Clinical trial NCT06289361: Cohort IMEA 070 -Lenacapavir Compassional
Official title: Immunovirological Follow-up and Safety of HIV-infected Patients Receiving Lenacapavir Under Compassionate Access in France Between 01/01/2021 and 12/31/2023
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: HIV Infections
Keywords: Lenacapavir under compassionate access
France
Cohort
Lead sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Sponsor class: OTHER
Collaborators: name: Saint-Louis Hospital, Paris, France
name: Bichat Hospital
name: Saint Antoine University Hospital
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2024-03-01
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients already followed and identified in the centers and having received lenacapavir in compassionate access between January 01st, 2021 and December 20th, 2022

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

Eligibility criteria: 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

Primary outcomes:
measure: proportion of participants with plasma HIV RNA < 50 copies/ml 26 weeks after first LEN injection
timeFrame: Week 26
Secondary outcomes:
measure: incidence of side effects and laboratory abnormalities on LEN treatment
timeFrame: between week 26 and Week 52
measure: evolution of HIV-1 or HIV-2 RNA over time
timeFrame: between week 26 and Week 52
measure: evolution of CD4, CD8 lymphocyte counts and CD4/CD8 ratio over time
timeFrame: between week 26 and Week 52
measure: Proportion of patients with capsid resistance mutations emergence at time of virological failure response) compared with initiation (D0)
timeFrame: between Week 26 and Week 52
measure: 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
timeFrame: Week 26
Other outcomes:
Locations:
city: Saint-Denis
country: France
facility: Hôpital Félix Guyon
state: La Reunion
city: Fort-de-France
country: France
facility: Hopital Zobda Quitman
state: Martinique
city: Bayonne
country: France
facility: Centre Hospitalier de la Côte Basque
city: Bobigny
country: France
facility: Hopital Avicenne
city: Bordeaux
country: France
facility: Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses
city: Bordeaux
country: France
facility: Hopital Saint-Andre
city: Clamart
country: France
facility: Hôpital Béclère
city: Garches
country: France
facility: Hopital Raymond Poincare
city: Kremlin Bicetre
country: France
facility: Hôpital Bicêtre
city: La Roche Sur Yon
country: France
facility: C.H.D de Vendee
city: La Rochelle
country: France
facility: Hôpital de la Rochelle
city: Le Chesnay
country: France
facility: André Mignot Hospital
city: Lorient
country: France
facility: Centre Hospitalier Bretagne Sud - Hôpital du Scorff
city: Nanterre
country: France
facility: Hôpital Max Fourestier
city: Nice
country: France
facility: CHU de Nice
city: Orleans
country: France
facility: CHU La Source
city: Paris
country: France
facility: Hôpital Hotel Dieu
city: Paris
country: France
facility: Hopital Saint Antoine
city: Paris
country: France
facility: Groupe Hospitalier Pitié-Salpêtrière - Service de Maladies Infectieuses et Tropicales
city: Paris
country: France
facility: Hopital Necker
city: Paris
country: France
facility: Bichat Hospital
city: Saint-Denis
country: France
facility: Delafontaine
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
References: