Pilot study, open label, multicenter, evaluating dual antiretroviral therapy with long-acting cabotegravir/lenacapavir IMEA 069 - CALENDULA

Trial details

Who runs it

Inst Medecine Epidemiologie Appliquee

Trial code

EU 2024-516028-33-01

Record updated

2025. március 21.

Original description

To evaluate the efficacy of maintenance dual antiretroviral therapy with cabotegravir/lenacapavir over 48 weeks of follow-up. Efficacy being defined by the absence of virological failure: 2 successive CVs ≥50 copies/mL or a CV ≥50 copies/mL followed by definitive cessation of treatment or follow-up, or a CV ≥50 copies/mL at W48)Read full original descriptionShow less

(CAbotégravir LENacapavir DUal Long Acting). Phase II, Pilot study, open label, multicenter, evaluating dual antiretroviral therapy with long-acting cabotegravir/lenacapavir IMEA 069 - CALENDULA

To evaluate the efficacy of maintenance dual antiretroviral therapy with cabotegravir/lenacapavir over 48 weeks of follow-up. Efficacy being defined by the absence of virological failure: 2 successive CVs ≥50 copies/mL or a CV ≥50 copies/mL followed by definitive cessation of treatment or follow-up, or a CV ≥50 copies/mL at W48)

Inclusion: Age ≥ 18 years; For women at risk of pregnancy, commitment to use an effective method of contraception for the duration of the study; Affiliated or beneficiary of a social security scheme (article L1121-11 of the French Public Health Code),; Free, informed, written consent, signed by the person and the investigator no later than the day of inclusion and before any examination carried out as part of the study; HIV-1 infection; Stable oral antiretroviral treatment for at least 6 months; Multi-treated patients who have received multiple lines of antiretroviral treatment - Undetectable patients with CV < 50 copies/mL in the last 6 months (a single blip between 50 and 200 copies/mL in the last 6 months is allowed) and eligible to switch to the lenacapavir/cabotegravir strategy on the basis of a collegial decision by clinicians, virologists and pharmacologists following a multidisciplinary meeting due to - the presence of resistance mutations, including to NNRTIs - or oral drug intolerance - or drug-drug interactions - Detectable, virologically uncontrolled HIV viral load ≥ 200 c/mL in the last 12 months who is eligible to switch to the lenacapavir/cabotegravir strategy based on a collegial decision by clinicians, virologists and pharmacologists following a multidisciplinary meeting due to - the presence of resistance mutations, including to NNRTIs - or oral drug intolerance - or drug-drug interactions; ASAT and ALAT < 3N; Creatinine Clearance> 60 mL/min (CKD-EPI); Haemoglobin > 10 g/dL; Platelets > 100 000/mm3; Commitment to use preventive and protective means of sexual intercourse for the duration of the trial.

Exclusion: Taking medication contraindicated with the trial treatment; Treatment with interferon, interleukin or any other immunotherapy or chemotherapy in progress; HIV-2 infection or HIV-1/HIV2 co-infection; HIV-1 subtype A6/A1; Chronic active viral hepatitis B with positive Hbs antigen; Active chronic viral hepatitis C requiring specific treatment over the next 48 weeks; Active opportunistic infection, or acute treatment for opportunistic infection; Any condition (alcohol, drugs, neurological or neuropsychiatric disorders, etc.) likely to compromise tolerance of treatment and/or patient compliance with treatment and adherence to the protocol, as judged by the investigator; Major incapacity, legal protection, guardianship or curatorship; Project to move in a non-study site within the next 18 months; BMI ≥ 30kg/m²; Women who are breastfeeding, pregnant or refusing contraception.

EU CTIS 2024-516028-33-01