Immunotherapy With Baricitinib and Sirolimus, Alone and in Combination, for the Control of HIV-1 Replication After Antiretroviral Treatment Interruption

Inclusion Criteria

• •Age ≤ 18 years and ≥ 65 years,
• •Weight ≥ 50 kg and ≤ 100 kg,
• •HIV-1 infection having been diagnosed at primary infection stage with an HIV-1 RNA VL \> 1,000 copies/mL and either a negative or incomplete WB \[0-5\] bands or IB \[0-3\] bands and/or a previous negative HIV-1 ELISA within the past 3 months,
• •Having initiated ART within 2 months of primary HIV-1 infection diagnosis,
• •Having received ART continuously without interruption,
• •Receiving ART for at least 1 year prior to enrollment,
• •Receiving DTG-, BIC-, RAL-, or RPV-based ART (PI-, EVG/c-, NVP-, EFV-, ETR- or DOR-based ART must have been switched to DTG-, BIC-, RAL-, or RPV-based ART at W-8).
• •Sustained HIV-1 plasma viral load ≤ 50 copies/mL for ≥ 6 months prior to enrollment (with at least two measurements, including the screening value),
• •Blood CD4 T-cell count ≥ 500 cells/µL (on the last two measurements, including screening),
• •Willing to interrupt ART for ATI and change ART regimen before if required to avoid drug-drug interactions,
• •Willing to take valaciclovir 500 mg QD from W0 to W10 to prevent recurrence of herpes or herpes zoster,
• •If sexually active, willing to use a reliable method of reducing the risk of transmission to their sexual partners during treatment interruption (condoms or PrEP for their sexual partners).
• •If able to have children, willing to use a highly effective method of contraception (combined oral contraceptive pill; implanted contraceptive device, IUD/IUS; physiological or anatomical sterility for self of partner); willing to undergo blood bHCG at screening and before ATI.
• •Willing to comply with visit schedule and provide blood samples according to the protocol.
• •Written informed consent (at the latest on the day of the enrollment visit and before any exams to be performed in the context of the trial) (article L1122-1-1 of the French CSP).
• •Participant covered by Health Insurance (article L1121-11 of the French CSP).