The DolPHIN 2 Clinical Trial is designed to yield high-quality evidence on the efficacy and safety of dolutegravir in late presenting pregnant women, to allow definitive recommendations for use of dolutegravir to reduce MTCT in this high-risk scenario.
The study commenced recruitment in January 2018 and recruited over 268 late presenting HIV+ pregnant women who were randomised 1:1 to DTG- or EFV-containing cART. The trial primary outcome analysis was presented at the Conference on Retroviruses and Opportunistic Infections (CROI) in March 2019.
Women living with HIV starting dolutegravir (DTG)-based ART after presenting in late pregnancy achieved more rapid virological suppression before delivery than those who started with an efavirenz (EFV)-based regimen.
You can learn more about the trial results by accessing the CROI presentation slides and reading our policy brief. Learn more about the day-to-day reality of the trial by following the links to the right and below.
Spotlight on the Ugandan study site
Dr Kenneth Kintu, trial manager at the IDI site, discusses the challenges and rewards of the study, and his hopes for the future.