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Switching to bictegravir, emtricitabine and tenofovir alafenamide after HIV treatment failed on injections

Follows adults with HIV who switch pills after cabotegravir and rilpivirine injections failed.

Plain-language title generated from the registry record
Registry title: 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, ItalySee the site

Where in Italy

  • AOU ModenaModena, ItalyNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Cristina Mussini
Trial code
NCT07620652
Record updated
7 July 2026
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.

ClinicalTrials.gov NCT07620652