NCT02285114View on ClinicalTrials.gov

Study To Evaluate Emtricitabine/Tenofovir Alafenamide (F/TAF) in Human Immunodeficiency Virus 1 (HIV-1) Infected Children and Adolescents Virologically Suppressed on a 2-Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (2-NRTI)-Containing Regimen

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

January 20, 2015

Primary Completion Date

November 4, 2019

Study Completion Date

December 11, 2024

Conditions
HIV-1
Interventions
DRUG

F/TAF

F/TAF tablets administered orally once daily

DRUG

3rd ARV agent

A 3rd antiretroviral (ARV) agent may include one of the following: allowed boosted 3rd ARV agents: lopinavir (LPV), atazanavir (ATV), darunavir (DRV); Allowed unboosted 3rd ARV agents: efavirenz (EFV), raltegravir (RAL), dolutegravir (DTG), or nevirapine (NVP)

DRUG

Boosted PIs

Allowed boosted PIs: LPV, ATV, DRV.

Trial Locations (8)

2093

Rahima Moosa Mother and Child Hospital, Johannesburg

7505

KIDCRU, Ward J8, Tygerberg Children's Hospital, Cape Town

7626

Be Part Yoluntu Centre, Cape Town

19134

St. Christopher's Hospital for Children, Philadelphia

80045

Children's Hospital Colorado, Aurora

90095

University of California Los Angeles, Los Angeles

98105-0371

Seattle Children's Hospital, Seattle

0816-00383

Hospital del Nino, Panama City

Sponsors

Lead Sponsor

Gilead Sciences
All Listed Sponsors
lead

Gilead Sciences

INDUSTRY