HIV/AIDS Urological and Genital Diseases
Conditions
Interventions
Metronidazole
Sponsors
Bill and Melinda Gates Foundation
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Premenopausal women, 18 – 45 years old • BV by Amsel criteria (at least 3 of 4 criteria must be present) and/or Nugent score (if symptomatic, score = 4, if asymptomatic = 7). • HIV negative or positive (up to 20 people living with HIV will be included) based on antibody test at screening. • Not pregnant at screening/enrolment visit, and unlikely to have an early pregnancy per clinician’s assessment of last menstrual period and recent sexual activity. • Literate, willing and able to provide written informed consent • Willing and able to attend study visits and comply with study procedures, including self-sampling and completion of the daily diary
Exclusion criteria
Exclusion criteria: STI positive for Chlamydia, gonorrhoea, symptomatic candidiasis or trichomoniasis positive at screening • Pregnant women • Illiterate women • Women who have had antibiotic treatment within the last 7 days • Clinically significant acute or chronic medical condition or other circumstance that in the opinion of the PI/designee makes the participant unsuitable for participation in the study or jeopardizes the safety or rights of the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the impact of a standard course of oral MDZ treatment (400 mg twice per day for 7 days) on the vaginal microbiota of South African women with BV • To characterize the level of resistance of the vaginal microbiota with high G. vaginalis relative abundance before and after BV treatment with MDZ | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the proportion of women with recurrent or persistent BV on Day 8, 16 and 24 follow-up visits. • To assess whether MDZ and clindamycin treatment levels correlate with BV-linked microbiota resistance in vivo. • To characterise re-emerging Lactobacillus species after culturing with MDZ treatment and endolysin BNT331. • To assess the in vitro efficacy of the endolysin BNT331 against Gardnerella strains and other bacterial species found within the persistent or recurrent polymicrobial outgrowth of anaerobic microbiota using the human Vagina Chip and eVOLVER models. • To establish a biobank of diverse vaginal microbiota strains isolated from samples both before and after MDZ treatment. • To evaluate new STI and BV assays • To determine the relationship between bacterial community in the vagina and that in the rectum | — |
Countries
South Africa
Contacts
Public ContactThobile Mhlongo
CAPRISA
Outcome results
None listed