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

Primary Purpose

Bacterial Vaginosis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Metronidazole
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Vaginosis focused on measuring herpes simplex virus

Eligibility Criteria

18 Years - 26 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Pittsburgh
  • University of Pittsburgh, Magee Womens Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Metronidazole

Arm Description

Observational before and after treatment Drug: Metronidazole 500 mg, taken by mouth, two times a day, 7 days

Outcomes

Primary Outcome Measures

Number of Participants With Bacterial Vaginosis Recurrence
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
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

Full Information

First Posted
April 19, 2007
Last Updated
April 5, 2017
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT00464542
Brief Title
Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 (BV/HSV-2) Shedding Study
Acronym
MASH
Official Title
Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 Shedding
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis
Keywords
herpes simplex virus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metronidazole
Arm Type
Other
Arm Description
Observational before and after treatment Drug: Metronidazole 500 mg, taken by mouth, two times a day, 7 days
Intervention Type
Drug
Intervention Name(s)
Metronidazole
Other Intervention Name(s)
Flagyl
Intervention Description
500 mg, taken by mouth, two times a day, 7 days
Primary Outcome Measure Information:
Title
Number of Participants With Bacterial Vaginosis Recurrence
Description
Bacterial vaginosis, defined as any vaginal smear with a Nugent score of 7-10 during the 30 day period following cessation of metronidazole therapy.
Time Frame
30 days after cessation of metronidazole therapy
Secondary Outcome Measure Information:
Title
Median Time to Bacterial Vaginosis During the 30 Days After Cessation of Metronidazole Therapy
Description
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
Time Frame
30 days after cessation of metronidazole therapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas L Cherpes
Organizational Affiliation
Univerisity of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Pittsburgh, Magee Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15237
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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