A Study of Switching to RPV Plus Other ARVs in HIV-1-infected Children (Aged 2 to <12 Years) Who Are Virologically Suppressed

PHASE2CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

July 18, 2019

Primary Completion Date

February 17, 2023

Study Completion Date

February 23, 2023

Conditions
HIV
Interventions
DRUG

Rilpivirine

Rilpivirine 25 mg tablets for the 25 mg daily dose, or tablets for or a weight-adjusted dose. Administered orally once daily.

DRUG

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.

Trial Locations (14)

7505

Family Clinical Research Unit FAM-CRU, Tygerberg

9301

Josha Research, Bloemfontein

10005

Joint Clinical Research Centre, Kampala

10700

Siriraj Hospital Mahidol University, Bangkok

11000

Bamrasnaradura Infectious Disease Institute, Nonthaburi

25123

ASST Spedali Civili di Brescia, Brescia

28041

Hosp. Univ. 12 de Octubre, Madrid

28046

Hosp. Univ. La Paz, Madrid

50200

Research Institute for Health Sciences, Chiang Mai

80131

Azienda Ospedaliera Universitaria Federico II, Napoli

00165

IRCCS Ospedale Pediatrico Bambino Gesu, Roma

1649 035

Uls Santa Maria - Hosp. Santa Maria, Lisbon

4200 319

Uls Sao Joao - Hosp. Sao Joao, Porto

08950

Hosp. Sant Joan de Deu, Esplugues de Llobregat

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT04012931 - A Study of Switching to RPV Plus Other ARVs in HIV-1-infected Children (Aged 2 to <12 Years) Who Are Virologically Suppressed | Biotech Hunter | Biotech Hunter