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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00464542
First Posted: April 23, 2007
Last Update Posted: May 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Pittsburgh
  Purpose
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.

Condition Intervention Phase
Bacterial Vaginosis Drug: Metronidazole Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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:
  • Number of Participants With Bacterial Vaginosis Recurrence [ Time Frame: 30 days after cessation of metronidazole therapy ]
    Bacterial vaginosis, defined as any vaginal smear with a Nugent score of 7-10 during the 30 day period following cessation of metronidazole therapy.


Secondary Outcome Measures:
  • Median Time to Bacterial Vaginosis During the 30 Days After Cessation of Metronidazole Therapy [ Time Frame: 30 days after cessation of metronidazole therapy ]
    The time by which half of the participants were diagnosed with bacterial vaginosis, defined as any vaginal smear with a Nugent score of 7-10 during the 30 day period following cessation of metronidazole therapy


Enrollment: 12
Study Start Date: December 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Metronidazole
Observational before and after treatment Drug: Metronidazole 500 mg, taken by mouth, two times a day, 7 days
Drug: Metronidazole
500 mg, taken by mouth, two times a day, 7 days
Other Name: Flagyl

Detailed Description:

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. Therefore, an improved understanding of the risk factors associated with HSV-2 shedding is needed.

Preliminary data suggests that bacterial vaginosis (BV) may be associated with increased genital tract shedding of HSV-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.

This study 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. Twelve HSV-2 seropositive women with asymptomatic BV were enrolled. These women were instructed to self-collect daily swab specimens for HSV-2 deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) analysis from the lower genital tract for one month. At the end of the one month follow-up visit, each participant completed a one week course of oral metronidazole for treatment of BV. This was followed by daily home collection of genital tract swab specimens for an additional one month.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 26 Years   (Adult)
Sexes 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 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00464542


Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
University of Pittsburgh, Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15237
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Thomas L Cherpes Univerisity of Pittsburgh
  More Information

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00464542     History of Changes
Other Study ID Numbers: PRO07030124
First Submitted: April 19, 2007
First Posted: April 23, 2007
Results First Submitted: March 22, 2011
Results First Posted: October 4, 2011
Last Update Posted: May 11, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Pittsburgh:
herpes simplex virus

Additional relevant MeSH terms:
Herpes Simplex
Vaginal Diseases
Vaginosis, Bacterial
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Genital Diseases, Female
Bacterial Infections
Vaginitis
Metronidazole
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents