Trial Outcomes & Findings for Effect of HSV-2 Suppressive Therapy on Sexual Behavior (NCT NCT00495716)
NCT ID: NCT00495716
Last Updated: 2023-03-07
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
72 participants
Primary outcome timeframe
1 year
Results posted on
2023-03-07
Participant Flow
Participant milestones
| Measure |
Episodic Treatment Arm
800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence
acyclovir: 800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence
|
Suppressive Therapy Arm
400 mg acyclovir orally twice daily for 1 year
acyclovir: 400 mg acyclovir orally twice daily for 1 year
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
37
|
|
Overall Study
COMPLETED
|
20
|
24
|
|
Overall Study
NOT COMPLETED
|
15
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of HSV-2 Suppressive Therapy on Sexual Behavior
Baseline characteristics by cohort
| Measure |
Episodic Treatment Arm
n=35 Participants
800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence
acyclovir: 800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence
|
Suppressive Therapy Arm
n=37 Participants
400 mg acyclovir orally twice daily for 1 year
acyclovir: 400 mg acyclovir orally twice daily for 1 year
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40 years
n=5 Participants
|
39 years
n=7 Participants
|
39 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 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
|
1 Participants
n=5 Participants
|
0 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
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
46 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: 1 yearPopulation: Study terminated; investigator relocated and study funding ended. Results cannot be analyzed because data were not collected.
Outcome measures
Outcome data not reported
Adverse Events
Episodic Treatment Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Suppressive Therapy Arm
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
Clinic Director
University of Washington Virology Research Clinic
Phone: 206-520-4340
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place