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
Completed · Phase 3 · Has a placebo group
Conditions studied: HIV-1/HBV Co-Infection
In brief
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.
Key facts
- Study ID
- NCT03547908
- Run by
- Gilead Sciences
- People needed
- 244
- Starts
- 2018-05-30
- Expected to finish
- 2024-03-07
- Last updated by the study team
- 2025-03-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Triple O Research Institute, P.A. — West Palm Beach, Florida, United States
- Be Well Medical Center — Berkley, Michigan, United States
- The Crofoot Research Center, INC (DBA: Gordon E. Crofoot MD PA) — Houston, Texas, United States
- Beijing Ditan Hospital Capital Medical University — Beijing, China
- Beijing YouAn Hospital, Capital Medical University — Beijing, China
- Peking Union Medical College Hospital, Chinese Academy of Medical Sciences — Beijing, China
- The First Hospital of Changsha — Changsha, China
- Chengdu Public Health Clinical Center — Chengdu, China
- Guangzhou Eighth people's Hospital — Guangzhou, China
- 1st Affiliated Hospital of Zhejiang University — Hangzhou, China
- The Second Hospital of Nanjing — Nanjing, China
- Shanghai Public Health Clinical Center — Shanghai, China
- Third People's Hospital Of Shenzhen — Shenzhen, China
- Instituto Dominicano de Estudios Virologicos (IDEV) — Santo Domingo, Dominican Republic
- Hôpital de la Croix Rousse — Lyon, France
- Evaggelismos General Hospital of Athens — Athens, Greece
- Korgialenio-Benakio Greek Red Cross General Hospital — Athens, Greece
- Laiko General Hospital — Athens, Greece
- AHEPA University Hospital of Thessaloniki — Thessaloniki, Greece
- 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
- University of the Ryukyus Hospital — Okinawa, Japan
- Midway Immunology & Research — Ft. Pierce, Florida, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.