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

Prior treatment

• Taking medication contraindicated with the trial treatment
• Treatment with interferon, interleukin or any other immunotherapy or chemotherapy in progress.

Other illness

• 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.

Other

• 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

• 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