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

Prior treatment

• Current or previous use of Long-acting injectable ART.
• Receipt of broadly neutralising antibodies within the past 2 years.
• 2 or more VL determinations \> 50 copies/ml in the 2 years previous to ATI.
• Any concomitant immunosuppressive medication.

Other illness

• Active HBV or HCV co-infection (defined by positive HBs Antigen and positive HCV-RNA)
• Past or current evidence of severe opportunistic infection such as CMV retinitis or cryptococcalmeningitis.
• Active or substantial cardiovascular, kidney or liver disease.
• Current cancer of any type or any history of HIV-related cancer.
• Active or latent tuberculosis infection.
• Any significant co-morbidity at discretion of the investigator that may be jeopardized in case of incomplete HIV viral suppression.
• History of antiretroviral drug resistance and no other options beyond their current regimen.

Other

• Pregnant or breastfeeding.
• Men or women of childbearing potential unable or unwilling to use highly efficient contraceptive measures\*\* from the beginning until the end of the study.

• 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.
• Having a favourable genotype AND a favourable NK phenotype defined by
  • the presence of HLAB35 +, Bw4 \> 1 + 2 threonine or HLA Bw4 \> 2 + 2 threonine AND
  • the presence of a percentage \> 16% in NK memory-like cells displaying CD57+, NKG2C, KIR3DL1 and KIR2DL3 markers.
• On active ART for a minimum of 2 years.
• Undetectable VL at the moment of inclusion and ATI.
• CD4 counts ≥500 at the moment of ATI.
• CD4 T cell count nadir ≥ 200 (for people who was diagnosed in primary infection) and ≥ 350 (for chronic infections).
• Participant agrees to follow HIV preventive practices.
• Women of child-bearing potential\* must have a negative pregnancy test in serum or urine before the inclusion in the study.