3BNC117-LS-J / Rockefeller University, IAVI - LARVOL DELTA

PAUSE: Pausing Antiretroviral Treatment Under Structured Evaluation (clinicaltrials.gov) - P1 | N=32 | Active, not recruiting | Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | Recruiting ➔ Active, not recruiting | N=48 ➔ 32

Enrollment change • Enrollment closed • Human Immunodeficiency Virus • Infectious Disease • CD4

Safety and pharmacokinetic profile of a combination of two HIV broadly neutralizing antibodies, 3BNC117-LS-J and 10-1074-LS-J, in healthy American and African adults (IAS-HIV 2025) - "Both 3BNC117-LS-J and 10-1074-LS-J have demonstrated an acceptable safety profile and there were no significant differences between administered dose levels, combinations and administration routes. Region of study participants (US vs Africa) was a major factor influencing the PK profile."

Clinical • PK/PD data • Human Immunodeficiency Virus • Infectious Disease • Pain • CD4

Safety and Pharmacokinetics of the Combination Broadly Neutralizing Antibodies, 3BNC117-LS-J and 10-1074-LS-J, in Healthy American and African Adults (clinicaltrials.gov) - P1/2 | N=225 | Completed | Sponsor: International AIDS Vaccine Initiative | Active, not recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease

PAUSE: Pausing Antiretroviral Treatment Under Structured Evaluation (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | Trial primary completion date: Jun 2025 ➔ Apr 2026

Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • CD4

PAUSE: Pausing Antiretroviral Treatment Under Structured Evaluation (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | Not yet recruiting ➔ Recruiting

Enrollment open • Immunomodulating • Human Immunodeficiency Virus • Infectious Disease • CD4

PAUSE: Pausing Antiretroviral Treatment Under Structured Evaluation (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: AIDS Clinical Trials Group

Immunomodulating • New P1 trial • Human Immunodeficiency Virus • Infectious Disease • CD4

Safety and Pharmacokinetics of the Combination Broadly Neutralizing Antibodies, 3BNC117-LS-J and 10-1074-LS-J, in Healthy American and African Adults (clinicaltrials.gov) - P1/2 | N=225 | Active, not recruiting | Sponsor: International AIDS Vaccine Initiative | Trial completion date: Sep 2022 ➔ Sep 2023 | Trial primary completion date: Mar 2022 ➔ Sep 2023

Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

Safety and Pharmacokinetics of the Combination Broadly Neutralizing Antibodies, 3BNC117-LS-J and 10-1074-LS-J, in Healthy American and African Adults (clinicaltrials.gov) - P1/2 | N=225 | Active, not recruiting | Sponsor: International AIDS Vaccine Initiative | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2021 ➔ Sep 2022 | Trial primary completion date: Dec 2021 ➔ Mar 2022

Enrollment closed • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease