Conditions: Genital Herpes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 72
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine what effect suppressive therapy has on sexual behavior and quality of life among persons with genital herpes (HSV) who have multiple sex partners.

Study terminated; investigator relocated and study funding ended. Results were never analyzed because data were not collected.

Detailed description:
We plan to conduct a randomized controlled trial of chronic suppressive acyclovir, 400 mg orally twice daily (standard dose) versus episodic acyclovir for treatment of genital herpes recurrences. We will enroll 500 HSV-2 seropositive single persons (250 per arm), stratified by gender and history of symptomatic genital herpes, and prospectively follow them for 1 year to assess sexual behavior, adherence to therapy, and herpes-related quality of life. These outcomes will be measured by self-report in a confidential, computer-based assessment. We plan to use data from this trial to model the effect that increasing the proportion of sexually-active HSV-2 infected persons taking suppressive therapy will have on population-level incidence and prevalence of HSV-2.

Arms:
arm 1: 800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence arm 2: 400 mg acyclovir orally twice daily for 1 year

Interventions: intervention 1: acyclovir intervention 2: acyclovir
Intervention descriptions: intervention 1: 800 mg acyclovir orally 3 times daily for 2 days at the start of a genital herpes recurrence intervention 2: 400 mg acyclovir orally twice daily for 1 year

Protocol document: