Bacterial Vaginosis, Herpes Simplex Virus Type II
Conditions
Keywords
Bacterial Vaginosis, Herpes Simplex Virus Type II
Brief summary
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.
Interventions
DRUGPlacebo
Matching placebo two pills once daily
DRUGValacyclovir
1 gram daily x number of days active in the study
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| The frequency of detection of HSV-2 in the lower genital tract at the follow up visits. | within 90 days of enrollment |
Countries
United States
Outcome results
None listed