Delay of the start of the pharmacokinetics study due to COVID-19 pandemic
It is urgently required to study the drug interactions of the DHA-PPQ, antiretroviral treatments and cotrimoxazole prophylaxis before large numbers of pregnant women and their infants are exposed to both drugs concomitantly. For this, a pharmacokinetics study (PK sub-study) was designed to be performed on a sub-sample of pregnant women participating in the trial. The PK sub-study expects to enroll 200 women (enrolled in two different schemes, the sparse and the rich) that are already part of the clinical trial, in order to assess potential interactions between antimalarial and antiretroviral drugs. The PK sub-study was planned to start in early 2020, however due to the COVID-19 pandemic and its related mobility restrictions, the implementation of the sub-study was postponed.