PREG ART
protecting mother and baby
Safety and efficacy of Dolutegravir and EFV400 for pregnant and breastfeeding women: a randomized non-inferiority clinical trial
What We Do
PREGART is an international Phase-4 randomized clinical trial comparing the efficacy and safety of dolutegravir-based versus low-dose efavirenz-based first-line antiretroviral regimens in women living with HIV during pregnancy. Conducted across Ethiopia and Uganda, the trial enrolls 1,156 mother-infant pairs and focuses on three primary outcomes: viral suppression at delivery, prevention of mother-to-child HIV transmission, and adverse pregnancy outcomes.
The primary aim of the PREGART clinical trial is to identify safe and efficacious cART regimens for pregnant and breastfeeding women living with HIV. The trial will provide evidence-based recommendations for national, regional, and international policymakers, including WHO, on optimal ART regimens for this population.
Our Story
Launched in June 2019, PREGART brings together four partner institutions — Hawassa University (Ethiopia), Makerere University (Uganda), Karolinska Institutet (Sweden), and the Italian National Institute of Health — in a shared effort to reduce health inequities for pregnant and breastfeeding women living with HIV. The project was initially funded under the European and Developing Countries Clinical Trials Partnership (EDCTP2), part of the EU’s Horizon 2020 framework.
With renewed funding now secured under EDCTP3, the consortium continues its work to complete the trial and deliver the evidence-based recommendations that policymakers and health institutions worldwide need to update treatment guidelines.
Discover our progress and milestones in our ARCHIVE
Let us introduce ourselves:
FOCUS
PREGART 2 Project Officially Launched in Kampala to Advance Maternal and Pediatric HIV Research
The PREGART consortium has officially launched PREGART 2, a major continuation of the PREGART research programme, during its Annual Meeting held in Kampala from 11–13 February 2026. The project is coordinated by Karolinska Institutet under the leadership of Prof....