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Trial record 35 of 127 for:    HSV-2

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

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ClinicalTrials.gov Identifier: NCT00464542
Recruitment Status : Completed
First Posted : April 23, 2007
Results First Posted : October 4, 2011
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE April 19, 2007
First Posted Date  ICMJE April 23, 2007
Results First Submitted Date  ICMJE March 22, 2011
Results First Posted Date  ICMJE October 4, 2011
Last Update Posted Date May 11, 2017
Study Start Date  ICMJE December 2007
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 19, 2007)
HSV-2 shedding
Change History Complete list of historical versions of study NCT00464542 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2011)
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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 (BV/HSV-2) Shedding Study
Official Title  ICMJE Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 Shedding
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bacterial Vaginosis
Intervention  ICMJE Drug: Metronidazole
500 mg, taken by mouth, two times a day, 7 days
Other Name: Flagyl
Study Arms  ICMJE Metronidazole
Observational before and after treatment Drug: Metronidazole 500 mg, taken by mouth, two times a day, 7 days
Intervention: Drug: Metronidazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 31, 2011)
12
Original Enrollment  ICMJE
 (submitted: April 19, 2007)
35
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 26 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00464542
Other Study ID Numbers  ICMJE PRO07030124
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas L Cherpes Univerisity of Pittsburgh
PRS Account University of Pittsburgh
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP