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COMPLETED 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

NCT03547908 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 244 participants
Start Date 2018-05-30
Est. Completion 2024-03-07
Phase Phase 3

Sponsor

Gilead Sciences

190 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 190 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03547908 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Other, Florida, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03547908?

This trial is sponsored by Gilead Sciences, which has 190 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial