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Pilot Study to Evaluate Efficacy and Safety of Switching to BIC/FTC/TAF in PWH With a Previous Virological Failure Under CAB/RPV LAI

NCT07620652 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2026-07-07

No results posted yet for this study

Summary

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

Conditions

Sponsors & Collaborators

  • Cristina Mussini

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07620652 on ClinicalTrials.gov