AzTrials
AzTrials

HIV InfectionBICPREVIRNCT07620652

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

An observational study of HIV Infection, run by Cristina Mussini at 1 site in Italy.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infection
How many people
30 participants
Where
1 siteItaly
Study dates
Jul 2026to 30 Jun 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Cristina Mussini, Full Professor, MD contact

+390594222466

cristina.mussini@unimore.it

Italy1 site

  • AOU Modena

    Modena, MO, 41124

    Cristina Mussini, MD, +390594222466, cristina.mussini@unimore.it

Other trials in Italy

About this study

Official title: 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
Read more

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

Read the 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.

Conditions
HIV Infection
Keywords
HIV, Long acting ART, Therapeutic switch
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07620652
Study groupRoleWhat they receive
1subjects failing CAB/RPV LAI switching to BIC/FTC/TAF per clinical practice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of virological suppression (proportion of PWH with HIV-RNA <50 copies/mL) at week 24 (after the switch to BIC/FTC/TAF)

    Measured: From enrollment to week 24

Secondary outcomes (6)

  1. Rate of virological suppression (proportion of PWH with HIV-RNA <50 copies/mL) at week 48

    Measured: From enrollment to week 48

  2. Rate of virologic failure (2 consecutive VL ≥50 copies/mL) at weeks 24 and 48

    Measured: From enrollment to week 48

  3. Change from baseline in CD4+ T-cell count (absolute and %) and CD4/CD8 ratio at weeks 24 and 48

    Measured: From enrollment to week 48

  4. WHO grade 3-4 toxicity

    Measured: From enrollment to week 48

  5. Rate of discontinuation of BIC/FTC/TAF for AEs

    Measured: From enrollment to week 48

  6. Change in treatment satisfaction after the switch to BIC/FTC/TAF (changes in HIVTSQ)

    Measured: From enrollment to week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2026
  2. Study startJul 2026 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07620652
Sponsor's protocol ID
BICPREVIR
Other IDs
2573
Acronym
BICPREVIR
Status last verified
May 2026
First submitted
26 May 2026
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jongen VW, Wit FWNM, Boyd A, van Eeden A, Brouwer AE, Soetekouw R, El Moussaoui R, Stalenhoef J, Sigaloff KCE, Mudrikova T, Gisolf J, Burger D, Wensing AMJ, van der Valk M; ATHENA National Observational HIV Cohort. Effectiveness of bi-monthly long-acting injectable cabotegravir and rilpivirine as maintenance treatment for HIV-1 in the Netherlands: results from the Dutch ATHENA national observational cohort. Lancet HIV. 2025 Jan;12(1):e40-e50. doi: 10.1016/S2352-3018(24)00269-8.

    PubMed 39779044

  • Iannone V, Lombardi F, Ciccullo A, Lamanna F, Salvo PF, Sanfilippo A, Baldin G, Borghetti A, Torti C, Di Giambenedetto S. Real World Data from an Italian Outpatient Clinical Setting and from Home Care Assistance of Treatment-Experienced PWH Switching to CAB + RPV Regimen: A Prospective Observational Study. AIDS Behav. 2025 Apr;29(4):1228-1234. doi: 10.1007/s10461-024-04597-4. Epub 2025 Jan 9.

    PubMed 39779624

  • Mchantaf G, Chaillon A, Charre C, Melard A, Gardiennet E, Guinard J, Prazuck T, Guillaume C, Mariaggi AA, Bois J, Hocqueloux L, Avettand-Fenoel V. Learning From Full Characterization of HIV Proviruses in People Receiving Long-Acting Cabotegravir/Rilpivirine With a History of Replication on the Antiretroviral Classes. Open Forum Infect Dis. 2024 Dec 24;12(1):ofae748. doi: 10.1093/ofid/ofae748. eCollection 2025 Jan.

    PubMed 39872809

  • McCall KL, Cabral DL, Coghlan JF, Concepcion AM, Denimarck KE, Shalumov SS. Therapeutic failure reported with HIV long-acting injectables: An analysis of the FDA Adverse Event Reporting System from 2021 to 2024. HIV Med. 2025 Jan;26(1):173-178. doi: 10.1111/hiv.13709. Epub 2024 Sep 5.

    PubMed 39234659

  • Perez Navarro A, Nutt CT, Siedner MJ, McCluskey SM, Hill A. Virologic Failure and Emergent Integrase Strand Transfer Inhibitor Drug Resistance With Long-Acting Cabotegravir for HIV Treatment: A Meta-analysis. Clin Infect Dis. 2025 Sep 16;81(2):274-285. doi: 10.1093/cid/ciae631.

    PubMed 39724249

  • Cutrell AG, Schapiro JM, Perno CF, Kuritzkes DR, Quercia R, Patel P, Polli JW, Dorey D, Wang Y, Wu S, Van Eygen V, Crauwels H, Ford SL, Baker M, Talarico CL, Clair MS, Jeffrey J, White CT, Vanveggel S, Vandermeulen K, Margolis DA, Aboud M, Spreen WR, van Lunzen J. Exploring predictors of HIV-1 virologic failure to long-acting cabotegravir and rilpivirine: a multivariable analysis. AIDS. 2021 Jul 15;35(9):1333-1342. doi: 10.1097/QAD.0000000000002883.

    PubMed 33730748

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infection, run by Cristina Mussini at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cristina Mussini, Full Professor, MD (+390594222466, cristina.mussini@unimore.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07620652, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in