs with any HSV detected
Outcome measures
| Measure |
No Medication
n=587 Swabs
|
Acyclovir 400 mg Twice Daily
n=120 Swabs
|
|---|---|---|
|
Quantity of HSV Detected, Median
HIV seronegative
|
3.3 log 10 copies/ml
Interval 2.5 to 5.7
|
2.9 log 10 copies/ml
Interval 2.4 to 3.4
|
|
Quantity of HSV Detected, Median
HIV seropositive
|
5.4 log 10 copies/ml
Interval 2.2 to 8.9
|
3.3 log 10 copies/ml
Interval 2.6 to 6.3
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: The number of participants analyzed is the same as the overall number. No participants were excluded from this analysis.
The 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 |
No Medication
n=38 Participants
|
Acyclovir 400 mg Twice Daily
n=38 Participants
|
|---|---|---|
|
Number of Genital HSV Shedding Episodes
HIV seronegative
|
49 Episodes
|
17 Episodes
|
|
Number of Genital HSV Shedding Episodes
HIV seropositive
|
20 Episodes
|
17 Episodes
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: Only episodes of known duration were included
Median duration of HSV shedding episodes, in hours
Outcome measures
| Measure |
No Medication
n=56 Episodes
|
Acyclovir 400 mg Twice Daily
n=33 Episodes
|
|---|---|---|
|
Duration of Genital HSV Shedding Episodes
HIV seronegative
|
13 Hours
Interval 7.0 to 73.0
|
7 Hours
Interval 6.0 to 13.0
|
|
Duration of Genital HSV Shedding Episodes
HIV seropositive
|
6 Hours
Interval 5.0 to 126.0
|
8 Hours
Interval 6.0 to 426.0
|
Adverse Events
No Medication
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Acyclovir 400 mg Twice Daily
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place