A5417: Randomized, Double-Blind, Placebo-Controlled Study of the Combination of two Long-Acting Broadly Neutralizing Antibodies at ART Initiation in Adults Living with HIV-1 in sub-Saharan Africa

This study enrolls people living with HIV in sub-Saharan Africa at the time that they are about to start antiretroviral therapy (ART). They will be assigned to receive either two long-acting study medications called “monoclonal antibodies” or placebo (normal saline) when they start ART. An antibody is a substance that the body makes in response to an infection. The antibodies in this study attach to HIV and can block HIV from attacking cells in the body and from spreading to other parts of the body. These study antibodies are being developed to potentially treat and prevent HIV.

• To see if it is safe to give people monoclonal antibodies when administered at the time of starting ART.
• To see if people who receive these antibodies can control HIV without continuing their ART forever.

• Have HIV and are between the ages of 18 and 60 years.
• Have HIV viral load greater than 1000 copies/mL.
• Have a CD4+ cell count greater than 200.
• Have never used ART (prior use of PrEP to prevent HIV is allowed).

Participants will be randomized 2:1 to receive:

• Monoclonal antibodies (3BNC117-LS plus 10-1074-LS) or placebo (sterile normal saline) by infusions in the arms.
• ART (regular drugs to control HIV) will follow national guidelines.

After about 1.5 years, participants will stop ART and be closely monitored to better understand the effects of the antibodies on HIV.

Monoclonal antibodies (3BNC117-LS plus 10-1074-LS) will be provided by the study. Integrase inhibitor-base ART regimen will not be provided by the study.

Up to 180 weeks.