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

This study has been withdrawn prior to enrollment.
(Sponsor has withdrawn support for this study and it will not be performed)
Sponsor:
Information provided by (Responsible Party):
Thomas L. Cherpes, MD, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00682721
First received: May 16, 2008
Last updated: February 29, 2012
Last verified: February 2012
  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.


Condition Intervention
Bacterial Vaginosis
Herpes Simplex Virus Type II
Drug: Placebo
Drug: Valacyclovir

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Valacyclovir Suppression to Improve the Stability of Vaginal Flora Among HSV-2 Seropositive Women

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The frequency of detection of HSV-2 in the lower genital tract at the follow up visits. [ Time Frame: within 90 days of enrollment ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: February 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
Valacyclovir 1 gm daily x number of days active in the study
Drug: Valacyclovir
1 gram daily x number of days active in the study
Placebo Comparator: 1 Drug: Placebo
Matching placebo two pills once daily

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682721

Locations
United States, Pennsylvania
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Thomas L Cherpes, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Thomas L. Cherpes, MD, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00682721     History of Changes
Other Study ID Numbers: PRO 08090230
Study First Received: May 16, 2008
Last Updated: February 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Bacterial Vaginosis
Herpes Simplex Virus Type II

Additional relevant MeSH terms:
Herpes Simplex
Vaginosis, Bacterial
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Bacterial Infections
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014