A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIV

Inclusion Criteria

• •Part A:
• •Are HIV-1 and HIV-2 negative at Visit 0.
• •Starting at Visit 0 and continuously until the last planned visit in this study are individuals who:
• •1. Are assessed by the investigator as having a low likelihood of acquiring HIV and are committed to avoiding behaviors associated with a higher likelihood of acquiring HIV until the End of Study Visit.
• •2. Agree to discuss HIV disease risks;
• •3. Agree to HIV acquisition risk reduction counseling;
• •Part B:
• •Are HIV-1 positive and HIV-2 negative at Visit 0.
• •Individuals who at Visit 0:
• •1. Are cART-naïve individuals who were diagnosed with HIV-1 infection ≤12 months prior to screening, OR are individuals who have discontinued cART and who were diagnosed with HIV-1 infection ≤12 months prior to screening or ≤18 months if this is found to be acceptable after discussion on a case-by-case basis with the sponsor's medical monitor.
• •2. If cART-experienced, have discontinued cART for at least 4 weeks before screening (if the individual was taking long-acting antiretroviral therapy \[ART\]), see the following bullet). For individuals who have discontinued cART: Are able to comply with study procedures and assessments in the investigator's judgment.
• •3. Have never received lenacapavir or ibalizumab or fostemsavir, and have not received other long-acting ARTs in the last 6 months (i.e., intramuscular cabotegravir, cabotegravir-rilpivirine).
• •4. Have a CD4+ T cell count of ≥500 cells/µL and plasma HIV-1 RNA levels between 5,000-100,000 copies/mL at screening.
• •5. Are willing to initiate cART at a protocol-defined timepoint (56 days post-dose, or earlier if meeting early cART start criteria or at investigator's discretion).
• •6. Are willing to undergo HIV transmission risk reduction counseling and to maintain low-risk behavior to protect their partners.