The first women were enrolled in the sparse PK sub-study in Gabon and Mozambique in January 2021. The rich-PK will require hospitalization of the participants to facilitate sample collection at specified time points and will start soon.
Despite of the difficulties following COVID-19 pandemic, 332 women were enrolled in the clinical trial on 28th October 2020, which means that half of the sample size has already been achieved. The recruitment is expected to end on 31st August 2021.
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.
In order to overcome the recruitment pitfalls in Gabon, the CISM expanded enrolment of participants to nearby Palmeira health post on 16th September 2020. It is estimated that approximately 100 participants will be enrolled in Palmeira in 12 months. The first participant was recruited on the same day the screening of potential participants started.
Despite the challenges related to the COVID-19 pandemic, the CERMEL team managed to set up a second recruiting site in Gabon, at the Jeanne Ebory Hospital, in Libreville. Screening of potential participants started on 19th May 2020 and few weeks after the first participant was recruited (10th June). The opening of this second site was already planned in the original design of the study to increase the number of participants enrolled in the country.
The screening of potential participants started on 25th November 2019 in Manhiça and the first participant was enrolled on 26th November 2019. Participants in the trial receive the first dose of the treatment at the antenatal care visit and the two subsequent administrations (in the two following days) at home. During these visits, the corresponding treatment is administered and the correct use of the LLITNs is monitored.
The screening of potential participants started on 18th September 2019 and the first participant was recruited on 20th September 2019. As part of the study, she was allocated to one of the study arms in a blinded way, received HIV treatment, cotrimoxazole prophylaxis and a long lasting insecticide treated net (LLITN). The achievement of this project milestone constitutes the starting point of the clinical trial, where a total of 664 women will be enrolled.
In order to set up the study, the study materials and drugs were delivered to our partners in Gabon in March 2019 and in Mozambique in October 2019. A second batch of drugs will be produced and delivered at the end of 2020, to be able to complete the trial. The participation of MMV in the project has helped to procure quality assured DHA-PPQ and placebo from qualified manufacturers.
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