NCT03519503 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Heidari S, Mofenson L, Cotton MF, Marlink R, Cahn P, Katabira E
Antiretroviral drugs for preventing mother-to-child transmission of HIV: a review of potential effects on HIV-exposed but uninfected children. J Acquir Immune Defic Syndr. 2011 Aug 1;57(4):290-6. doi: 10.1097/QAI.0b013e318221c56a. Review.
Nagot N, Kankasa C, Tumwine JK, Meda N, Hofmeyr GJ, Vallo R, Mwiya M, Kwagala M, Traore H, Sunday A, Singata M, Siuluta C, Some E, Rutagwera D, Neboua D, Ndeezi G, Jackson D, Maréchal V, Neveu D, Engebretsen IMS, Lombard C, Blanche S, Sommerfelt H, Rekacewicz C, Tylleskär T, Van de Perre P; ANRS 12174 Trial Group
Extended pre-exposure prophylaxis with lopinavir-ritonavir versus lamivudine to prevent HIV-1 transmission through breastfeeding up to 50 weeks in infants in Africa (ANRS 12174): a randomised controlled trial. Lancet. 2016 Feb 6;387(10018):566-573. doi: 10.1016/S0140-6736(15)00984-8. Epub 2015 Nov 19. Erratum in: Lancet. 2019 Jun 22;393(10190):2492.
Van de Perre P, Rubbo PA, Viljoen J, Nagot N, Tylleskär T, Lepage P, Vendrell JP, Tuaillon E
HIV-1 reservoirs in breast milk and challenges to elimination of breast-feeding transmission of HIV-1. Sci Transl Med. 2012 Jul 18;4(143):143sr3. doi: 10.1126/scitranslmed.3003327. Review.

Promoting Infant Health and Nutrition in Sub-Saharan Africa (PROMISE): Safety and Efficacy of Infant Peri-Exposure Prophylaxis (PEP) to Prevent HIV-1 Transmission by Breastfeeding Mechanisms & Safety (M&S)

Details for clinical trial NCT03519503

Clinical trial NCT03519503 - References