B-free Multistage Trial

The primary objective of the study is to evaluate the efficacy of a booster-free regimen including DOR/DTG/3TC among HIV-suppressed PLWH with previous virological failure. The key secondary objectives are i) to determine whether switching to DOR / DTG / 3TC leads to lower burden of DDI compared to continuing a booster-containing regimen, and ii) to assess changes in patient perception on treatment acceptability and satisfaction, as well as health-related quality of life after a switch to booster-free ART. Qualitative sub-study: Qualitative objectives will be met using semi-structured interviews. Thirty people (15 from the intervention arm, 15 from the control arm) will be interviewed twice, at week 0 and week 48. Additional 15 individuals from the observational cohort will be interviewed once. Interviews will take place following study visits and performed using semi-structured guides. The guide for the interviews at week 48 will be based on results from analyses of the interviews conducted at week 0.

NCT Number	NCT06037564
Lead Sponsor	Insel Gruppe AG, University Hospital Bern Collaborators: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland, University of Bern
Conditions	HIV, Drug Resistance, Drug Drug Interaction
Enrollment	210 participants
Start Date	2023-11-13
Primary Completion	2026-10 (estimated)
Study Completion	2027-09 (estimated)
Updated on ClinicalTrials.gov	2024-12-04