Clinical Trials in France / NCT07402044
Starting soon
Observational
CABOTEGRAVIR/LENACAPAVIR DUAL LONG ACTING THERAPY (COHORT IMEA 074)
NCT07402044 · tracked via the Priya Life Science France tracker
Condition(s) studied
CABOTEGRAVIRLENACAPAVIR
Study 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.
Eligibility
* 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
Primary outcome measure(s)
- Percentage of participants with virological failure — Week 48
Two consecutive viral load (VL) measurements ≥50 copies/mL after having achieved VL \<50 copies/mL - Percentage of participants with virological failure — Week 24
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 — Week48
A VL ≥50 copies/mL
Trial sites (13)
| Facility | City | Region | Status |
|---|---|---|---|
| Victor Dupuy Hospital | Argenteuil | France | |
| Pellegrin Hospital | Bordeaux | France | |
| Saint André Hospital | Bordeaux | France | |
| Raymond poincaré Hospital | Garches | France | |
| Franco-British Hospital (Fbh) | Levallois-Perret | France | |
| Hotel Dieu Hospital | Nantes | France | |
| Archet 1Hospital | Nice | France | |
| Bichat Claude Bernard Hospital | Paris | France | |
| Hotel Dieu Hospital | Paris | France | |
| Necker Hospital | Paris | France | |
| Pitié Salpêtrière Hospital | Paris | France | |
| Saint Antoine Hospital | Paris | France | |
| Tourcoing Hospital | Tourcoing | France |
More Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba trials in France
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07402044 on ClinicalTrials.gov ↗ ← All trials in France