- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00362297
Randomized Trial to Evaluate Suppressive Effect of High-Dose Acyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2
A Randomized, Cross-Over Study to Evaluate the Suppressive Effect of High-Dose Acyclovir Versus Once Daily Valacyclovir on Herpes Simplex Virus Type 2 Genital Shedding in Herpes Simplex Virus-2 Seropositive Adults
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Screening Assessment
Patients will be assessed for their eligibility to enter the study at a screening visit. After signing informed consent they will undergo a medical history and the following information will be recorded in the Case Report Form (CRF):
- Demographic Data: Date of birth, sex, marital status, education and race
- Previous antiviral medication taken
- History of sexually transmitted infections and sexual history.
Start of Study Visit (Day 0) and Day 14, 28, 42, 56, 70, 84, 98 and 105 Follow-Up Visits.
Eligible patients will return to clinic to be given study drug and a patient diary card on which to record concomitant medications, signs and symptoms, and adverse experiences. The investigator will instruct the patient on daily home viral sample collection, taking the study drug, and completing the diary card. The patient will be instructed to return to clinic in 2 weeks, +/- 2 days. Medication compliance will be assessed at each visit using pill counts.
Crossover Study Visit Prior To Washout Period (Day 49-55)
Participants will not be given study drug or placebo during the 7-day washout period.
Daily Home Viral Sample Collection
Participants will collect swabs from the genital mucosa four times per day and store the samples in PCR media with preprinted labels. Women will swab the cervicovaginal, vulvar and perianal areas, and men will swab the penile and perianal. Every two weeks, they will return the samples to the Virology Research Clinic when they present for additional study drug and assessment.
Final Study Visit (Day 105)
At the final study visit at Day 105 or for premature discontinuation, the investigator will perform the activities at the regular study visits, with the exception of the dispensation of study drug.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98104
- University of Washington Virology Research Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years or older;
- HSV-2 seropositive by Western Blot;
- not receiving any drugs with known anti-HSV-2 activity for study duration;
- history of primary genital herpes infection within past 6 months OR history of 4 or more HSV recurrences per year during the past year OR 4 or more recurrences per year prior to initiation of suppressive antiviral therapy;
- able to comply with the study protocol;
- women of child bearing potential who are sexually active with men must be using a medically accepted method of contraception as judged by the investigator;
- women of child-bearing potential must have a negative pregnancy test (urine) at screening visit;
- in general good health, without other serious medical conditions and specifically with normal renal and hepatic function, as determined by the patient's medical history;
- planning to remain resident in the area of the study center for the duration of the study participation;
- HIV seronegative.
Exclusion Criteria:
- hypersensitivity to acyclovir or valacyclovir;
- pregnant women;
- HIV positive or other immunosuppressed state, including chronic steroid use. Intermittent nasal or topical steroids are acceptable
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard dose
|
500 mg orally once daily for 7 weeks
Other Names:
|
Experimental: High-dose
|
800 mg orally three times daily for 7 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 Acyclovir as Compared to Once-daily Valacyclovir.
Time Frame: 15 weeks
|
Participants were treated with both interventions in a cross-over study design.
Shedding rates on each drug arm per participant were compared by Poisson regression.
Shedding rates were calculated by dividing the number of positive swabs by the total number of swabs for each intervention group.
|
15 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christine Johnston, MD, University of Washington
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 30520-D - Phase 1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Genital Herpes
-
EMSCompleted
-
NovartisCompletedRecurrent Genital HerpesAustralia
-
Kaiser PermanentePatient-Centered Outcomes Research InstituteRecruitingMaternal Morbidity | Racial Disparities | Genital Herpes SimplexUnited States
-
UBP Greater China (Shanghai) Co., LtdNot yet recruiting
-
UBP Greater China (Shanghai) Co., LtdNot yet recruiting
-
Starpharma Pty LtdNational Institute of Allergy and Infectious Diseases (NIAID)CompletedHIV Infections | HSV-2 Genital HerpesAustralia
-
Genocea Biosciences, Inc.CompletedGenital Herpes Simplex Type 2United States
-
Labo'LifeTerminated
-
BioNTech SERecruiting
-
VicalCompletedGenital Herpes Simplex Type 2United States
Clinical Trials on valacyclovir
-
Candel Therapeutics, Inc.Active, not recruitingProstate CancerUnited States, Puerto Rico
-
Radboud University Medical CenterCompletedBioequivalence Study in Healthy Volunteers of a New Paediatric Formulation of Valacyclovir (VALID-I)Varicella Zoster Virus Infection | Herpes Simplex Virus InfectionNetherlands
-
Dr. Reddy's Laboratories LimitedCompleted
-
Dr. Reddy's Laboratories LimitedCompleted
-
GlaxoSmithKlineCompletedHerpes LabialisUnited States
-
University of MinnesotaCompletedEpstein-Barr Virus Infections | Cytomegalovirus Infections | Transplantation InfectionUnited States
-
Bristol-Myers SquibbCompletedHerpes Zoster | Shingles
-
National Institute of Allergy and Infectious Diseases...Glaxo WellcomeWithdrawnHIV Infections | Herpes Simplex | Chickenpox
-
GlaxoSmithKlineTerminatedHerpes GenitalisUnited States, Australia, Hong Kong
-
Yung Shin Pharm. Ind. Co., Ltd.CompletedHerpes ZosterTaiwan