Cohort IMEA 070 -Lenacapavir Compassional

Active, not recruiting

• Conditions: HIV Infections

• Registration Number: NCT06289361
• Lead Sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Brief Summary

Immunovirological follow-up and safety of HIV-infected patients receiving lenacapavir under compassionate access in France between 01/01/2021 and 12/31/2023

Detailed Description

Retrospective descriptive cohort of patients who received Lenacapavir under compassionate access in France with 50 patients in 25 sites in France

Study Timeline

• Study First Submitted: 2024-02-26
• Study First Submitted QC: 2024-02-26
• Study First Posted: 2024-03-01
• Study Start: 2024-04-01
• Primary Completion: 2024-04-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Patients who received compassionate access to LEN between 01/01/2021 and 20/12/202

Exclusion Criteria

• Absence of visits with virological assessment subsequent to inclusion visit
• Participant opposition to use of follow-up data

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
proportion of participants with plasma HIV RNA < 50 copies/ml 26 weeks after first LEN injection	Week 26

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with capsid resistance mutations emergence at time of virological failure response) compared with initiation (D0)	between Week 26 and Week 52
incidence of side effects and laboratory abnormalities on LEN treatment	between week 26 and Week 52
evolution of HIV-1 or HIV-2 RNA over time	between week 26 and Week 52
evolution of CD4, CD8 lymphocyte counts and CD4/CD8 ratio over time	between week 26 and Week 52
Determination by multivariate analysis of factors associated with virological success 26 weeks after the first LEN injection factors associated with virological control 26 weeks after the first LEN injection	Week 26

Trial Locations

Locations (23)

Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses; 🇫🇷 Bordeaux, France

Hopital Saint-Andre; 🇫🇷 Bordeaux, France

Hopital Raymond Poincare; 🇫🇷 Garches, France

C.H.D de Vendee; 🇫🇷 La Roche Sur Yon, France

André Mignot Hospital; 🇫🇷 Le Chesnay, France

Centre Hospitalier Bretagne Sud - Hôpital du Scorff; 🇫🇷 Lorient, France

CHU de Nice; 🇫🇷 Nice, France

Hôpital Hotel Dieu; 🇫🇷 Paris, France

Hôpital Félix Guyon; 🇫🇷 Saint-Denis, La Reunion, France

Centre Hospitalier de la Côte Basque; 🇫🇷 Bayonne, France

Hôpital Béclère; 🇫🇷 Clamart, France

Hôpital Bicêtre; 🇫🇷 Kremlin Bicetre, France

Hôpital de la Rochelle; 🇫🇷 La Rochelle, France

CHU La Source; 🇫🇷 Orleans, France

Hôpital Max Fourestier; 🇫🇷 Nanterre, France

Hopital Zobda Quitman; 🇫🇷 Fort-de-France, Martinique, France

Hopital Avicenne; 🇫🇷 Bobigny, France

Hopital Saint Antoine; 🇫🇷 Paris, France

Groupe Hospitalier Pitié-Salpêtrière - Service de Maladies Infectieuses et Tropicales; 🇫🇷 Paris, France

Hopital Necker; 🇫🇷 Paris, France

Bichat Hospital; 🇫🇷 Paris, France

Delafontaine; 🇫🇷 Saint-Denis, France

Hopital Foch; 🇫🇷 Suresnes, France