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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2025-03-19

Study results available
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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

  • HIV-1/HBV Co-Infection

Interventions

DRUG

B/F/TAF

50/200/25 mg B/F/TAF FDC tablet administered orally once daily, without regard to food

DRUG

Placebo to match DTG

Tablet administered orally once daily, without regard to food

DRUG

Placebo to match F/TDF

Tablet administered orally once daily, without regard to food

DRUG

DTG

50 mg tablet administered orally once daily, without regard to food

DRUG

F/TDF

200/300 mg tablet administered orally once daily, without regard to food

DRUG

Placebo to match B/F/TAF

Tablet administered orally once daily, without regard to food

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-30
Primary Completion
2022-02-25
Completion
2024-03-07
FDA Drug
Yes

Countries

  • United States
  • China
  • Dominican Republic
  • France
  • Greece
  • Hong Kong
  • Japan
  • Malaysia
  • Puerto Rico
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03547908 on ClinicalTrials.gov