This study will test a United States Food and Drug Administration (FDA) approved drug named bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) fixed dose combination (FDC) for the treatment of HIV-1. This drug has been approved as Biktarvy® in the United States in February 2018. The purpose of this study is to test the effectiveness of B/F/TAF FDC against HIV-1 and Hepatitis B in subjects not currently receiving treatment for their HIV-1 and HBV infection, compared to DTG + F/TDF.

Phase 1

• Conditions: Human Immunodeficiency Virus (HIV-1) InfectionHepatitis B Virus; MedDRA version: 20.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.1Level: PTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2018-000926-79-FR
• Lead Sponsor: Gilead Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-13
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.

1) The ability to understand and sign a written informed consent form, which must be obtained
prior to initiation of study procedures
2) Aged 18 years or above
3) HIV-1 co-infection
4) HBV co-infection
5) Normal ECG (or if abnormal, determined by the investigator not to be clinically significant)
6) Estimated glomerular filtration rate (eGFR) greater than or equal to 50 mL/min according to the Cockcroft-Gault
(C-G) formula
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 240
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Hepatitis C Virus (HCV) antibody positive and HCV RNA detectable
2) Previous use of any approved or experimental HIV integrase inhibitor
3) Subjects experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding) or with Child-Pugh-Turcotte (CPT) C impairment
4) Subjects receiving ongoing therapy with any of the disallowed agents listed in the protocol, including drugs not to be used with FTC, TAF, TDF, bictegravir and DTG
5) Acute hepatitis in the 30 days prior to study entry
6) Active tuberculosis infection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified