NCT07402044

CABOTEGRAVIR/LENACAPAVIR DUAL LONG ACTING THERAPY (COHORT IMEA 074)

CAbotégravir LENacapavir DUal Long Acting). Immuno-virological Monitoring and Safety Assessment of HIV-1 Infected Patients Receiving a Long-Acting Antiretroviral Combination of Cabotegravir and Lenacapavir

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this national study is to evaluate the virological success of long-acting antiretroviral therapy combining cabotegravir and lenacapavir. The study involves patients who have been receiving this treatment for one year or those for whom the physician decides to initiate it. It also aims to evaluate the tolerability of the treatment and changes in the participants' immunovirological profile during follow-up.

Detailed description

The CALENDULA cohort is a French multicenter study of people living with HIV (PLHIV) receiving long-acting dual therapy combining cabotegravir and lenacapavir (CAB/LEN) for at least 48 weeks. The study has two parts: Retrospective part: includes patients who started treatment between July 2024 and the date of the last available follow-up. Prospective part: includes patients for whom the decision to initiate treatment is made during a 12-month recruitment period, with 48 weeks of follow-up. No specific intervention is planned; data are simply collected from medical records. Information will be collected at the following times after the start of treatment: D0, W24, and W48. The primary objective is to describe the virological response and tolerance of CAB/LEN dual therapy over 48 weeks. Virological success is defined as maintaining a viral load (VL) \< 50 copies/mL or suppression of VL at W48 without interruption of treatment. The efficacy criterion is the virological failure rate at S48. The study aims to evaluate the feasibility and tolerability of this innovative therapeutic combination in order to prepare for a future larger-scale study on cabotegravir/lenacapavir.

Conditions

• CABOTEGRAVIR
• LENACAPAVIR

Timeline

• Start date: 2026-03-15
• Primary completion: 2028-03-15
• Completion: 2028-03-15
• First posted: 2026-02-11
• Last updated: 2026-03-27

Locations

13 sites across 1 country: France