A randomized placebo-controlled 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 (LONGBNAB)

About the Study

The purpose of this research study is to evaluate whether three doses of the two study drugs being tested, 3BN117-LS and 10-1074-LS, are safe and tolerable. This study will also evaluate if the study drugs change the numbers of blood cells that are infected with HIV while you are on antiretroviral therapy (ART). This pool of blood cells that contain dormant HIV is referred to as the persistent viral reservoir.

What does the study involve?

Study participants will receive three doses of the two study antibodies or placebo (normal saline) at random as intravenous infusions through a needle inserted in a vein on your arm. You will have a 1 in 2 chance of receiving the study antibodies. Participants will return to the study site for follow up visits over the course of about 20 months. We will collect blood samples during each follow up visit (about 1 to 10 tablespoons of blood each time). Participants will also undergo three to five leukapheresis procedures. Three of these procedures will be before each dose of the study antibodies, and two more will be on study weeks 60 and 80. Leukapheresis is a several-hours-long procedure in which blood is collected from a vein in one of your arms, processed through an attached machine, and then returned to you through a vein in the opposite arm. The study will also include studies of the expression of your genes.

Is compensation provided?

There is no cost, and subjects will be compensated.

Who Can Participate

You can participate if:

• You are age 18-70 and living with HIV
• You have a current CD4 t-cell count >350
• You have had a HIV viral load of <50 for at least the past 24 months
• You have been on HIV medication consistently for at least the past two years
• You do not have difficulty having blood drawn
• You do not currently have any form of cancer, and you have not had chemotherapy in the past six months
• You are aware that getting the study drug or placebo is determined at random
• If female, you are not pregnant, breastfeeding, or trying to become pregnant
• All participants who engage in sexual activity that could lead to pregnancy must agree to use condoms during the study period
• You can travel to the NIH in Bethesda, Maryland, for study visits

Visit ClinicalTrials.gov for details.