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NCT03547908 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of HIV-1/HBV Co-Infection, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 244
- Enrollment target
- 20
- Study locations
NCT03547908 is a Phase 3 study of HIV-1/HBV Co-Infection that has completed, run by Gilead Sciences. The registered enrollment target is 244 participants. The trial reports 20 study locations across 4 states.
The verdict
NCT03547908, a Phase 3 study of HIV-1/HBV Co-Infection, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 244 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG B/F/TAF
- DRUG F/TDF
- DRUG Placebo to match DTG
- DRUG Placebo to match F/TDF
- DRUG DTG
Study Locations (20)
Other
- Beijing Ditan Hospital Capital Medical University - Beijing
- Beijing YouAn Hospital, Capital Medical University - Beijing
- Peking Union Medical College Hospital, Chinese Academy of Medical Sciences - Beijing
- The First Hospital of Changsha - Changsha
- Chengdu Public Health Clinical Center - Chengdu
- Guangzhou Eighth people's Hospital - Guangzhou
- 1st Affiliated Hospital of Zhejiang University - Hangzhou
- The Second Hospital of Nanjing - Nanjing
- Shanghai Public Health Clinical Center - Shanghai
- Third People's Hospital Of Shenzhen - Shenzhen
- Instituto Dominicano de Estudios Virologicos (IDEV) - Santo Domingo
- Hôpital de la Croix Rousse - Lyon
- Evaggelismos General Hospital of Athens - Athens
- Korgialenio-Benakio Greek Red Cross General Hospital - Athens
- Laiko General Hospital - Athens
- AHEPA University Hospital of Thessaloniki - Thessaloniki
Florida
- Midway Immunology & Research - Ft. Pierce
- Triple O Research Institute, P.A. - West Palm Beach
Michigan
- Be Well Medical Center - Berkley
Texas
- The Crofoot Research Center, INC (DBA: Gordon E. Crofoot MD PA) - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 244 participants |
| Start Date | 2018-05-30 |
| Est. Completion | 2024-03-07 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03547908
The ClinicalTrials.gov registry entry for NCT03547908 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 244 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with HIV-1/HBV Co-Infection appearing as the primary indexed condition, and to 5 interventions - of which B/F/TAF is the first listed.
NCT03547908 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Other, Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT03547908 about?
NCT03547908 is a clinical study titled "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". 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) adult...
What is the current status of trial NCT03547908?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 244 participants. The study started on 2018-05-30. Estimated completion is 2024-03-07.
What conditions does trial NCT03547908 study?
This clinical trial studies the following conditions: HIV-1/HBV Co-Infection.
What interventions are being tested in trial NCT03547908?
The interventions under investigation include: B/F/TAF (DRUG), F/TDF (DRUG), Placebo to match DTG (DRUG), Placebo to match F/TDF (DRUG), DTG (DRUG).
Who is sponsoring clinical trial NCT03547908?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03547908 being conducted?
This trial has 20 study locations across Florida, Michigan, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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