Pilot Study to Evaluate Efficacy and Safety of Switching to BIC/FTC/TAF in PWH With a Previous Virological Failure Under CAB/RPV LAI
Key facts
- Where
- Modena, OlaszországSee the site
Where in Olaszország
- AOU ModenaModena, OlaszországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Cristina Mussini
- Trial code
- NCT07620652
- Record updated
- 2026. július 7.
- Original description
This study is a pilot, multi-center, observational retrospective-prospective study, with two different Parts, as follows:Read full original descriptionShow less
Retrospective/Prospective Pilot Study to Evaluate Efficacy and Safety of Switching to BIC/FTC/TAF in PWH With a Previous Virological Failure Under CAB/RPV LAI
This study is a pilot, multi-center, observational retrospective-prospective study, with two different Parts, as follows:
1. Part 1(retrospective and prospective part): to evaluate efficacy and safety of switching to BIC/FTC/TAF in People living with HIV (PWH) who previously failed CAB/RPV LAI in the last three years and received in the last three years boosted PI since any INSTI mutations were detected on RNA and/or DNA through NGS at failure 2. Part 2 (prospective part only): to evaluate efficacy and safety of switching directly to BIC/FTC/TAF in PWH who failed CAB/RPV LAI without any RAMs on RNA and/or DNA through NGS considered of potential relevance for bictegravir
Inclusion Criteria:
* PWH with age >18 years * PWH with a confirmed virological failure on CAB/RPV LAI in the last three years * PWH without RAMs versus FTC and TAF
Study population: 30 subjects failing CAB/RPV LAI will be included in the study
Inclusion: PWH with age >18 years; PWH with a confirmed virological failure on CAB/RPV LAI in the last three years; PWH without RAMs versus FTC and TAF.