PERsistance of Long-Acting inJEctable CAB+RPV in a Cohort of Virologically-suppressed PLWH: a Real-life Study

NCT07579546 | Not Yet Recruiting FDA Drug

• 1 other identifier: 18140
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

People living with HIV (PLWH) need to take antiretroviral therapy (ART) long-life. The development of new and more effective ART regimens has increased viral suppression and improved the recovery of immune function, leading to an extension of the lifespan of PLWH. However, antiretroviral drugs have short- and long-term side effects. In fact, ART has recently been reported as one of the significant factors associated with metabolic syndromes (obesity, liver disease, and factor). This insidious progression of long-term metabolic complications has become a new challenge for our clinics. Therefore, optimizing ART in the context of viral suppression is mandatory. In recent years, thanks to the availability of more potent drugs with a high genetic barrier, simplification strategies have been explored with various regimens containing fewer drugs for PLWH who are virologically suppressed on a standard three-drug regimen. Based on international guidelines, following the results of clinical trials, two-drug regimens are now recommended as pro-active switch strategies within preventive strategies to reduce morbidity in PLWH. Following the results of the ATALS-2M, FLAIR, and SOLAR studies, the long-acting parenteral regimen containing cabotegravir and rilpivirine (CAB+RPV), administered every 2 months, has been included in the guidelines as a pro-active switch strategy for maintaining virological suppression. Cabotegravir, a new integrase inhibitor (INI), has demonstrated high efficacy, excellent tolerability, and safety, with a higher-than-average genetic barrier. Rilpivirine is a non-nucloside reverse transcriptase inhibitor (NNRTI) with potent virological efficacy and a favorable safety profile compared to other NNRTIs. This type of strategy has several primary advantages: improve adherence, especially in complex PLWH, easier to integrate into daily activities, less likely to generate stigma and/or discrimination. Furthermore, intramuscular administration, bypassing intestinal metabolism, potentially reduces the severity of drug-drug interactions. In light of the growing attention to the metabolic impact of various antiretroviral therapy regimens and their associated adverse events, it is crucial to examine the tolerability of this injectable regimen as a medium- and long-term switching strategy. The results of the Phase 3 studies are based on populations with a short exposure to antiretroviral drugs, which may not be generalized to PLWH with a long history of ART, who represent the majority of patients in clinical practice in high-income countries. This study aims, in a clinical practice setting, to evaluate the cumulative probability of treatment discontinuation (TD) at 48 weeks in PLWH switching to the injectable LA CAB + RPV (LAI CAB + RPV) regimen from an oral regimen with rilpivirine/emtricitabine/tenofovir alafenamide fumarate (RPV + FTC + TAF).

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (1)

• Evaluation of persistance on LAI CAB+RPV over 48 weeks

  Evaluation of the proportion of PLWH remaining on LAI CAB+RPV without treatment discontinuation (TD) for any reasons over 48 weeks. TD will be considered at the occurrence of VF (defined as 2 consecutive HIV RNA levels ≥50 copies/mL or a single level ≥1000 copies/mL after initiation of LAI CAB+RPV) or at switching to another regimen for any reason. The primary endpoint will be estimated according to an Intention to treat (ITT) approach in which all the participants enrolled who received at least one dose of LAI CAB+RPV will be included: the week 48 analysis will take place after the last participant has its week 48 viral load.

  1 year

Interventions

Cabotegravir/Rilpivirine DRUG

Antiretroviral drugs from clinical practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

HIV patients who, according to clinical practice, are recommended to switch to LAI CAB+RPV from an oral regimen with RPV+FTC+TAF;

You may qualify if:

• Age ≥ 18 years
• HIV infection
• Virologically suppression (defined as VL\<50 copies/mL in at least two consecutive determinations with a minimum interval of at least two months±2weeks between each determination)
• Informed consent form signed

You may not qualify if:

• none

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Interventions

cabotegravir; Rilpivirine

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Simona Di Giambenedetto

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesca Lombardi, Phd

CONTACT

+390630155366; francesca.lombardi@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 12, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share