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Valacyclovir for the Reduction of HSV-2 and BV Recurrence Rates
This study is not yet open for participant recruitment.
Verified by University of Pittsburgh, May 2008
Sponsored by: University of Pittsburgh
Information provided by: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00682721
  Purpose

This study will evaluate the effect of daily valacyclovir suppression (versus placebo) on genital shedding of the herpes virus in women who have BV. Suppression means giving medication regularly to attempt to stop the shedding of the virus. All women will also be treated with a one-week course of oral (by outh) metronidazole to treat the BV. The active medications for this study (valacyclovir and metronidazole) are standard treatments for herpes suppression and BV, respectively, and are Center for Disease Control (CDC) approved medications for the treatment of these infections.


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

MedlinePlus related topics: Herpes Simplex
Drug Information available for: Valaciclovir Valacyclovir hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Valacyclovir for the Reduction of HSV-2 and BV Recurrence Rates

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • The presence of genital lesions consistent with a clinical recurrence of HSV-2. [ 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 ]

Estimated Enrollment: 270
Study Start Date: June 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
2: Active Comparator
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
1: Placebo Comparator 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

Pre-Screening Inclusion Criteria:

  • Women 18-40 years of age at the time of screening
  • Willingness to be screened for bacterial vaginosis (BV)
  • Willing to self-collect two Q-tip like vaginal swabs

Screening Inclusion Criteria:

  • Women 18-40 years of age at the time of screening
  • Diagnosed with BV, clinically, by one of the clinician co-investigators of the protocol
  • 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, hormonal birth control, consistent condom use, bilateral tubal ligation, partner with a vasectomy)

Enrollment Inclusion Criteria:

  • Women 18-40 Years of age at the time of screening
  • Women who meet the following Amsel (by investigator assessment) and Nugent Criteria for the diagnosis of BV 3 or more Amsel criteria

    1. Homogenous vaginal discharge
    2. Vaginal discharge pH greater than or equal to 4.7
    3. Clue cells greater than or equal to 20% of vaginal epithelial cells on saline wet mount examination of vaginal discharge
    4. Positive amine (whiff) test upon addition of potassium hydroxide to vaginal discharge

Nugent criteria:

1. Vaginal gram stain score greater than or equal to 4 Subjects will be enrolled based on the Amsel criteria alone. Nugent scores will be performed to confirm the diagnosis of BV. Women whose gram stain is less than 4 will be replaced.

  • HSV-2 seropositive as determined by rapid HSV-2 testing
  • Willing to avoid use of any intravaginal products during study period
  • Willing to refrain from ingestion of any alcoholic beverage within 8 hours of starting study medications and willing to refrain from alcohol ingestion during course of metronidazole therapy and for 24 hours following completion
  • Capable of providing written informed consent
  • Capable of cooperating to the extent and degree required by this protocol

Pre-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

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 metronidazole or valacyclovir

Enrollment Exclusion Criteria:

  • Pregnancy (all women will have a urine pregnancy test prior to randomization and treatment)
  • Women not practicing an effective method of birth control (examples of effective methods of birth control are: women practicing abstinence, hormonal birth control, consistent condom use, bilateral tubal ligation, partner with a vasectomy)
  • nursing mother
  • Menopausal women
  • Presence of concomitant symptomatic yeast vaginitis
  • Presence of concomitant Trichomonas vaginalis infection
  • Use of any antimicrobial agents (vaginal or systemic) for the treatment of any condition within 7 days of study enrollment
  • Significant medical disorder that precludes accurate evaluation of a participants condition
  • Known immunocompromised state
  • History of significant hepatic or renal impairment
  • Sensitivity/allergy to valacyclovir or nucleoside analogues
  • history of acyclovir resistant HSV infection
  • Participation in a study using an investigational product in the past 30 days
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00682721

Contacts
Contact: Ingrid Macio, PA-C 412-641-5455 imacio@mail.magee.edu
Contact: Jamie Haggerty 412-641-5378 jhaggerty@mail.magee.edu

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

Responsible Party: University of Pittsburgh ( Thomas L. Cherpes, MD )
Study ID Numbers: PRO 07110164
Study First Received: May 16, 2008
Last Updated: May 21, 2008
ClinicalTrials.gov Identifier: NCT00682721  
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Herpes Simplex
Bacterial Infections
Skin Diseases
Vaginitis
Vaginal Diseases
Recurrence
Herpesviridae Infections
Virus Diseases
Genital Diseases, Female
Valacyclovir
Skin Diseases, Infectious
Vaginosis, Bacterial
DNA Virus Infections

Additional relevant MeSH terms:
Skin Diseases, Viral
Anti-Infective Agents
Therapeutic Uses
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009