Expired Study
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Pittsburgh, Pennsylvania 15213


Purpose:

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.


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


NCT ID:

NCT00682721


Primary Contact:

Principal Investigator
Thomas L Cherpes, MD
University of Pittsburgh


Backup Contact:

N/A


Location Contact:

Pittsburgh, Pennsylvania 15213
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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