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Phase 4 Completed N=12 Treatment

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

Source: ClinicalTrials.gov NCT00464542 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Oct 2011
Primary outcomePrimary: Number of Participants With Bacterial Vaginosis Recurrence — 8 Participants

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.

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

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. Informational only — not medical advice.

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