LAST UPDATED
March 19, 2025
Clinicaltrials.gov ID
EudraCT ID
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 treatment-naïve and HIV-1 and hepatitis B virus (HBV) adults.
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
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
- Human immunodeficiency virus type 1 (HIV-1) co-infection:
- Must be HIV antiretroviral treatment naive with plasma HIV-1 ribonucleic acid (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 hepatitis B virus (HBV) treatment naive (defined as < 12 weeks of oral antiviral treatment)
- Screening HBV deoxyribonucleic acid (DNA) ≥ 2000 IU/mL
- Hepatic transaminases (aspartate aminotransferase (AST) and alanine aminotransferase (ALT)) ≤ 10 x upper limit of normal (ULN)
- Total bilirubin ≤ 2.5 x ULN
Exclusion criteria
- HBV co-infection:
- Must be hepatitis B virus (HBV) treatment naive (defined as < 12 weeks of oral antiviral treatment)
- Screening HBV deoxyribonucleic acid (DNA) ≥ 2000 IU/mL
- Hepatic transaminases (aspartate aminotransferase (AST) and alanine aminotransferase (ALT)) ≤ 10 x upper limit of normal (ULN)
- Total bilirubin ≤ 2.5 x ULN
- Key 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
Ft. Pierce, Florida, United States, 34982
Triple O Research Institute, P.A.
West Palm Beach, Florida, United States, 33401
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
Instituto Dominicano de Estudios Virologicos (IDEV)
Santo Domingo, Dominican Republic, 10103
Korgialenio-Benakio Greek Red Cross General Hospital
Athens, Greece, 11526
AHEPA University Hospital of Thessaloniki
Thessaloniki, Greece, 546 36
National Hospital Organization Nagoya Medical Center
Aichi, Japan, 460-0001
National Hospital Organization Osaka National Hospital
Osaka, Japan, 540-0006
Center Hospital of the National Center for Global Health and Medicine
Tokyo, Japan, 162-8655
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea, 06591
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 80756
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
Faculty of Medicine, Chiang Mai University
Chiang Mai, Thailand, 50200
Bamrasnaradura Infectious Diseases Institute
Nonthaburi, Thailand, 11000
Istanbul University Cerrahpasa Medical Faculty
Istanbul, Turkey (Türkiye), 34098
Marmara University Pendik Training and Research Hospital
Istanbul, Turkey (Türkiye), 81190
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