Bacterial Vaginosis
Conditions
Keywords
herpes simplex virus
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.
Interventions
DRUGMetronidazole
500 mg, taken by mouth, two times a day, 7 days
Sponsors
University of Pittsburgh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 26 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Bacterial Vaginosis Recurrence | 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
| Measure | Time frame | Description |
|---|---|---|
| Median Time to Bacterial Vaginosis During the 30 Days After Cessation of Metronidazole Therapy | 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 |
Countries
United States
Participant flow
Recruitment details
Twelve HSV-2 seropositive women with asymptomatic BV were enrolled. Two of these women were lost to follow-up within 2 weeks of enrollment. A third woman was lost to follow-up after initiating metronidazole therapy at study midpoint.
Participants by arm
| Arm | Count |
|---|---|
| MASH Cohort This cohort consisted of women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and who had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Pre-treatment | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | MASH Cohort |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 24 years STANDARD_DEVIATION 2.5 |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
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.
Time frame: 30 days after cessation of metronidazole therapy
Population: per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Post-treatment MASH Cohort | Number of Participants With Bacterial Vaginosis Recurrence | 8 Participants |
Secondary
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
Time frame: 30 days after cessation of metronidazole therapy
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Post-treatment MASH Cohort | Median Time to Bacterial Vaginosis During the 30 Days After Cessation of Metronidazole Therapy | 14 Days |