Overview

Estrogen, Probiotics and Vaginal Health to Prevent HIV Infection in ACB Women

Status:
Recruiting
Trial end date:
2022-03-31
Target enrollment:
Participant gender:
Summary
This study will enrol African, Caribbean and Black (ACB) women who are known to have a more diverse vaginal microbiome, higher rates of bacterial vaginosis with lower numbers of protective lactobacilli, and are at increased risk for HIV. The investigators will evaluate the safety, feasibility, effect on the vaginal bacterial microbiome and changes in local immune and inflammatory responses with the administration of vaginal estrogen alone, vaginal estrogen in combination with oral or vaginally administered probiotics, or vaginal probiotics alone.
Phase:
Phase 1
Details
Lead Sponsor:
McMaster University
Collaborator:
CIHR Canadian HIV Trials Network
Treatments:
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Estrogens
Polyestradiol phosphate
Probenecid