CABOTEGRAVIR/LENACAPAVIR DUAL LONG ACTING THERAPY (COHORT IMEA 074)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: CABOTEGRAVIR, LENACAPAVIR. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Primary outcome measures
- Percentage of participants with virological failure [Time frame: Week 48]
- Percentage of participants with virological failure [Time frame: Week 24]
- Percentage of participants with virological failure [Time frame: Week48]
Secondary outcome measures (8)
- 1. Percentage of participants with therapeutic success using the FDA Snapshot approach (defined as absence of virological failure, permanent treatment discontinuation, or loss to follow-up). [Time frame: Week48]
- 2. Percentage of participants with viruses showing resistance-associated mutations. [Time frame: Week 48]
- 3. Percentage of participants experiencing at least one "blip" [Time frame: from Week 24 to week 48]
- 4. Plasma concentrations of antiretroviral drugs [Time frame: from Week 24 to week 48]
- 5. Changes in CD4 and CD8 T-cell counts and in the CD4/CD8 ratio [Time frame: from enrollment to the end of treatment at 48 weeks]
- 6. Incidence of adverse events and biological abnormalities [Time frame: from enrollment to the end of the treatment at week 48]
- 7. Changes in body weight and BMI [Time frame: from the enrollment to the end the treatment at week 48]
- 8. Changes in metabolic parameters [Time frame: From the enrollment to the end of treatment at week 48]
Eligibility criteria
- Age ≥18 years
- HIV-1 infection
- Patients who started taking cabotegravir combined with lenacapavir between July 2024 and the one-year follow-up, or who are due to start taking the CAB/LEN combination.
- Patients who are due to start the CAB/LEN combination following a medical decision.
Exclusion criteria
- Participants' objection to the use of follow-up data
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 13 centers
- Victor Dupuy Hospital — Argenteuil
- Pellegrin Hospital — Bordeaux
- Saint André Hospital — Bordeaux
- Raymond poincaré Hospital — Garches
- Franco-British Hospital (Fbh) — Levallois-Perret
- Hotel Dieu Hospital — Nantes
- Archet 1Hospital — Nice
- Bichat Claude Bernard Hospital — Paris
- … and 5 more centers
Identifiers
NCT: NCT07402044 · 2025-A02118-41 · IDRCB