Valacyclovir Suppression to Improve the Stability of Vaginal Flora Among HSV-2 Seropositive Women
Information source: University of Pittsburgh
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bacterial Vaginosis; Herpes Simplex Virus Type II
Intervention: Placebo (Drug); Valacyclovir (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: University of Pittsburgh Official(s) and/or principal investigator(s):
Thomas L Cherpes, MD, Principal Investigator, Affiliation: University of Pittsburgh
Overall contact:
Ingrid Macio, PA-C, Phone: 412-641-5455, Email: imacio@mail.magee.edu
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.
Clinical Details
Official title: Valacyclovir Suppression to Improve the Stability of Vaginal Flora Among HSV-2 Seropositive Women
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: The primary endpoint of this study will be a determination of the ability of valacyclovir suppressive therapy to stabilize the vaginal flora.
Secondary outcome: The frequency of detection of HSV-2 in the lower genital tract at the follow up visits.
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Female.
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
Locations and Contacts
Ingrid Macio, PA-C, Phone: 412-641-5455, Email: imacio@mail.magee.edu
Magee-Womens Hospital of UPMC, Pittsburgh, Pennsylvania 15213, United States
Additional Information
Starting date: February 2009
Ending date: September 2010
Last updated: February 3, 2009
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