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

NCT00464542 | Completed Phase 4 Results

• 1 other identifier: PRO07030124
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

Bacterial Vaginosis

Keywords

herpes simplex virus

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days after cessation of metronidazole therapy

Secondary Outcomes (1)

• Median Time to Bacterial Vaginosis During the 30 Days After Cessation of Metronidazole Therapy

  30 days after cessation of metronidazole therapy

Study Arms (1)

Metronidazole

OTHER

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

Drug: Metronidazole

Interventions

Metronidazole DRUG

500 mg, taken by mouth, two times a day, 7 days

Also known as: Flagyl

Metronidazole

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (2)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Pittsburgh, Magee Womens Hospital

Pittsburgh, Pennsylvania, 15237, United States

Location

MeSH Terms

Conditions

Vaginosis, Bacterial; Herpes Simplex

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Inadequate controls (study would have been improved by inclusion of women without herpes simplex virus type 2 infection) to better determine the strength of the association between recalcitrance of BV and HSV-2 infection.

Results Point of Contact

• Title: Thomas Cherpes
• Organization: University of Pittsburgh

cherpestl@upmc.edu

412 692 5930

Study Officials

• Thomas L Cherpes

  Univerisity of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2007
• First Posted: April 23, 2007
• Study Start: December 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: May 11, 2017
• Results First Posted: October 4, 2011

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)