Human Immunodeficiency Virus (HIV-1) Infection Hepatitis B Virus MedDRA version: 20.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.1 Level: PT Classification code 10008910 Term: Chronic hepatitis B System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of B/F/TAF FDC versus a DTG + F/TDF in HIV and HBV treatment naïve, HIV-1 and HBV co-infected subjects as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 48. To evaluate the efficacy of FDC of B/F/TAF versus DTG + F/TDF in HIV and HBV treatment naïve, HIV-1 and HBV co-infected subjects as determined by the proportion of subjects with plasma HBV DNA < 29 IU/mL at Week 48.;Secondary Objective: To evaluate the efficacy of FDC of B/F/TAF versus DTG + F/TDF as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 96. To evaluate the efficacy of FDC of B/F/TAF versus DTG + F/TDF as determined by the proportion of subjects with plasma HBV DNA < 29 IU/mL at Week 96.;Primary end point(s): - The proportion of subjects that have HIV-1 RNA < 50 copies/mL at Week 48 as defined by the US FDA-defined snapshot algorithm - The proportion of subjects with plasma HBV DNA < 29 IU/mL at Week 48 by Missing = Failure approach ;Timepoint(s) of evaluation of this end point: Week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary anti-HIV efficacy endpoints: - The proportion of subjects that have HIV-1 RNA < 50 copies/mL at Week 96 - The change from baseline in CD4 cell count and CD4% at Weeks 48 and 96 Secondary anti-HBV efficacy endpoints: - The proportion of subjects with plasma HBV DNA < 29 IU/mL at Week 96 - The proportion of subjects with ALT normalization at Weeks 48 and 96 - The proportion of subjects with HBsAg loss at Weeks 48 and 96;Timepoint(s) of evaluation of this end point: Weeks 48 and 96 | — |
Countries
Dominican Republic, France, Germany, Greece, Hong Kong, Korea, Republic of, Malaysia, Puerto Rico, Singapore, Spain, Taiwan, Thailand, Turkey, United States
Contacts
Public ContactClinical Trials Mailbox
Gilead Sciences International Ltd.
Outcome results
None listed