Study Details

OVERVIEW

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naïve, HIV-1 and Hepatitis B Co-Infected Adults (Alliance)

PROTOCOL SUMMARY

The primary objective of this study is to evaluate the efficacy of fixed-dose combination (FDC) of bictegravir/emtricitabine/ tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + emtricitabine/tenofovir disoproxil fumarate (F/TDF) in HIV and hepatitis B virus (HBV) treatment naive, HIV-1 and HBV co-infected adults.

Participation Requirements

Age

18 Years +

Sex

All

Healthy Volunteers

Medical Condition

HIV-1/HBV Co-Infection

Gender

N/A

Date

May 2018 - February 2022

Study Type

Interventional

Study Phase

Phase 3

Product

B/F/TAF, Placebo to match DTG, Placebo to match F/TDF, DTG, F/TDF, Placebo to match B/F/TAF

Eligibility Information

Inclusion Criteria

HIV-1 co-infection:
Must be HIV antiretroviral treatment naive with plasma HIV-1 RNA ≥ 500 copies/mL at screening
≤ 10 days of prior therapy with any antiretroviral agent, including lamivudine and entecavir, following a diagnosis of HIV-1 infection (except the use for pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to screening)
Screening genotype report must show sensitivity to emtricitabine (FTC) and tenofovir (TFV). This report will be provided by Gilead Sciences. Alternatively, if genotype results from a local laboratory obtained ≤ 90 days prior to screening visit date show sensitivity to these drugs, this genotype will be acceptable to fulfill this inclusion criterion in the event that the genotype obtained at screening is not yet available and all other inclusion/exclusion criteria have been confirmed
HBV co-infection:
Must be HBV treatment naive (defined as < 12 weeks of oral antiviral treatment)
Screening HBV DNA ≥ 2000 IU/mL
Hepatic transaminases (aspartate aminotransferase (AST) and ALT) ≤ 10 x upper limit of normal (ULN)
Total bilirubin ≤ 2.5 x ULN

Exclusion Criteria

Hepatitis C virus (HCV) antibody positive and HCV RNA detectable
Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding) or with Child-Pugh-Turcotte (CPT) C impairment
Current alcohol or substance use judged by the Investigator to potentially interfere with study compliance
Active, serious infections (other than HIV-1 and HBV infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1
Participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trial
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

Locations (69)

Midway Immunology & Research

Fort Pierce, Florida, United States, 34982

Triple O Research Institute, P.A.

West Palm Beach, Florida, United States, 33401

Be Well Medical Center

Berkley, Michigan, United States, 48072

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

Houston, Texas, United States, 77098

Beijing Ditan Hospital Capital Medical University

Beijing, China, 100015

Beijing YouAn Hospital, Capital Medical University

Beijing, China, 100069

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, China, 100730

The First Hospital of Changsha

Changsha, China, 410005

Chengdu Public Health Clinical Center

Chengdu, China, 610066

Guangzhou Eighth people's Hospital

Guangzhou, China, 510060

1st Affiliated Hospital of Zhejiang University

Hangzhou, China

The Second Hospital of Nanjing

Nanjing, China

Shanghai Public Health Clinical Center

Shanghai, China, 201058

Third People's Hospital Of Shenzhen

Shenzhen, China, 518040

Instituto Dominicano de Estudios Virologicos (IDEV)

Santo Domingo, Dominican Republic, 10103

Hôpital de la Croix Rousse

Lyon, France, 69004

Evaggelismos General Hospital of Athens

Athens, Greece, 10676

Korgialenio-Benakio Greek Red Cross General Hospital

Athens, Greece, 11526

Laiko General Hospital

Athens, Greece, 11527

AHEPA University Hospital of Thessaloniki

Thessaloniki, Greece, 546 36

Prince of Wales Hospital

Hong Kong, Hong Kong

Queen Elizabeth Hospital (QEH)

Hong Kong, Hong Kong

Princess Margaret Hospital

Kowloon, Hong Kong

National Hospital Organization Nagoya Medical Center

Aichi, Japan, 460-0001

University of the Ryukyus Hospital

Okinawa, Japan, 903-0215

Osaka City General Hospital

Osaka, Japan, 534-0021

National Hospital Organization Osaka National Hospital

Osaka, Japan, 540-0006

The Jikei University Hospital

Tokyo, Japan, 105-8471

Juntendo University Hospital

Tokyo, Japan, 113-8431

Center Hospital of the National Center for Global Health and Medicine

Tokyo, Japan, 162-8655

Yokohama City University Hospital

Yokohama, Japan, 236-0004

Pusan National University Hospital

Busan, Korea, Republic of, 49241

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

Seoul, Korea, Republic of, 06591

Hospital Raja Permaisuri Bainun

Ipoh, Malaysia, 31350

Hospital Raja Perempuan Zainab II

Kota Bahru, Malaysia, 15580

Queen Elizabeth Hospital

Kota Kinabalu, Malaysia, 88200

University Malaya Medical Centre

Kuala Lumpur, Malaysia, 50603

Hospital Kuala Lumpur

Kuala Lumpur, Malaysia, 53000

Hospital Sultanah Nur Zahirah

Kuala Terengganu, Malaysia, 20400

Sarawak General Hospital

Kuching, Malaysia, 93586

Hospital Pulau Pinang

Pulau Pinang, Malaysia, 10450

Sungai Buloh Hospital

Sungai Buloh, Malaysia, 47000

Hope Clinical Research

San Juan, Puerto Rico, 00909

Hospital Clinic de Barcelona

Barcelona, Spain, 08036

Hospital General Universitario Santa Lucia

Cartagena, Spain

Fundacion Jimenez Diaz

Madrid, Spain, 28040

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Hospital Universitario La Paz

Madrid, Spain, 28046

Hospital de Canarias

Santa Cruz de Tenerife, Spain, 38320

Hospital General Universitario de Valencia

Valencia, Spain, 46014

CHUVI - Hospital Universitario Alvaro Cunqueiro

Vigo, Spain, 36312

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, Taiwan, 80756

Kaohsiung Veterans General Hospital

Kaohsiung, Taiwan, 81362

Far Eastern Memorial Hospital

New Taipei City, Taiwan, 22060

Taichung Veterans General Hospital

Taichung, Taiwan, 40705

National Cheng Kung University Hospital

Tainan, Taiwan, 70403

Taipei Veterans General Hospital

Taipei City, Taiwan, 11217

National Taiwan University Hospital

Taipei, Taiwan, 10048

Taipei City Hospital Linsen, Chinese Medicine and Kunming Branch

Taipei, Taiwan, 10844

Ministry of Health and Welfare Taoyuan General Hospital

Taoyuan City, Taiwan, 33004

Thai Red Cross AIDS Research Centre (HIV-NAT)

Bangkok, Thailand, 10330

Faculty of Medicine Ramathibodi Hospital, Mahidol University

Bangkok, Thailand, 10400

Siriraj Hospital

Bangkok, Thailand, 10700

Faculty of Medicine, Chiang Mai University

Chiang Mai, Thailand, 50200

Chiang Rai Reginal Hospital

Chiang Rai, Thailand, 57000

Srinagarind Hospital

Khon Kaen, Thailand, 40002

Bamrasnaradura Infectious Diseases Institute

Nonthaburi, Thailand, 11000

Istanbul University Cerrahpasa Medical Faculty

Istanbul, Turkey, 34098

Marmara University Pendik Training and Research Hospital

Istanbul, Turkey, 81190

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 (Alliance)