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.
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.
Participants' objection to the use of follow-up data
people living with HIV (PLHIV) in France, receiving long-acting dual therapy with cabotegravir/lenacapavir for at least 48 weeks, comprising: (i) a retrospective component, including patients who started this treatment from July 2024 until the last available follow-up data collection; (ii) a prospective component, including patients for whom a medical decision to initiate this treatment is made during a 12-month recruitment period, with a planned follow-up of 48 weeks.
Cohort
Other
Not listed
Percentage of participants with virological failure
Two consecutive viral load (VL) measurements ≥50 copies/mL after having achieved VL \<50 copies/mL
Percentage of participants with virological failure
ii. A single VL ≥50 copies/mL followed by permanent treatment discontinuation or loss to follow-up after previously achieving VL \<50 copies/mL; or discontinuation with VL ≥50 copies/mL
Percentage of participants with virological failure
A VL ≥50 copies/mL
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).
2. Percentage of participants with viruses showing resistance-associated mutations.
3. Percentage of participants experiencing at least one "blip"
4. Plasma concentrations of antiretroviral drugs
3. Percentage of participants experiencing at least one "blip
Percentage of participants experiencing at least one "blip
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Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Lead sponsor
INSERM UMR S 1136
Collaborator
ANRS, Emerging Infectious Diseases
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
