About DolPHIN 2
Mother-to-child transmission of HIV is entirely preventable and we have a duty to ensure HIV is not handed down across generations - Professor Saye Khoo, Chief Investigator
Despite global prevention initiatives, mother to child transmission (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 (DTG) is a new agent which results in significantly faster viral load declines than Efavirenz (EFV)-based therapy, which is the current first line in sub-Saharan Africa.
The DolPHIN 2 clinical trial assesses 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. The trial is designed to yield high-quality evidence on the efficacy and safety of dolutegravir to allow definitive recommendations, and operational guidance to be established for use of dolutegravir to reduce MTCT in this high-risk scenario. The trial will recruit 250 late presenting HIV+ pregnant women who will be randomised 1:1 to DTG- or EFV-containing cART.
In addition to trial, qualitative and pharmacoeconomic studies will further support the implementation of dolutegravir.
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