A Study to Evaluate the Safety and Effects of Repeated Doses of 3BNC117-LS and 10-1074-LS on Persistent Viral Reservoirs in People Living With HIV and on Suppressive Antiretroviral Therapy

Eligibility Criteria

• 1. Ability to provide informed consent;
• 2. Stated willingness to comply with all study procedures and availability for the duration of the study;
• 3. Adult persons of any sex or gender, aged 18 years to 70;
• 4. Confirmed HIV-1 infection and clinically stable;
• 5. On antiretroviral therapy with plasma HIV-1 RNA levels of \< 50 copies/mL and no reported interruption of ART for 7 consecutive days or longer for at least 96 weeks. NOTE: At least two viral load (VL) measurements within 48 weeks prior to the screening visit must be available for review. A single plasma HIV-1 RNA \> 50 copies/mL but \< 200 copies/mL over 48 weeks that is followed by an HIV-1 RNA \< 50 copies/mL is permitted;
• 6. Current CD4+ T cell counts \> 300 cells/mcL;
• 7. For participants who can become pregnant (i.e., participants who have not been postmenopausal for at least 24 consecutive months, who have had menses within the preceding 24 months, or who have not undergone surgical sterilization, specifically hysterectomy and/or bilateral oophorectomy), must have a negative pregnancy test at screening and within 48 hours prior to day 0; NOTE: Participant-reported history is acceptable as documentation of hysterectomy and bilateral oophorectomy, tubal ligation, tubal micro-inserts, and vasectomy.
• 8. Participants who can become pregnant must agree to use adequate measures to prevent pregnancy. This includes the use an effective method of contraception for the study duration. Contraception must be used from 10 days prior to the first dose of the investigational products (IPs), while receiving the IPs and during study follow up. Acceptable methods of contraception include:
• * Contraceptive subdermal implant
• * Intrauterine device or intrauterine system
• * Combined estrogen and progestogen oral contraceptive
• * Injectable progestogen
• * Contraceptive vaginal ring
• * Percutaneous contraceptive patches
• 9. Participants who can impregnate a partner and who are engaging in sexual activity that could lead to pregnancy must agree to use condoms from 10 days prior to the first dose of the IPs, while receiving the IPs and during study follow up to avoid impregnating a partner who can get pregnant.
• 1. History of AIDS-defining illness within 3 years prior to enrollment;
• 2. History of systemic corticosteroids (e.g., an equivalent dose of prednisone of \> 20 mg daily for \>14 days), immunosuppressive anti-cancer, interleukins, systemic interferons, systemic chemotherapy or other medications considered significant by the trial physician within the last 6 months;
• 3. Any clinically significant acute or chronic medical condition (e.g. such as autoimmune diseases, cirrhosis, active malignancy that may require systemic chemotherapy or radiation therapy), other than HIV infection, that in the opinion of the investigator would preclude participation;
• 4. Hepatitis B or C infection as indicated by the presence of Hepatitis B surface antigen (HBsAg) or hepatitis C virus RNA (HCV-RNA) in blood. NOTE: Participants with a positive test for HCV antibody and a negative test for HCV RNA are eligible;
• 5. Participants with known hypersensitivity to any constituent of the investigational products;
• 6. Pregnancy or lactation;
• 7. ART initiated during acute infection (defined as p24, HIV nucleic acid amplification technique \[NAAT\], or HIV RNA PCR positive, and negative or indeterminate HIV antibody testing);
• 8. Laboratory abnormalities in the parameters listed below:
• * Absolute neutrophil count \< 1,000 cells/microliter
• * Hemoglobin \< 10 gm/dL
• * Platelet count \< 100,000 cells/microliter
• * ALT \> 1.5 x ULN
• * AST \> 1.5 x ULN
• * Total bilirubin \> 1.5 x ULN
• * Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m\^2
• 9. Any history of receipt of HIV-1 mAb therapy or HIV vaccine;
• 10. Participation in any clinical study of an investigational product within 12 weeks prior to study entry (day 0) or expected participation in such a study during this study;
• 11. Any approved or experimental non-HIV vaccination (e.g., SARS-CoV-2, hepatitis B, influenza, pneumococcal polysaccharide) received within 2 weeks prior to study enrollment (day 0);
• 12. Inability to undergo leukapheresis due to poor venous access or other medical conditions;
• 13. Active drug or alcohol use or any other pattern of behavior that, in the opinion of the investigator, would interfere with adherence to study requirements.