Ph 3b, BIC/FTC/TAF to DTG/3TC FDC, 96 Week switch, efficacy, safety study in older HIV patients
Research type
Research Study
Full title
A Phase 3b, multicenter, single-arm, open-label study evaluating the efficacy, safety, and tolerability of switching to DTG/3TC single tablet regimen administered once daily from a bictegravir/emtricitabine/tenofovir alafenamide single tablet regimen in people living with HIV of at least 50 years of age who are virologically suppressed
IRAS ID
1007832
Contact name
Karen Grainger
Contact email
Sponsor organisation
Viiv Healthcare UK Limited
Clinicaltrials.gov Identifier
Research summary
Participants in this study will be PLHIV that have previously taken antiretroviral therapy. Participants must have been on Biktarvy for at least 6 months prior to Screening and have an undetectable viral load at Screening. All eligible participants that are enrolled will switch to DTG/3TC at Day 1 and will be followed up for 96 weeks.
Participants will continue in the study for about 2 years and will have regular medical tests and assessments performed (including blood tests, questionnaires, and interviews).
Participants who complete the study at Week 96 will transition off study to locally accessible Dovato, or to alternative local standard-of-care HIV treatment as agreed between the participant and the study doctor.
REC name
London - City & East Research Ethics Committee
REC reference
23/LO/0694
Date of REC Opinion
19 Sep 2023
REC opinion
Further Information Favourable Opinion