CAbotégravir LENacapavir DUal Long Acting

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

January 15, 2025

Primary Completion Date

July 15, 2026

Study Completion Date

September 15, 2026

Conditions
HIV1 InfectionMulti-treated Patients Who Have Received Multiple Lines of Antiretroviral TreatmentCABOTEGRAVIRLENACAPAVIRStable Oral Antiretroviral Treatment for At Least 6 Months
Interventions
DRUG

his is a prospective, single-arm, multicentre, non-randomised phase II, pilot study designed to achieve or maintain virological success in participants who meet the prescribing criteria for lenacapavi

"cabotegravir initiation: daily oral route of 1 tablet 30 mg at Day 0 to week 4 Cabotegravir maintennace: Every 8 weeks (+/- 1 week) intramuscular injection from week 8 at week 48.~Lenacapavir initiation: Subcutaneous injection (927mg/3ml),ie 2 injections of 463,5mg/1,5mL in 2 distinct abdominal sites + orale route of 2 tablets of 300mg (ie 600 mg) at Day 0 and at day 1: orale route of 2 tablets of 300mg (ie 600 mg) Lenacapavir maintenance: Subcutaneous injection (927mg/3ml),ie 2 injections of 463,5mg/1,5mL in 2 distinct abdominal sites every 24 weeks (+/-1 week) from Day 0 to Week 48"

Trial Locations (12)

75012

Hopital Saint Antoine, Paris

75013

Hopital Pitié Salpêtrière, Paris

75015

Hopital Necker, Paris

75018

Hopital Bichat Claude Bernard, Paris

Unknown

Hopital Saint André, Bordeaux

Hopiytal Pellegrin, Bordeaux

Centre hospitalier François Mitterrand, Dijon

Hopital raymond Poincaré, Garches

Hôpital Franco-Britannique, Levallois-Perret

CHU de nantes- Hotel Dieu, Nantes

Chu- Nice Archet, Nice

Centre hospitalier de Tourcoing, Tourcoing

All Listed Sponsors
collaborator

ANRS, Emerging Infectious Diseases

OTHER_GOV

lead

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

OTHER

NCT06657885 - CAbotégravir LENacapavir DUal Long Acting | Biotech Hunter | Biotech Hunter