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NCT06289361 Clinical Trial

Cohort IMEA 070 -Lenacapavir Compassional

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06289361
Other study ID # IMEA 070
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2024
Est. completion date July 30, 2024

Study information
Verified date March 2024
Source Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Description:

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 58
Est. completion date July 30, 2024
Est. primary completion date April 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
France Hopital Avicenne Bobigny
France Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses Bordeaux
France Hopital Saint-Andre Bordeaux
France Hopital Zobda Quitman Fort-de-France Martinique
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 Bichat Hospital Paris
France Groupe Hospitalier Pitié-Salpêtrière - Service de Maladies Infectieuses et Tropicales Paris
France Hôpital Hotel Dieu Paris
France Hopital Necker Paris
France Hopital Saint Antoine Paris
France Delafontaine Saint-Denis
France Hopital Foch Suresnes

Sponsors (5)
Lead Sponsor Collaborator
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba Bichat Hospital, Institut National de la Santé Et de la Recherche Médicale, France, Saint Antoine University Hospital, Saint-Louis Hospital, Paris, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary proportion of participants with plasma HIV RNA < 50 copies/ml 26 weeks after first LEN injection Week 26
Secondary incidence of side effects and laboratory abnormalities on LEN treatment between week 26 and Week 52
Secondary evolution of HIV-1 or HIV-2 RNA over time between week 26 and Week 52
Secondary evolution of CD4, CD8 lymphocyte counts and CD4/CD8 ratio over time between week 26 and Week 52
Secondary Proportion of patients with capsid resistance mutations emergence at time of virological failure response) compared with initiation (D0) between Week 26 and Week 52
Secondary 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
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