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