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Cabotegravir and Lenacapavir Long-Acting Treatment in People With HIV-1

Follows adults with HIV-1 using long-acting cabotegravir and lenacapavir to check results and safety.

Plain-language title generated from the registry record
Registry title: CABOTEGRAVIR/LENACAPAVIR DUAL LONG ACTING THERAPY (COHORT IMEA 074)

Key facts

Where
Argenteuil, Bordeaux, Garches, Levallois-Perret, Nantes, Nice, Paris, and Tourcoing, FranceSee the 13 sites

Where in France

  • Victor Dupuy HospitalArgenteuil, FranceNo longer taking part
  • Pellegrin HospitalBordeaux, FranceNo longer taking part
  • Saint André HospitalBordeaux, FranceNo longer taking part
  • Raymond-Poincare HospitalGarches, FranceNo longer taking part
  • Franco-British Hospital (Fbh)Levallois-Perret, FranceNo longer taking part
  • Hotel Dieu HospitalNantes, FranceNo longer taking part
  • Archet 1HospitalNice, FranceNo longer taking part
  • Bichat-Claude Bernard HospitalParis, FranceNo longer taking part
  • Hôtel Dieu HospitalParis, FranceNo longer taking part
  • Necker HospitalParis, FranceNo longer taking part
  • Pitié Salpêtrière HospitalParis, FranceNo longer taking part
  • Saint-Antoine HospitalParis, FranceNo longer taking part
  • Tourcoing HospitalTourcoing, FranceNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Trial code
NCT07402044
Record updated
27 March 2026
Original description
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.Read full original descriptionShow less

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

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.

Exclusion: Participants' objection to the use of follow-up data.

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.

ClinicalTrials.gov NCT07402044