Official Title: “Valacyclovir Suppression to Improve the Stability of Vaginal Flora Among HSV-2 Seropositive Women”

We will be examining the effects of suppressive valacyclovir therapy on the stability of vaginal flora in women who are seropositive for HSV-2. We have preliminary data that suggests the presence of HSV-2 increases the risk for Group B Streptococcus colonization as well as many other deleterious organisms (e.g. Streptococcus pseudoporcinus), in addition to increasing the risk for acquisition of BV-associated vaginal flora. We will be examining the effects of suppressive therapy on the vaginal flora of any HSV-2 seropositive woman.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: September 2010

Intervention(s) in this Clinical Trial

• Drug: Placebo
  • Matching placebo two pills once daily
• Drug: Valacyclovir
  • 1 gram daily x number of days active in the study

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 2
  • Valacyclovir 1 gm daily x number of days active in the study
• Placebo Comparator: 1

Primary Measures

• The primary endpoint of this study will be a determination of the ability of valacyclovir suppressive therapy to stabilize the vaginal flora.
  • Time Frame: within 90 days of enrollment
    Safety Issue?: No

Secondary Measures

• The frequency of detection of HSV-2 in the lower genital tract at the follow up visits.
  • Time Frame: within 90 days of enrollment
    Safety Issue?: No

Screening Inclusion Criteria:

• Women 18-40 years of age at the time of screening
• Willing to be screened for HSV-2 using a rapid, FDA approved test
• Using an effective method of birth control (examples of effective methods of birth control are: women practicing abstinence x 90 days, hormonal birth control, consistent condom use, bilateral tubal ligation, partner with a vasectomy)

Screening Exclusion Criteria:

• Pregnant or nursing mother
• Use of any antimicrobial agents (vaginal or systemic) for the treatment of any condition within 7 days
• Presence of any intrauterine device
• Allergy or hypersensitivity to valcyclovir or nucleoside analogues

Enrollment Inclusion Criteria:

• Women 18-40 Years of age at the time of screening
• HSV-2 seropositive as determined by rapid HSV-2 testing
• Using an effective method of birth control (examples of effective methods of birth control are: women practicing abstinence x 90 days, hormonal birth control, consistent condom use, bilateral tubal ligation, partner with a vasectomy)
• Willing to avoid use of any intravaginal products during study period
• Capable of providing written informed consent
• Capable of cooperating to the extent and degree required by this protocol

Enrollment Exclusion Criteria:

• Pregnancy (all women will have a urine pregnancy test prior to randomization and treatment)
• nursing mother
• Menopausal women
• Use of any antimicrobial agents (vaginal or systemic) for the treatment of any condition within 7 days of study enrollment
• Known immunocompromised state
• Significant Medical disorder that precludes accurate evaluation of participants condition
• Presence of any intrauterine device
• History of significant hepatic or renal impairment
• Sensitivity/allergy to valacyclovir or nucleoside analogues
• history of acyclovir or valacyclovir resistant HSV infection
• Participation in a study using an investigational product in the past 30 days

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 40 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Pittsburgh

Overall Clinical Trial Officials and Contacts

Thomas L Cherpes, MD Principal Investigator University of Pittsburgh  

Overall Contact: Ingrid Macio, PA-C 412-641-5455 imacio@mail.magee.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00682721

Study ID Number: PRO 08090230

ClinicalTrials.gov Identifier: NCT00682721

Health Authority: United States: Institutional Review Board