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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT00682721
Status
Withdrawn

Conditions

  • Bacterial Vaginosis
  • Herpes Simplex Virus Type II

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Matching placebo two pills once daily
  • Valacyclovir — DRUG
    1 gram daily x number of days active in the study

Study Details

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.

Key Dates

Start date
Feb 28, 2009
Status verified
Feb 2012
Primary completion
Sep 30, 2010
Completion
Sep 30, 2010

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: 2
    Valacyclovir 1 gm daily x number of days active in the study
  • Placebo Comparator: 1

Primary Outcome Measure

The primary endpoint of this study will be a determination of the ability of valacyclovir suppressive therapy to stabilize the vaginal flora. [ Time Frame: within 90 days of enrollment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Magee-Womens Hospital of UPMCPittsburghPennsylvania15213-

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By research site
Magee-Womens Hospital of UPMC· Pittsburgh, PA

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