Cohort IMEA 070 -Lenacapavir Compassional
Immunovirological Follow-up and Safety of HIV-infected Patients Receiving Lenacapavir Under Compassionate Access in France Between 01/01/2021 and 12/31/2023
1 other identifier
observational
58
1 country
23
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2024
Shorter than P25 for all trials
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2024
CompletedFirst Posted
Study publicly available on registry
March 1, 2024
CompletedStudy Start
First participant enrolled
April 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2024
CompletedOctober 26, 2024
October 1, 2024
14 days
February 26, 2024
October 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
proportion of participants with plasma HIV RNA < 50 copies/ml 26 weeks after first LEN injection
Week 26
Secondary Outcomes (5)
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
Proportion of patients with capsid resistance mutations emergence at time of virological failure response) compared with initiation (D0)
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
Eligibility Criteria
Patients already followed and identified in the centers and having received lenacapavir in compassionate access between January 01st, 2021 and December 20th, 2022
You may qualify if:
- Patients who received compassionate access to LEN between 01/01/2021 and 20/12/202
You may not qualify if:
- Participant opposition to use of follow-up data
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Centre Hospitalier de la Côte Basque
Bayonne, France, 64100, France
Hôpital Béclère
Clamart, France, 92140, France
Hôpital de la Rochelle
La Rochelle, France, 17000, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, France, 94270, France
Hôpital Max Fourestier
Nanterre, France, 92000, France
CHU La Source
Orléans, France, 45100, France
Hôpital Félix Guyon
Saint-Denis, LA Reunion, 97400, France
Hopital Zobda Quitman
Fort-de-France, Martinique, 97261, France
Hopital Avicenne
Bobigny, 93000, France
Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses
Bordeaux, 33000, France
Hopital Saint-Andre
Bordeaux, 33075, France
Hopital Raymond Poincare
Garches, 92380, France
C.H.D de Vendee
La Roche-sur-Yon, 85925, France
André Mignot Hospital
Le Chesnay, 78150, France
Centre Hospitalier Bretagne Sud - Hôpital du Scorff
Lorient, 56100, France
CHU de Nice
Nice, 06200, France
Hôpital Hotel Dieu
Paris, 75004, France
Hopital Saint Antoine
Paris, 75012, France
Groupe Hospitalier Pitié-Salpêtrière - Service de Maladies Infectieuses et Tropicales
Paris, 75013, France
Hopital Necker
Paris, 75015, France
Bichat Hospital
Paris, 75018, France
Delafontaine
Saint-Denis, 93200, France
Hopital Foch
Suresnes, 92150, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2024
First Posted
March 1, 2024
Study Start
April 1, 2024
Primary Completion
April 15, 2024
Study Completion
November 30, 2024
Last Updated
October 26, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share