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Phase 4 N=12 Treatment

Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 (BV/HSV-2) Shedding Study

Bacterial Vaginosis

Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Oct 2011
Primary outcome: Primary: Number of Participants With Bacterial Vaginosis Recurrence — 8 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Metronidazole (Drug)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
University of Pittsburgh
Primary completion
Mar 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Bacterial Vaginosis Recurrence
8
SECONDARY
Median Time to Bacterial Vaginosis During the 30 Days After Cessation of Metronidazole Therapy
14

Summary

This investigation assessed the effects of asymptomatic BV on daily genital tract shedding of HSV-2 by determining shedding frequency before and after treatment of asymptomatic BV.

Eligibility Criteria

Inclusion Criteria

  • Women 18-26 years old of age
  • Only those women who deny symptoms of vaginal discharge and odor but who meet Amsel and Gram stain criteria for the diagnosis of BV will be eligible
  • Amsel criteria (3 of the following 4 conditions) (10):
  • Homogenous vaginal discharge
  • Vaginal pH > 4.5
  • Positive amine (sniff) test
  • Presence of clue cells in the vaginal fluid
  • Gram stain criteria (11):
  • Score: 0-3; classification: normal; vaginal bacteria morphotype: Lactobacillus predominant
  • Score: 4-6; classification: intermediate; vaginal bacteria morphotype: Lactobacilli reduced
  • Score: 7-10; classification: BV; vaginal bacteria morphotype: Lactobacillus replaced by Gardnerella and anaerobes
  • Eligible women will need to test positive for HSV-2 type-specific antibodies. Determination of HSV-2 serostatus will be determined by a point-of-care type-specific immunoassay kit.
  • Patients capable of providing written informed consent
  • Patients willing to refrain from the use of intravaginal products (i.e., contraceptive creams, gels, foams, sponges, lubricants, douches, etc.) during the study period
  • Patients willing to refrain from the use of any systemic or topical genital antiviral medication during the study period
  • Patients willing and capable of cooperating to the extent and degree required by this protocol

Exclusion Criteria

  • HSV-2 seronegativity (as determined by the point-of-care immunoassay)
  • Pregnancy (all women will receive a pregnancy test prior to enrollment) or those women currently not practicing an effective method of birth control
  • Current Chlamydia trachomatis, Neisseria gonorrhea, or Trichomonas vaginalis infection
  • Use of prescriptive antiviral treatment for presumed HSV reactivation within the 14 days prior to enrollment
  • Use of systemic antimicrobials within the past 14 days
  • History of hypersensitivity or inability to tolerate systemic metronidazole therapy
  • Nursing mother
  • Patients with intrauterine devices
  • Unwillingness to refrain from initiation of antiviral medication during study period
  • Unwillingness to refrain from use of douche products during study period
  • Unwillingness to refrain from the ingestion of any alcoholic beverages during the one-week course of oral metronidazole therapy
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00464542). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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