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
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
None
30 subjects failing CAB/RPV LAI will be included in the study
Other
Other
Not listed
Rate of virological suppression (proportion of PWH with HIV-RNA <50 copies/mL) at week 24 (after the switch to BIC/FTC/TAF)
Rate of virological suppression (proportion of PWH with HIV-RNA <50 copies/mL) at week 48
Rate of virologic failure (2 consecutive VL ≥50 copies/mL) at weeks 24 and 48
Change from baseline in CD4+ T-cell count (absolute and %) and CD4/CD8 ratio at weeks 24 and 48
WHO grade 3-4 toxicity
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Cristina Mussini
Lead sponsor
University of Modena and Reggio Emilia
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
