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Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 (BV/HSV-2) Shedding Study
This study is currently recruiting participants.
Verified by University of Pittsburgh, October 2008
First Received: April 19, 2007   Last Updated: October 22, 2008   History of Changes
Sponsor: University of Pittsburgh
Information provided by: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00464542
  Purpose

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.


Condition Intervention Phase
Bacterial Vaginosis
Drug: metronidazole
Phase IV

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Crossover Assignment, Efficacy Study
Official Title: Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 Shedding

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • HSV-2 shedding [ Time Frame: daily for approximately 60 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: December 2007
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: metronidazole
po, 500 mg, BID, 7 days

  Eligibility

Ages Eligible for Study:   18 Years to 26 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00464542

Contacts
Contact: Thomas L Cherpes, MD 412 641 1999 cherpestl@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
University of Pittsburgh, Magee Womens Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15237
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Thomas L Cherpes Univerisity of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh ( Thomas L. Cherpes )
Study ID Numbers: PRO07030124
Study First Received: April 19, 2007
Last Updated: October 22, 2008
ClinicalTrials.gov Identifier: NCT00464542     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
herpes simplex virus

Additional relevant MeSH terms:
Herpes Simplex
Bacterial Infections
Anti-Infective Agents
Metronidazole
Antiprotozoal Agents
Skin Diseases
Physiological Effects of Drugs
Vaginitis
Vaginal Diseases
Pharmacologic Actions
Herpesviridae Infections
Virus Diseases
Skin Diseases, Viral
Genital Diseases, Female
Antiparasitic Agents
Skin Diseases, Infectious
Vaginosis, Bacterial
Radiation-Sensitizing Agents
Therapeutic Uses
DNA Virus Infections

ClinicalTrials.gov processed this record on February 08, 2010