About the D2 Project

Despite global prevention initiatives, MTCT remains a major route of HIV infection. In sub-Saharan Africa, over 1 in 5 HIV-infected pregnant women are diagnosed in late pregnancy each year, and represent the group most likely to transmit HIV to their infants due to delayed initiation of combination antiretroviral therapy (cART). Since risk of MTCT is directly related to maternal HIV viral load, HIV drugs which result in very fast rates of viral load decline may be more effective at preventing MTCT of HIV, and make the global goal of elimination of MTCT more likely to be achieved. Dolutegravir is a new agent which results in significantly faster viral load declines than Efavirenz-based therapy, which is the current first line in sub-Saharan Africa. The DolPHIN 2 project will assess whether dolutegravir is superior to efavirenz in mothers initiating cART in the third trimester of pregnancy (third trimester) in achieving undetectable HIV viral load at delivery, which is the only validated proxy for reducing risk of vertical transmission of HIV. A clinical trial will recruit 250 late presenting HIV pregnant women who will be randomised 1:1 to DTG- or EFV-containing cART. The DolPHIN-2 trial is designed to yield high-quality evidence on the efficacy and safety of DTG to allow definitive recommendations, and operational guidance to be established for use of DTG to reduce MTCT in this high-risk scenario.

A clinical trial will recruit 250 late presenting HIV pregnant women who will be randomised 1:1 to DTG- or EFV-containing cART, mothers and infants will be followed up from initiation until weaning of the infant or 18 months post-partum (whichever is the earlier). The DolPHIN-2 trial is designed to yield high-quality evidence on the efficacy and safety of DTG to allow definitive recommendations, and operational guidance to be established for use of DTG to reduce MTCT in this high-risk scenario.

In addition to trial, qualitative and pharmacoeconomic studies will further support the implementation of dolutegravir.

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