Safety and efficacy of Dolutegravir and EFV400 for pregnant and breastfeeding women - a randomized non-inferiority clinical trialcore
PREGART · Horizon Europe grant · 2026-01-01–2028-12-31
EC contribution
Total cost
Beneficiaries
About the data
Source: CORDIS (official EU open data), Horizon Europe. Framework HORIZON · call HORIZON-JU-GH-EDCTP3-2023-01 · scheme HORIZON-JU-RIA · topic HORIZON-JU-GH-EDCTP3-2023-01-02. CORDIS record →
Objective
PREGART is a multi-national Phase-4 randomized clinical trial aimed at identifying optimal antiretroviral treatment (ART) regimens by comparing the efficacy and safety of dolutegravir- versus low-dose efavirenz (EFV400mg-) based first-line cART regimens in 1156 HIV-infected pregnant women and infant pairs in Ethiopia and Uganda. The primary outcomes are undetectable viral load at delivery, prevention of mother-to-child transmission of HIV, and adverse pregnancy outcomes. The COVID-19 pandemic significantly hampered all trial activities, including patient enrollment, follow-up, regulatory approvals, and trial site initiation. All clinical trial activities were suspended to protect the safety of study participants (pregnant women and infants) following the stay-at-home orders during the initial wave (March - September 2020) and intermittently during the subsequent waves of COVID-19. Furthermore, the PREGART trial activity was affected by the civil war in northern Ethiopia (2021/22) and the Ebola disease outbreak in Uganda (2022/23). Efforts have been made to mitigate these challenges by opening new trial sites, adapting protocols, and utilizing decentralized trial approaches to increase the participant recruitment rate. To complete the PREGART clinical trial, we request another 36 months and 1.8 million euros to compensate for time and incurred financial loss due to the COVID-19 pandemic, the civil war in Ethiopia, and the Ebola outbreak in Uganda. Completion of clinical trial activities and data analysis will fulfill our obligation to protect the scientific quality and data integrity, ensuring our commitments to study participants and meet PREGART trial objectives - to provide comprehensive and statistically powered evidence for policymakers on the maternal and infant safety and efficacy of dolutegravir and EFV 400mg containing cART. The study will contribute towards optimizing WHO and regional ART guidelines for HIV-infected pregnant and breastfeeding women.
Beneficiaries (4)
| Organisation | Country | Role | EC contribution | SME |
|---|---|---|---|---|
| KAROLINSKA INSTITUTET | SE | coordinator | €500,000 | |
| MAKERERE UNIVERSITY | UG | participant | €600,000 | |
| HAWASSA UNIVERSITY | ET | participant | €600,000 | |
| ISTITUTO SUPERIORE DI SANITA | IT | participant | €100,000 |
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