CABOTEGRAVIR, LENACAPAVIR
Conditions
Keywords
Lenacapavir, Cabotegravir, HIV, Multicentre cohort
Brief 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.
Interventions
None listed
Sponsors
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
INSERM UMR S 1136
ANRS, Emerging Infectious Diseases
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with virological failure | Week 48 | Two consecutive viral load (VL) measurements ≥50 copies/mL after having achieved VL \<50 copies/mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | Week48 | — |
| 2. Percentage of participants with viruses showing resistance-associated mutations. | Week 48 | — |
| 3. Percentage of participants experiencing at least one "blip" | from Week 24 to week 48 | — |
| 4. Plasma concentrations of antiretroviral drugs | from Week 24 to week 48 | — |
| 5. Changes in CD4 and CD8 T-cell counts and in the CD4/CD8 ratio | from enrollment to the end of treatment at 48 weeks | — |
| 6. Incidence of adverse events and biological abnormalities | from enrollment to the end of the treatment at week 48 | — |
| 7. Changes in body weight and BMI | from the enrollment to the end the treatment at week 48 | — |
| 8. Changes in metabolic parameters | From the enrollment to the end of treatment at week 48 | changes in Total cholesterol, HDL, LDL, Triglycerid, Glyceamia levels |
Countries
France
Contacts
CONTACTRoland LANDMAN
CONTACTAïda BENALYCHERIF
PRINCIPAL_INVESTIGATORRoland LANDMAN
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Outcome results
None listed