Study to Assess the Acceptability of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed-Dose Combination (FDC) Tablets in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Pediatric Participants, Using Matching Placebo Tablets

PHASE1CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

October 10, 2019

Primary Completion Date

March 6, 2020

Study Completion Date

March 6, 2020

Conditions
HIV-1
Interventions
DRUG

D/C/F/TAF FDC placebo

Participants will receive matching placebo tablet (whole and split) of D/C/F/TAF 675/150/200/10 mg FDC on Day 1 as intake period 1 and intake period 2.

Trial Locations (8)

28007

Hosp. Gral. Univ. Gregorio Marañon, Madrid

28041

Hosp. Univ. 12 de Octubre, Madrid

28046

Hosp. Univ. La Paz, Madrid

30308

Emory University, Atlanta

38105

St Jude Children's Research Hospital, Memphis

77030

University of Texas Health Science Center, Houston

85016

Phoenix Children's Hospital, Phoenix

08950

Hosp. Sant Joan de Deu, Esplugues de Llobregat

All Listed Sponsors
lead

Janssen Pharmaceutica N.V., Belgium

INDUSTRY

NCT04006704 - Study to Assess the Acceptability of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed-Dose Combination (FDC) Tablets in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Pediatric Participants, Using Matching Placebo Tablets | Biotech Hunter | Biotech Hunter