Valacyclovir Suppression to Improve the Stability of Vaginal Flora Among HSV-2 Seropositive Women

Study Overview
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Brief Summary
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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.

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

Conditions
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Bacterial Vaginosis, Herpes Simplex Virus Type II

Intervention / Treatment
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* Drug: Placebo
* Drug: Valacyclovir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br>Valacyclovir 1 gm daily x number of days active in the study | Drug: Valacyclovir<br>* 1 gram daily x number of days active in the study<br>|
| Placebo Comparator: 1<br> | Drug: Placebo<br>* Matching placebo two pills once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint of this study will be a determination of the ability of valacyclovir suppressive therapy to stabilize the vaginal flora. |  | within 90 days of enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency of detection of HSV-2 in the lower genital tract at the follow up visits. |  | within 90 days of enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bacterial Vaginosis, Herpes Simplex Virus Type II