Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 (BV/HSV-2) Shedding Study
Information source: University of Pittsburgh
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bacterial Vaginosis
Intervention: metronidazole (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Pittsburgh Official(s) and/or principal investigator(s):
Thomas L Cherpes, Principal Investigator, Affiliation: Univerisity of Pittsburgh
Overall contact:
Thomas L Cherpes, MD, Phone: 412 641 1999, Email: cherpestl@upmc.edu
Summary
An important contributor to the epidemic spread of herpes simplex virus type 2 (HSV-2) is
its high frequency of asymptomatic shedding in the genital tract, as transmission usually
occurs during these periods of subclinical reactivation of the virus (1). Therefore, an
improved understanding of the risk factors associated with HSV-2 shedding is needed.
The researchers' preliminary data suggests that bacterial vaginosis (BV) may be associated
with increased genital tract shedding of HSV-2 (2). As BV is the most common cause of
vaginal symptoms in reproductive age women, even modest associations with genital tract
shedding of HSV-2 would result in substantial attributable risks for transmission of the
virus.
The researchers' investigation will assess the effects of asymptomatic BV on daily genital
tract shedding of HSV-2 by determining shedding frequency before and after treatment of
asymptomatic BV. To do this, the researchers will enroll 35 HSV-2 seropositive women with
asymptomatic BV. These women will be instructed to self-collect daily swab specimens for
HSV-2 DNA PCR analysis from the lower genital tract for one month. At the end of the one
month follow-up visit, each participant will complete a one week course of oral
metronidazole for treatment of BV. This will be followed by daily home collection of
genital tract swab specimens for an additional one month.
Clinical Details
Official title: Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 Shedding
Study design: Treatment, Non-Randomized, Open Label, Historical Control, Crossover Assignment, Efficacy Study
Primary outcome: HSV-2 shedding
Eligibility
Minimum age: 18 Years.
Maximum age: 26 Years.
Gender(s): Female.
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 morphophyte: Lactobacillus
predominant
- Score: 4-6; classification: intermediate; vaginal bacteria morphophyte: Lactobacilli
reduced
- Score: 7-10; classification: BV; vaginal bacteria morphophyte: Lactobacillus replaced
by Gardnerella and anaerobes
It has been reported that 50% of women who meet clinical criteria for BV will deny
symptoms (12).
In addition, routine antimicrobial treatment of women with asymptomatic BV is not
currently recommended by the Centers for Disease Control (13).
- 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 (biokitHSV-2 Rapid Test, biokit USA).
- 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 POC 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
Locations and Contacts
Thomas L Cherpes, MD, Phone: 412 641 1999, Email: cherpestl@upmc.edu
University of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States; Not yet recruiting
University of Pittsburgh, Magee Womens Hospital, Pittsburgh, Pennsylvania 15237, United States; Recruiting
Additional Information
Starting date: December 2007
Last updated: October 22, 2008
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