Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults

PHASE3CompletedINTERVENTIONAL
Enrollment

244

Participants

Timeline

Start Date

May 30, 2018

Primary Completion Date

February 25, 2022

Study Completion Date

March 7, 2024

Conditions
HIV-1/HBV Co-Infection
Interventions
DRUG

B/F/TAF

50/200/25 mg B/F/TAF FDC tablet administered orally once daily, without regard to food

DRUG

Placebo to match DTG

Tablet administered orally once daily, without regard to food

DRUG

Placebo to match F/TDF

Tablet administered orally once daily, without regard to food

DRUG

DTG

50 mg tablet administered orally once daily, without regard to food

DRUG

F/TDF

200/300 mg tablet administered orally once daily, without regard to food

DRUG

Placebo to match B/F/TAF

Tablet administered orally once daily, without regard to food

Trial Locations (69)

10048

National Taiwan University Hospital, Taipei

10103

Instituto Dominicano de Estudios Virologicos (IDEV), Santo Domingo

10330

Thai Red Cross AIDS Research Centre (HIV-NAT), Bangkok

10400

Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok

10450

Hospital Pulau Pinang, Pulau Pinang

10676

Evaggelismos General Hospital of Athens, Athens

10700

Siriraj Hospital, Bangkok

10844

Taipei City Hospital Linsen, Chinese Medicine and Kunming Branch, Taipei

11000

Bamrasnaradura Infectious Diseases Institute, Nonthaburi

11217

Taipei Veterans General Hospital, Taipei

11526

Korgialenio-Benakio Greek Red Cross General Hospital, Athens

11527

Laiko General Hospital, Athens

15580

Hospital Raja Perempuan Zainab II, Kota Bharu

20400

Hospital Sultanah Nur Zahirah, Kuala Terengganu

22060

Far Eastern Memorial Hospital, New Taipei City

28040

Fundacion Jimenez Diaz, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital Universitario La Paz, Madrid

31350

Hospital Raja Permaisuri Bainun, Ipoh

33004

Ministry of Health and Welfare Taoyuan General Hospital, Taoyuan

33401

Triple O Research Institute, P.A., West Palm Beach

34098

Istanbul University Cerrahpasa Medical Faculty, Istanbul

34982

Midway Immunology & Research, Ft. Pierce

36312

CHUVI - Hospital Universitario Alvaro Cunqueiro, Vigo

38320

Hospital de Canarias, Santa Cruz de Tenerife

40002

Srinagarind Hospital, Khon Kaen

40705

Taichung Veterans General Hospital, Taichung

46014

Hospital General Universitario de Valencia, Valencia

47000

Sungai Buloh Hospital, Sungai Buloh

48072

Be Well Medical Center, Berkley

49241

Pusan National University Hospital, Busan

50200

Faculty of Medicine, Chiang Mai University, Chiang Mai

50603

University Malaya Medical Centre, Kuala Lumpur

53000

Hospital Kuala Lumpur, Kuala Lumpur

57000

Chiang Rai Reginal Hospital, Chiang Rai

69004

Hôpital de la Croix Rousse, Lyon

70403

National Cheng Kung University Hospital, Tainan City

77098

The Crofoot Research Center, INC (DBA: Gordon E. Crofoot MD PA), Houston

80756

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

81190

Marmara University Pendik Training and Research Hospital, Istanbul

81362

Kaohsiung Veterans General Hospital, Kaohsiung City

88200

Queen Elizabeth Hospital, Kota Kinabalu

93586

Sarawak General Hospital, Kuching

100015

Beijing Ditan Hospital Capital Medical University, Beijing

100069

Beijing YouAn Hospital, Capital Medical University, Beijing

100730

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing

201058

Shanghai Public Health Clinical Center, Shanghai

410005

The First Hospital of Changsha, Changsha

510060

Guangzhou Eighth people's Hospital, Guangzhou

518040

Third People's Hospital Of Shenzhen, Shenzhen

610066

Chengdu Public Health Clinical Center, Chengdu

Unknown

1st Affiliated Hospital of Zhejiang University, Hangzhou

The Second Hospital of Nanjing, Nanjing

Prince of Wales Hospital, Hong Kong

Queen Elizabeth Hospital (QEH), Hong Kong

Princess Margaret Hospital, Kowloon

Hospital General Universitario Santa Lucia, Cartagena

546 36

AHEPA University Hospital of Thessaloniki, Thessaloniki

460-0001

National Hospital Organization Nagoya Medical Center, Aichi

903-0215

University of the Ryukyus Hospital, Okinawa

534-0021

Osaka City General Hospital, Osaka

540-0006

National Hospital Organization Osaka National Hospital, Osaka

105-8471

The Jikei University Hospital, Tokyo

113-8431

Juntendo University Hospital, Tokyo

162-8655

Center Hospital of the National Center for Global Health and Medicine, Tokyo

236-0004

Yokohama City University Hospital, Yokohama

00909

Hope Clinical Research, San Juan

06591

The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul

08036

Hospital Clinic de Barcelona, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY