Clinical trial NCT00682721: Valacyclovir Suppression to Improve the Stability of Vaginal Flora Among HSV-2 Seropositive Women
Official title: Valacyclovir Suppression to Improve the Stability of Vaginal Flora Among HSV-2 Seropositive Women
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Bacterial Vaginosis
Herpes Simplex Virus Type II
Keywords: Bacterial Vaginosis
Herpes Simplex Virus Type II
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2008-05-22
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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 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

Primary outcomes:
measure: The primary endpoint of this study will be a determination of the ability of valacyclovir suppressive therapy to stabilize the vaginal flora.
timeFrame: within 90 days of enrollment
Secondary outcomes:
measure: The frequency of detection of HSV-2 in the lower genital tract at the follow up visits.
timeFrame: within 90 days of enrollment
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital of UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Thomas L Cherpes, MD
role: PRINCIPAL_INVESTIGATOR
References: