Cohort IMEA 070 -Lenacapavir Compassional

March 20, 2024 updated by: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Immunovirological Follow-up and Safety of HIV-infected Patients Receiving Lenacapavir Under Compassionate Access in France Between 01/01/2021 and 12/31/2023

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 Overview

Status

Not yet recruiting

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bobigny, France, 93000
        • Hôpital Avicenne
        • Contact:
        • Principal Investigator:
          • Frederic FM MECHAI, MD
      • Bordeaux, France, 33075
        • Hôpital Saint-André
        • Contact:
        • Principal Investigator:
          • Fabrice FB BONNET, PhD
      • Bordeaux, France, 33000
        • Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses
        • Contact:
        • Principal Investigator:
          • Arnaud AD DESCLAUX, MD
      • Garches, France, 92380
        • Hôpital Raymond Poincaré
        • Principal Investigator:
          • Pierre PT DE TRUCHIS, PhD
        • Contact:
      • La Roche Sur Yon, France, 85925
        • C.H.D de Vendee
        • Contact:
        • Principal Investigator:
          • Philippe PP PERRE, PhD
      • Le Chesnay, France, 78150
        • André Mignot Hospital
        • Contact:
        • Principal Investigator:
          • Marie-Charlotte MCDC DE CARNE, MD
      • Lorient, France, 56100
        • Centre Hospitalier Bretagne Sud - Hôpital du Scorff
        • Contact:
        • Principal Investigator:
          • Jérémie JP PASQUIER, MD
      • Nice, France, 06200
        • CHU de Nice
        • Contact:
        • Principal Investigator:
          • David DC CHIRIO, MD
      • Paris, France, 75012
        • Hopital Saint Antoine
        • Principal Investigator:
          • Karine KL LACOMBE, MD, PhD
        • Contact:
      • Paris, France, 75015
        • Hopital Necker
        • Principal Investigator:
          • Claudine CD DUVIVIER, PhD
        • Contact:
        • Contact:
          • Carole CL LOUISIN
          • Phone Number: +33.1.44.49.55.72
      • Paris, France, 75004
        • Hôpital Hotel Dieu
        • Contact:
        • Principal Investigator:
          • Jean-Paul JPV VIARD, PHD, MD
      • Paris, France, 75018
        • Bichat Hospital
        • Contact:
        • Principal Investigator:
          • ROLAND LANDMAN, MD
      • Paris, France, 75013
        • Groupe Hospitalier Pitié-Salpêtrière - Service de Maladies Infectieuses et Tropicales
        • Contact:
        • Principal Investigator:
          • Sophie SS SEANG, MD
      • Saint-Denis, France, 93200
        • Delafontaine
        • Contact:
        • Principal Investigator:
          • Naomie NS SAYRE, MD
      • Suresnes, France, 92150
        • Hôpital FOCH
        • Contact:
        • Principal Investigator:
          • David DZ ZUCMAN, MD
    • Martinique
      • Fort-de-France, Martinique, France, 97261

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
proportion of participants with plasma HIV RNA < 50 copies/ml 26 weeks after first LEN injection
Time Frame: Week 26
Week 26

Secondary Outcome Measures

Outcome Measure
Time Frame
incidence of side effects and laboratory abnormalities on LEN treatment
Time Frame: between week 26 and Week 52
between week 26 and Week 52
evolution of HIV-1 or HIV-2 RNA over time
Time Frame: between week 26 and Week 52
between week 26 and Week 52
evolution of CD4, CD8 lymphocyte counts and CD4/CD8 ratio over time
Time Frame: between week 26 and Week 52
between week 26 and Week 52
Proportion of patients with capsid resistance mutations emergence at time of virological failure response) compared with initiation (D0)
Time Frame: between Week 26 and Week 52
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
Time Frame: Week 26
Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France
Saint-Louis Hospital, Paris, France
Saint Antoine University Hospital
Bichat Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 15, 2024

Study Completion (Estimated)

July 30, 2024

Study Registration Dates

First Submitted

February 26, 2024

First Submitted That Met QC Criteria

February 26, 2024

First Posted (Actual)

March 1, 2024

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMEA 070

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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