Phase 1/2 study of IMC-M113V in virologically suppressed chronic HIV infection

Prior treatment

• Recent diagnosis of an AIDS-defining condition within 90 days prior to screening excludes participation in Part 1. Any history of AIDS-defining condition excludes participation in Part 2.
• Individuals receiving an ART regimen containing a non-nucleoside reverse transcriptase inhibitor may not enrol in Part 2 unless willing and able to switch to a short-acting alternative prior to receiving their first dose of study drug.
• Recent immunotherapy medication Systemic treatment with steroids or any other immunosuppressive drug use
• Prior treatment with investigational HIV-targeted therapy
• Recent use of live vaccine
• Prior treatment with ImmTAC molecule

Other illness

• Confirmed HIV controller with HIV RNA consistently below 2000 copies/mL for at least 12 months and on ≥ 2 determinations.
• Hypersensitivity to study treatment or excipient Any medical condition that would interfere with the participation in the study
• Initiated ART within 12 weeks of a diagnosis of primary HIV infection (PHI) Diagnosis of PHI is confirmed by any of: a. positive HIV-1 serology preceded by a recent negative HIV-1 antibody (Ab) test, b. Negative HIV Ab test plus positive viral antigen or RNA test c. HIV-1 Ab avidity test consistent with recent infection, or d. Weakly reactive or equivocal 4th generation HIV Ab/Ag test.
• Medical Conditions Co-infection with HBV Current active Mycobacterium tuberculosis infection or known untreated latent infection. Significant cardiovascular disease or impaired cardiac function Active autoimmune disease requiring immunosuppressive treatment Prior solid organ or bone marrow transplant. History of malignant disease Pregnant or lactating women.

Lab values

• If any of the following laboratory exclusion criteria are met, then the site may have the participant retested. If a single value is within ±10% of the listed laboratory exclusion criterion value upon retest, and the value is considered not clinically significant by the physician Investigator, the participant may be considered for enrolment: a. Hemoglobin < 120 g/L for participants assigned male at birth; < 110 g/L for participants assigned female at birth b. Platelet count < 150 × 109/L c. Alanine aminotransferase (ALT) > 3 × ULN (upper limit of normal) d. eGFR(Foundation, 2009) < 60 mL/min/1.73 m2 (calculated using CKD-EPI equation, 2009; or measured)

Other

• Participation in other interventional studies
• Inability or unwillingness to adhere to safer sex practices during ART interruption.

• 18-65 years
• HLA-A*02:01-positive
• ≥ 50 kg
• Evidence of HIV-1 infection • On continuous ART for a minimum of 12 months and maximum of 15 years • Consistently undetectable plasma HIV RNA (< 50 copies/mL) throughout the 12-month period prior to screening • Current CD4+ T cell count > 450 cells/μL and CD4+ cells >15% total lymphocytes • CD4+ T cell nadir > 200 cells/μL
  • Contraception
  • Informed Consent