NCT02881320 - Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1 | Biotech Hunter

Enrollment

177

Participants

Timeline

Start Date

September 21, 2016

Primary Completion Date

March 24, 2025

Study Completion Date

November 30, 2026

Conditions

HIV-1 Infection

Interventions

DRUG

B/F/TAF (Adult Strength)

50/200/25 mg FDC tablets administered orally once daily without regard to food.

DRUG

B/F/TAF (Low Dose)

30/120/15 mg FDC tablets administered orally once daily without regard to food.

DRUG

B/F/TAF (TOS)

2 x B/F/TAF 15/60/7.5 mg (total daily dose 30/120/15 mg) FDC tablets administered orally as TOS, once daily.

DRUG

B/F/TAF (TOS)

2 x B/F/TAF 3.75/15/1.88 mg (total daily dose 15/60/7.52 mg) FDC tablets administered orally as TOS, twice daily.

DRUG

B/F/TAF (TOS)

1 x B/F/TAF 3.75/15/1.88 mg (total daily dose 7.5/30/3.76 mg) FDC tablets administered orally as TOS, twice daily.

DRUG

B/F/TAF (TOS)

1 x B/F/TAF 1.88/7.5/0.94 mg (total daily dose 3.76/15/1.88 mg) FDC tablets administered orally as TOS, twice daily

Trial Locations (25)

2013

Perinatal HIV Research Unit, Soweto

2038

Wits RHI Shandukani Research Centre, Wits Reproductive Health & HIV Institute, Johannesburg

2112

Empilweni Service and Research Unit (ESRU), Johannesburg

3000

Dr. J Fourie Medical Centre, Dundee

4302

Enhancing Care Foundation, Durban International Clinical Research Site, Durban

7505

FAMCRU, Ward J8, CapeTown

7646

Be Part Ypluntu Centre, Cape Town

9301

Department of Paediatrics and Child Health, Bloemfontein

10005

Joint Clinical Research Centre, Kampala

10016

Bellevue Hospital, New York

10330

The HIV Netherlands Australia Thailand Research Collaboration, Bangkok

10700

Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok

19134

St. Christopher's Hospital for Children/Section of Immunology, Philadelphia

20010

Children's National Health System, Washington D.C.

27710

Duke Children's Health Center, Pediatric Infectious Diseases, Durham

30322

Grady Health System Ponce Center Family and Youth Clinic, Atlanta

32209

University of Florida Health, Gainesville

33606

USF Clinic at Children's Medical Services (study visits and drug storage), Tampa

34982

Midway Immunology and Research Center, Ft. Pierce

38105

St. Jude Children's Research Hospital, Memphis

40002

Faculty of Medicine, Khon Kaen University, Khon Kaen

48201

Wayne Pediatric Clinic, Detroit

0087

VX Pharma(Pty) Ltd, Pretoria

0000

Makerere University, Johns Hopkins (MU-JHU) Research Collaboration, Kampala

Unknown

Baylor College of Medicine Children's Foundation - Uganda, Kampala