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

Primary Purpose

Genital Herpes

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
acyclovir
valacyclovir
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Genital Herpes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Washington Virology Research Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard dose

High-dose

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 8, 2006
Last Updated
November 16, 2021
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT00362297
Brief Title
Randomized Trial to Evaluate Suppressive Effect of High-Dose Acyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genital Herpes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard dose
Arm Type
Active Comparator
Arm Title
High-dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
acyclovir
Intervention Description
800 mg orally three times daily for 7 weeks
Intervention Type
Drug
Intervention Name(s)
valacyclovir
Other Intervention Name(s)
Valtrex
Intervention Description
500 mg orally once daily for 7 weeks
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
15 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Johnston, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington Virology Research Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22225814
Citation
Johnston C, Saracino M, Kuntz S, Magaret A, Selke S, Huang ML, Schiffer JT, Koelle DM, Corey L, Wald A. Standard-dose and high-dose daily antiviral therapy for short episodes of genital HSV-2 reactivation: three randomised, open-label, cross-over trials. Lancet. 2012 Feb 18;379(9816):641-7. doi: 10.1016/S0140-6736(11)61750-9. Epub 2012 Jan 4. Erratum In: Lancet. 2012 Feb 18;379(9816):616.
Results Reference
derived

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

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