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

NCT00362297 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2021-11-18

Study results available
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Summary

The purpose of the research study is to evaluate the effectiveness of high-dose acyclovir compared to valacyclovir for reduction of asymptomatic genital shedding in persons with genital herpes.

The study will enroll men and women who are 18 years or older, test positive to HSV-2 (by blood test) and have had a first outbreak of HSV-2 within the past 6 months or have had at least 4 genital herpes outbreaks in the past year. Participants must be HIV negative and willing to stop taking suppressive therapy for HSV for the one week wash out period. (Females only: You must not be pregnant or breast-feeding). Both men and women will be asked to use an effective form of birth control.

Involvement in the study will last 15-weeks and you will be asked to visit the clinic every 2-weeks. At each visit, you will be given medication to take daily (either valacyclovir or acyclovir; you will receive both medications at some point during this study). There will be a total of 9 study visits and each visit will last approximately 30 minutes. We will ask that you complete a daily symptom diary and collected daily home swabs 4-times a day, everyday during the study. Each daily home swab will take less than 3 minutes to perform.

Conditions

  • Genital Herpes

Interventions

DRUG

acyclovir

800 mg orally three times daily for 7 weeks

DRUG

valacyclovir

500 mg orally once daily for 7 weeks

Sponsors & Collaborators

Principal Investigators

  • Christine Johnston, MD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2008-12-31
Completion
2011-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00362297 on ClinicalTrials.gov