26
Participants
Start Date
July 18, 2019
Primary Completion Date
February 17, 2023
Study Completion Date
February 23, 2023
Rilpivirine
Rilpivirine 25 mg tablets for the 25 mg daily dose, or tablets for or a weight-adjusted dose. Administered orally once daily.
ARV Background Regimen
The investigator-selected ARVs, including but not limited to N(t)RTIs (example, azidothymidine \[AZT\], abacavir \[ABC\], tenofovir alafenamide \[TAF\], or tenofovir disoproxil fumarate \[TDF\] in combination with emtricitabine \[FTC\] or lamivudine \[3TC\]), whichever are approved and marketed or considered local standard of care for children aged between 2 and \< 12 years in a particular country are to be administered. Integrase inhibitors (for example, dolutegravir \[DTG\] or raltegravir) can also be administered in combination with RPV, as appropriate.
Family Clinical Research Unit FAM-CRU, Tygerberg
Josha Research, Bloemfontein
Joint Clinical Research Centre, Kampala
Siriraj Hospital Mahidol University, Bangkok
Bamrasnaradura Infectious Disease Institute, Nonthaburi
ASST Spedali Civili di Brescia, Brescia
Hosp. Univ. 12 de Octubre, Madrid
Hosp. Univ. La Paz, Madrid
Research Institute for Health Sciences, Chiang Mai
Azienda Ospedaliera Universitaria Federico II, Napoli
IRCCS Ospedale Pediatrico Bambino Gesu, Roma
Uls Santa Maria - Hosp. Santa Maria, Lisbon
Uls Sao Joao - Hosp. Sao Joao, Porto
Hosp. Sant Joan de Deu, Esplugues de Llobregat
Janssen Research & Development, LLC
INDUSTRY