Phase 4
N=12
Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 (BV/HSV-2) Shedding Study
Bacterial Vaginosis
Bottom Line
View on ClinicalTrials.gov: NCT00464542 ↗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
| Outcome | Result | p-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
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.