Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study of HIV-1/HBV Co-Infection, sponsored by Gilead Sciences.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Percentages were rounded-off.
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 |
What the finished NCT03547908 record still lists
NCT03547908 is an interventional study that assigns participants to a tested intervention. The registered 244 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower).
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 names 20 study sites across 4 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03547908's enrollment target sits among peer trials
244 1269th of 2000 higher than 732 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02227251 · 244 participants · Phase 2
Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
- NCT04317534 · 244 participants · Phase 2
Adjuvant Pembrolizumab vs Observation Following Curative Resection for Stage I Non-small Cell Lung Cancer (NSCLC) With Primary Tumors Between 1-4 cm
- NCT04683250 · 244 participants · Phase 1
Study of RET Inhibitor TAS0953/HM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities
- NCT04686305 · 244 participants · Phase 1
Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous NSCLC
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI