Age Range
4 - 11
Trial Purpose
Leli yiqembu elilodwa, elebula elivulekile, ucwaningo lwezindawo eziningi kubahlanganyeli bezingane abanokutheleleka kwe-human immunodeficiency virus uhlobo 1 (HIV-1), abaneminyaka engamaviki angu-4 kuya <iminyaka engu-12 futhi banesisindo esingu-<45 kg, abangenazo i-treatment-naive (TN) noma abaye bacindezelwa nge-virologically (VS) ekuhlulekeni kokwelashwa kwe-antiretroviral okuzinzile kwezinyanga3 zenhlanganisela eqinile ye-antiretroviral yokwehluleka. Inhloso yokuqala eyinhloko ukuhlola isimo esizinzile se-pharmacokinetics (PK) ye-doravirine (DOR) [MK-1439] lapho inikezwa kuhlanganiswe ne-2 nucleoside/nucleotide analog reverse transcriptase inhibitors (NRTIs) noma njengengxenye yenhlanganisela yomthamo ongaguquki (FDC) we-DOR/lamiproxiTrofonofonofonofonofolio ababambiqhaza ≥6 kuya <iminyaka engu-12 futhi nesisindo esingu-≥14 kuya ku-<45 kg. Inhloso yesibili eyinhloko ukuhlola ukuphepha nokubekezelelana kwe-DOR uma inikezwa nama-NRTI angu-2 noma njengengxenye ye-FDC ye-DOR/3TC/TDF, kubahlanganyeli ≥6 kuya eminyakeni engu-12 kanye nesisindo esingu-≥14 kuya ku-<45 kg, kuze kube Iviki 24.
NATIONAL TRIAL REFERENCE NUMBER
I-NCT04375800
EudraCT
2019-003955-13
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About The Study
Trial Phase
Trial start and end dates
- Actual study start date Februwari 3, 2021
- Estimated primary completion date Mashi 4, 2028
- Estimated study completion date Ephreli 11, 2034