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

ConditionHIV Infection
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCristina Mussini

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

30 Participants
are grouped into 1 trial group

Sponsors and collaborators

Cristina Mussini

Lead sponsor

University of Modena and Reggio Emilia

Sponsor institution