Piperaquine and dolutegravir drug-drug interactions study in pregnant women

To understand the impact of standard antiretroviral therapy on the pharmacokinetic profile of piperaquine administered as dihydroartemisinin-piperaquine for intermittent preventive treatment of malaria in HIV-infected pregnant women in Malawi

This is an open-label, non-randomised, fixed sequence, pharmacokinetic clinical trial, with intense blood sampling, in 22 pregnant women living with HIV, awaiting a switch from efavirenz- to dolutegravir-based ART according to the HIV treatment policy in Malawi (PACTR201910580840196). Pregnant women will be enrolled from 16 weeks of pregnancy and will contribute blood samples; i) while on DP and efavirenz-based ART (sequence 1), ii) when taking dolutegravir-based ART alone (sequence 2), and iii) when on DP and dolutegravir-based ART (sequence 3). The primary outcome will address the question on whether dolutegravir-based ART results in better exposure of the longer acting partner drug of DP, piperaquine, compared to efavirenz-based ART (sequence 1 samples versus those from sequence 3). Additionally, we will understand if coadministration of DP and dolutegravir-based ART impacts on drug exposure of dolutegravir (sequence 2 samples versus those from sequence 3).