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

NCT07579546 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-05-12

No results posted yet for this study

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

Interventions

DRUG

Cabotegravir/Rilpivirine

Antiretroviral drugs from clinical practice

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Simona Di Giambenedetto · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-06-01
Completion
2027-06-01
FDA Drug
Yes

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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 NCT07579546 on ClinicalTrials.gov