protocolSection identificationModule nctId: NCT06289361, orgStudyIdInfo id: IMEA 070, briefTitle: Cohort IMEA 070 -Lenacapavir Compassional, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-04-15, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba, class: OTHER, collaborators name: Saint-Louis Hospital, Paris, France, collaborators name: Bichat Hospital, collaborators name: Saint Antoine University Hospital, collaborators name: Institut National de la Santé Et de la Recherche Médicale, France, descriptionModule briefSummary: Immunovirological follow-up and safety of HIV-infected patients receiving lenacapavir under compassionate access in France between 01/01/2021 and 12/31/2023, conditionsModule conditions: HIV Infections, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 58, type: ESTIMATED, outcomesModule primaryOutcomes measure: proportion of participants with plasma HIV RNA < 50 copies/ml 26 weeks after first LEN injection, secondaryOutcomes measure: incidence of side effects and laboratory abnormalities on LEN treatment, secondaryOutcomes measure: evolution of HIV-1 or HIV-2 RNA over time, secondaryOutcomes measure: evolution of CD4, CD8 lymphocyte counts and CD4/CD8 ratio over time, secondaryOutcomes measure: Proportion of patients with capsid resistance mutations emergence at time of virological failure response) compared with initiation (D0), secondaryOutcomes 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, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hopital Zobda Quitman, city: Fort-de-France, state: Martinique, zip: 97261, country: France, contacts name: Ornella OC CABRAS, PhD, role: CONTACT, phone: +33.5.96.55.23.01, email: ornella.cabras@chu-fort-de-france.fr, contacts name: Ornella OC CABRAS, PhD, role: PRINCIPAL_INVESTIGATOR, locations facility: Hopital Avicenne, city: Bobigny, zip: 93000, country: France, contacts name: Frederic FM MECHAI, MD, role: CONTACT, phone: +33.1.48.95.54.21, email: frederic.mechai@aphp.fr, contacts name: Frederic FM MECHAI, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.9, lon: 2.45, locations facility: Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses, city: Bordeaux, zip: 33000, country: France, contacts name: Pauline PP PERREAU, role: CONTACT, phone: 33.5.57.82.11.03, email: pauline.perreau@chu-bordeaux.fr, contacts name: Arnaud AD DESCLAUX, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.84044, lon: -0.5805, locations facility: Hopital Saint-Andre, city: Bordeaux, zip: 33075, country: France, contacts name: Sabrina SC CALDATO, role: CONTACT, phone: +33.5.56.79.57.33, email: sabrina.caldato@chu-bordeaux.fr, contacts name: Fabrice FB BONNET, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.84044, lon: -0.5805, locations facility: Hopital Raymond Poincare, city: Garches, zip: 92380, country: France, contacts name: Rezak RM MAHREZ, role: CONTACT, phone: +33.1.47.10.46.65, email: rezak.mahrez@aphp.fr, contacts name: Pierre PT DE TRUCHIS, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.84226, lon: 2.18232, locations facility: C.H.D de Vendee, city: La Roche Sur Yon, zip: 85925, country: France, contacts name: Hélène HP PELERIN, role: CONTACT, phone: +33.2.51.44.65.72, email: helene.pelerin@ght85.fr, contacts name: Philippe PP PERRE, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.66667, lon: -1.43333, locations facility: André Mignot Hospital, city: Le Chesnay, zip: 78150, country: France, contacts name: Marie-Charlotte MCDC DE CARNE, MD, role: CONTACT, phone: +33.1.39.63.88.56, email: mcdecarne@ght78sud.fr, contacts name: Marie-Charlotte MCDC DE CARNE, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.8222, lon: 2.12213, locations facility: Centre Hospitalier Bretagne Sud - Hôpital du Scorff, city: Lorient, zip: 56100, country: France, contacts name: Jérémie JP PASQUIER, MD, role: CONTACT, phone: +33.2.97.06.74.86, email: j.pasquier@ghbs.bzh, contacts name: Jérémie JP PASQUIER, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.75, lon: -3.36667, locations facility: CHU de Nice, city: Nice, zip: 06200, country: France, contacts name: Sophie SB BREAUD, role: CONTACT, phone: +33 4 92 03 90 90, email: breaud.s@chu-nice.fr, contacts name: David DC CHIRIO, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70313, lon: 7.26608, locations facility: Hôpital Hotel Dieu, city: Paris, zip: 75004, country: France, contacts name: Valérie VLB LE BAUT, role: CONTACT, phone: +33.1.42.34.81.65, email: valerie.le-baut@aphp.fr, contacts name: Jean-Paul JPV VIARD, PHD, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hopital Saint Antoine, city: Paris, zip: 75012, country: France, contacts name: Rym RM MONARD, role: CONTACT, phone: +33 1 86 69 71 21, email: rym.monard@aphp.fr, contacts name: Karine KL LACOMBE, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Groupe Hospitalier Pitié-Salpêtrière - Service de Maladies Infectieuses et Tropicales, city: Paris, zip: 75013, country: France, contacts name: Malikhone MC CHANSOMBAT, role: CONTACT, phone: +33.1.42.16.01.74, email: malikhone.chansombat@aphp.fr, contacts name: Sophie SS SEANG, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hopital Necker, city: Paris, zip: 75015, country: France, contacts name: Elisabete EGP GOMES PIRES, role: CONTACT, phone: +33.1.44.49.2719, email: elisabete.gomes-pires@aphp.fr, contacts name: Carole CL LOUISIN, role: CONTACT, phone: +33.1.44.49.55.72, contacts name: Claudine CD DUVIVIER, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Bichat Hospital, city: Paris, zip: 75018, country: France, contacts name: ZELIE JULIA, role: CONTACT, phone: 40257057, phoneExt: 331, email: zelie.julia@aphp.fr, contacts name: ROLAND LANDMAN, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Delafontaine, city: Saint-Denis, zip: 93200, country: France, contacts name: Awa AN N'DIAYE, role: CONTACT, phone: +33.1.42.35.61.40, phoneExt: 6809, email: awa.ndiaye2@aphp.fr, contacts name: Naomie NS SAYRE, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.93326, lon: 2.36666, locations facility: Hopital Foch, city: Suresnes, zip: 92150, country: France, contacts name: Amina AF FADLI, role: CONTACT, phone: +33.1.46.25.11.73, email: a.fadli@hopital.foch.org, contacts name: David DZ ZUCMAN, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.87143, lon: 2.22929, hasResults: False