Official Title: “Valacyclovir for the Reduction of HSV-2 and BV Recurrence Rates”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: June 2009

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• The presence of genital lesions consistent with a clinical recurrence of HSV-2.
  • Time Frame: within 90 days of enrollment
    Safety Issue?: No

Secondary 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
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 40 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Pittsburgh

Overall Clinical Trial Officials and Contacts

Thomas L Cherpes, MD Principal Investigator University of Pittsburgh  

Overall Contact: Ingrid Macio, PA-C 412-641-5455 imacio@mail.magee.edu

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00682721

Study ID Number: PRO 07110164

ClinicalTrials.gov Identifier: NCT00682721

Health Authority: United States: Institutional Review Board