Pharmacokinetics, Safety, and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen (STR) in Adolescents

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

December 6, 2012

Primary Completion Date

October 22, 2015

Study Completion Date

January 29, 2018

Conditions
Acquired Immunodeficiency SyndromeHIV Infections
Interventions
DRUG

EVG/COBI/FTC/TDF

150/150/200/300 mg STR administered orally once daily with food

Trial Locations (18)

2013

Perinatal HIV Research Unit, Soweto

2092

Clinical HIV Research Unit, Johannesburg

2112

Rahima Moosa Mother and Child Hospital (Wits), Johannesburg

3000

Mpati Medical Center, Dundee

4001

Dr Latiff Private Practice, Durban

7602

University of Stellenbosch, Stellenbosch

7925

Desmond Tutu HIV Research Centre, Cape Town

10016

New York University School of Medicine, New York

10330

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

10467

Montefiore Medical Center, The Bronx

10700

Siriraj Hospital, Mahidol University, Bangkok

19134

St. Christopher's Hospital for Children, Philadelphia

20110

Queen Savang Vadhana Memorial Hospital, Chon Buri

33606

University of South Florida - Department of Pediatrics, Tampa

38105

St. Jude Children's Research Hospital, Memphis

40002

Srinakarind Hospital, Khon Kaen

60637

University of Chicago, Chicago

94609

East Bay AIDS Center Medical Group, Oakland

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT01721109 - Pharmacokinetics, Safety, and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen (STR) in Adolescents | Biotech Hunter | Biotech Hunter