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GLOBVAC-Global helse- og vaksin.forskn

Planning meeting for the PROMISE PEP Follow-up study

Awarded: NOK 0.29 mill.

We have conducted the PROMISE PEP/ ANRS 12174 study, a randomised controlled trial comparing the efficacy and safety of prolonged infant peri-exposure prophylaxis (PreP) with lopinavir/ritonavir (LPV/r) versus lamivudine (3TC) to prevent postnatal HIV-1 t ransmission during the full duration of breastfeeding (50 weeks) (ClinicalTrials.gov # NCT00640263). The results of the study will be presented at CROI 2014 in Boston (5 March 2014). Short-term safety was good but long-term safety needs to be assessed. We intend to prepare a long-term follow-up study of the children in this trial and we hereby apply for funding to convene a 1-week workshop to develop the protocol. In two of the 4 countries we are currently conducting similar assessments of participants in a non-HIV trial of exclusive breastfeeding, the Saving Brains study in Uganda and Burkina Faso, PROMISE SB study (ClinicalTrials.gov #NCT01882335). These children will serve as a reference population for children from the PROMISE PEP/ANRS 12174 trial. There is some overlap of co-investigators in the two trials, but generally the team from PROMISE PEP/ ANRS 12174 needs to benefit from the experiences gained through the PROMISE SB study regarding follow-up design and assessments. Therefore, we plan to b ring together researchers from both the PROMISE PEP/ANRS 12174 and the PROMISE SB study with experts in neurodevelopmental assessment of children in low-resource settings for a 1 week writing workshop in Norway. The trial was conducted in 4 African site s: Ouagadougou (Burkina Faso), East London (South Africa), Mbale (Uganda) and Lusaka (Zambia). The trial enrolled 1273 infants is now completed. The preliminary analysis show that both 3TC and LPV/r achieved very low rates of transmission with an excellen t clinical tolerance and no difference between arms in terms of efficacy or safety, however, long-term outcomes remain unknown.

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GLOBVAC-Global helse- og vaksin.forskn