Genital Herpes Clinical Trial
Official title:
A Randomized, Cross-Over Study to Evaluate the Suppressive Effect of High-Dose Valacyclovir Versus Once Daily Valacyclovir on Herpes Simplex Virus Type 2 Genital Shedding in Herpes Simplex Virus-2 Seropositive Adults
On 13 August 2008, this trial was submitted to ClinicalTrials.gov as modification to
NCT00362297. On 28 April 2011, the two records were split for administrative purposes and
each trial was given its own unique study record. Please refer to the "History of Changes"
on posting NCT00362297 for a detailed summary of the modifications.
The purpose of the research study is to evaluate the effectiveness of high-dose valacyclovir
compared to once daily valacyclovir for reduction of asymptomatic HSV-2 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 11-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 once daily
valacyclovir or high dose valacyclovir; you will receive both medications at some point
during this study). We will ask you to give a blood sample for liver, kidney and blood count
testing at each visit. There will be a total of 8 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.
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.
- Women of childbearing potential will undergo a urine pregnancy test. Serologic samples
for HSV-2 and HIV will be obtained. Part of the blood sample will also be used for
safety labs.
Start of Study Visit (Day 0) and Day 14, 28, 35, 42, 56, 70, and 77 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. Safety labs will be performed on day 14, 28, 35, 56, 70 and 77.
Crossover Study Visit Prior To Washout Period (Day 35-41)
Participants will not be given study drug or placebo during the 7-day washout period.
Participants will not be required to obtain swabs during the 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 77)
At the final study visit at Day 77 or for premature discontinuation, the investigator will
perform the activities at the regular study visits, with the exception of the dispensation
of study drug.
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