Trial Parameters
Eligibility Fast-Check
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Brief Summary
A randomised, open label, controlled PK standard of care vs doravirine plus 2 nucleoside reverse transcriptase inhibitors backbone in pregnant women initiating combination antiretroviral therapy in the second trimester of pregnancy.
Eligibility Criteria
Inclusion Criteria: * Women ≥ 18 years old * Ability to give informed consent prior to participation * Willing and able to comply with all study requirements * HIV positive * Pregnant (initiating cART ≥ 12 weeks and \< 26 weeks gestation) * Intention to breastfeed postpartum Exclusion Criteria: * Received any cART in preceding 6 months * Chronic hepatitis B (HBV) infection with clinical evidence of transaminitis * Elevations in serum levels of alanine aminotransferase (ALT) \> 5 times the upper limit of normal (ULN) or ALT \> 3xULN and bilirubin \>2xULN (with \> 35 % direct bilirubin) * Previous documented failure of an NNRTI-containing cART regimen * Previous history of hypersensitivity to any ARV * Concomitant medication which are inducers of SoC and DOR metabolism (e.g. rifampicin, anti-epileptic agents, rifabutin, St John's Wort, mitotane, enzalutamide, lumacaftor). Contraindicated medications can be found on Liverpool Drug Interactions website (hiv-druginteractions.org) * Particip