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 (BICPREVIR)

May 26, 2026 updated by: Cristina Mussini

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

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

BIC/FTC/TAF has been studied in treatment-naïve and virologically suppressed people with HIV (PWH) with a cumulative exposure of >3.1 million person-years of treatment.

Cabotegravir/Rilpivirine (CAB/RPV) is the first long-acting injectable (LAI) regimen approved and could be a game-changer in the world of HIV treatment, as it is the first ever HIV drug combination that does not need to be taken every day. However, although data from randomized clinical trials demonstrated the non-inferiority efficacy of CAB/RPV LAI in PWH switching from triple therapies, a higher rate of emergent resistance associated mutations (RAMs) to INSTI and NNRTIs emerged. The risk of acquired RAMs may be even higher in clinical practice, outside the controlled conditions of clinical trials. Although the rate of virological failure is quite rare (1%-2%), resistance to these types of drugs (especially INSTI) is a major problem for PWH, as it severely limits the future treatment options. In the light of these considerations, it becomes important to understand if the reduced susceptibility is really relevant in clinical practice, identifying the remaining treatment options; are PIs the only possible choice or is there still room for INSTIs? In this sense, bictegravir has the longest dissociation time from the target among INSTIs (retaining its inhibitory activity against HIV replication for a longer time) and showed an improved resistance profile compared with other INSTIs, including DTG, in vitro. Moreover, a recent in vitro phenotype assessment of isolates with a CAB failure-like patterns of RAMs showed that 54% and 40% of the isolates maintained susceptibility or partial susceptibility to bictegravir, respectively.

Finally, it is currently unknown if INSTI mutations will persist on DNA or if they will disappear.

This study is a pilot, multi-center, observational retrospective-prospective study, that will include 30 subjects failing CAB/RPV LAI. The primary objective is to describe drug efficacy at week 24. Secondary objectives are to describe drug efficacy at week 48, to describe drug failure at week 24 and week 48, to describe immunological changes at week 24 and week 48, to describe drug safety and to describe changes in patient's quality of life.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

30 subjects failing CAB/RPV LAI will be included in the study

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
subjects failing CAB/RPV LAI switching to BIC/FTC/TAF per clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of virological suppression (proportion of PWH with HIV-RNA <50 copies/mL) at week 24 (after the switch to BIC/FTC/TAF)
Time Frame: From enrollment to week 24
From enrollment to week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of virological suppression (proportion of PWH with HIV-RNA <50 copies/mL) at week 48
Time Frame: From enrollment to week 48
From enrollment to week 48
Rate of virologic failure (2 consecutive VL ≥50 copies/mL) at weeks 24 and 48
Time Frame: From enrollment to week 48
From enrollment to week 48
Change from baseline in CD4+ T-cell count (absolute and %) and CD4/CD8 ratio at weeks 24 and 48
Time Frame: From enrollment to week 48
From enrollment to week 48
WHO grade 3-4 toxicity
Time Frame: From enrollment to week 48
From enrollment to week 48
Rate of discontinuation of BIC/FTC/TAF for AEs
Time Frame: From enrollment to week 48
From enrollment to week 48
Change in treatment satisfaction after the switch to BIC/FTC/TAF (changes in HIVTSQ)
Time Frame: From enrollment to week 48
From enrollment to week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cristina Mussini

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

May 26, 2026

First Submitted That Met QC Criteria

May 26, 2026

First Posted (Actual)

June 2, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BICPREVIR
  • 2573 (Registry Identifier: Registro Studi Osservazionali)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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