Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

129

Participants

Timeline

Start Date

May 6, 2013

Primary Completion Date

May 11, 2020

Study Completion Date

June 18, 2025

Conditions
Acquired Immune Deficiency Syndrome (AIDS)HIV Infections
Interventions
DRUG

E/C/F/TAF

Tablets administered orally with food.

DRUG

E/C/F/TAF (Low Dose)

90/90/120/6 mg STR administered once daily orally with food.

Trial Locations (16)

263

University of Zimbabwe - Clinical Research Centre, Belgravia

1862

Perinatal HIV Research Unit Baragwanath Hospital, Johannesburg

2041

Clinical HIV Research Unit, Johannesburg

2092

Empilweni Services and Research Unit (ESRU), Johannesburg

7505

KIDCRU Ward J8, Cape Town

7646

Be Part Yoluntu Centre, Cape Town

7705

Desmond Tutu HIV Foundation, Cape Town

10330

The HIV Netherlands Australia Thailand Research collaboration (HIV-NAT), Bangkok

20010

Children's Research Institute, Washington D.C.

20110

Queen Savang Vadhana Memorial Hospital, Chon Buri

30322

Emory University School of Medicine, Atlanta

38105

St. Jude Children's Research Hospital, Memphis

40002

Department of Pediatrics, Faculty of Medicine, Khon Kaen University, Khon Kaen

90806

Miller's Children Hospital, Long Beach

98105-0371

Seattle Children's Hospital, Seattle

PO Box 10005

Joint Clinical Research Centre, Kampala

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT01854775 - Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children | Biotech Hunter | Biotech Hunter