A Clinical Trial of Analytical Treatment Interruption in People With HIV With a Highly Favourable Profile

A pilot single exploratory clinical trial of ATI in a selected sample of PWH sharing specific genetic, phenotypic and clinical characteristics.

Inclusion Criteria: 1. Men or women aged 18 and ≤65 years old who were screened and pre-selected in the exploratory study HCB/2023/0510 and who provide written informed consent to participate. 2. Having a favourable genotype AND a favourable NK phenotype defined by 1. the presence of HLAB35 +, Bw4 \> 1 + 2 threonine or HLA Bw4 \> 2 + 2 threonine AND 2. the presence of a percentage \> 16% in NK memory-like cells displaying CD57+, NKG2C, KIR3DL1 and KIR2DL3 markers. 3. On active ART for a minimum of 2 years. 4. Undetectable VL at the moment of inclusion and ATI. 5. CD4 counts ≥500 at the moment of ATI. 6. CD4 T cell count nadir ≥ 200 (for people who was diagnosed in primary infection) and ≥ 350 (for chronic infections). 7. Participant agrees to follow HIV preventive practices. 8. Women of child-bearing potential\* must have a negative pregnancy test in serum or urine before the inclusion in the study. Exclusion Criteria: 1. Pregnant or breastfeeding. 2. Active HBV or HCV co-infection (defined by positive HBs Antigen and positive HCV-RNA) 3. Past or current evidence of severe opportunistic infection such as CMV retinitis or cryptococcalmeningitis. 4. Active or substantial cardiovascular, kidney or liver disease. 5. Current cancer of any type or any history of HIV-related cancer. 6. Active or latent tuberculosis infection. 7. Any significant co-morbidity at discretion of the investigator that may be jeopardized in case of incomplete HIV viral suppression. 8. Current or previous use of Long-acting injectable ART. 9. History of antiretroviral drug resistance and no other options beyond their current regimen. 10. Receipt of broadly neutralising antibodies within the past 2 years. 11. 2 or more VL determinations \> 50 copies/ml in the 2 years previous to ATI. 12. Any concomitant immunosuppressive medication. 13. Men or women of childbearing potential unable or unwilling to use highly efficient contraceptive measures\*\* from the beginning until the end of the study.