MTN-043/B-PROTECTED – A Phase IIIb open-label study that evaluated the safety and acceptability of the monthly dapivirine ring, which is under regulatory review in several African countries, and Truvada as daily oral PrEP in women who are breastfeeding. The study enrolled 200 breastfeeding mothers and their 6- to 12-week-old babies. Women used their assigned product – oral PrEP or the dapivirine ring – for three months and were followed for an additional two weeks. B-PROTECTED was conducted between September 2020 and November 2021 at four clinical research sites in Malawi, South Africa, Uganda and Zimbabwe, where the DELIVER (MTN-042) is also being conducted. Results are anticipated in mid-2022. More info…
MTN-042/DELIVER – A Phase IIIb open-label study designed to evaluate the safety and acceptability of the monthly dapivirine vaginal ring, which is under regulatory review in several African countries, and Truvada as daily oral PrEP in pregnant women. DELIVER, which is being conducted at four trial sites in Malawi, South Africa, Uganda and Zimbabwe, is designed to be conducted in step-wise fashion, enrolling one group of women at a time, beginning with women late in pregnancy, with participants randomly assigned to use either the ring or oral PrEP until the time they deliver. The study began in February 2020 and is expected to be completed early 2023. More info…