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

NCT07620652 | Not Yet Recruiting

• 2 other identifiers: BICPREVIR2573
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a pilot, multi-center, observational retrospective-prospective study, with two different Parts, as follows:

• 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

HIV Infection

Keywords

HIV; Long acting ART; Therapeutic switch

Outcome Measures

Primary Outcomes (1)

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

  From enrollment to week 24

Secondary Outcomes (6)

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

  From enrollment to week 48

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

  From enrollment to week 48

• WHO grade 3-4 toxicity

  From enrollment to week 48

• Rate of discontinuation of BIC/FTC/TAF for AEs

  From enrollment to week 48

Study Arms (1)

1

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

Sponsors & Collaborators

• Cristina Mussini: lead

Study Sites (1)

AOU Modena

Modena, MO, 41124, Italy

Location

Related Publications (6)

• 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.

  PMID: 39779044 BACKGROUND

• 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.

  PMID: 39779624 BACKGROUND

• 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.

  PMID: 39872809 BACKGROUND

• 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.

  PMID: 39234659 BACKGROUND

• 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.

  PMID: 39724249 BACKGROUND

• 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.

  PMID: 33730748 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

On each DNA sample, high-throughput NGS methodology will be performed, able to recognize even very limited amounts of resistant mutations in the RT, protease and integrase gene. Samples will be destroyed after analyses.

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Cristina Mussini, Full Professor, MD

CONTACT

+390594222466; cristina.mussini@unimore.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full Professor, MD

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 2, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)