you attend the clinic for the first time after being assigned to the study. the study staff explains the purpose, procedures, possible risks, and your rights. you sign a consent form indicating that you understand and agree to participate.

a series of medical evaluations are performed before any study medication is given. this includes physical examination, blood draws to measure viral load, cd4+ t cell count, and other laboratory tests. the results establish your starting point for later comparisons.

based on a computer-generated schedule, you are placed into one of the study arms. each arm receives a specific combination of infusions: the test arm receives the two antibodies 3bnc117-ls and 10-1074-ls together with a low dose of nivolumab; the comparator arm receives a placebo infusion of sodium chloride together with the same low dose of nivolumab.

you receive an intravenous infusion in a clinic setting. the infusion contains:

– 3bnc117-ls at a dose of 30 mg per kilogram of body weight, administered as a solution for injection.

– 10-1074-ls at a dose of 10 mg per kilogram of body weight, administered as a solution for injection.

– nivolumab at a dose of 1 mg per kilogram of body weight, given by intravenous infusion.

if you are in the comparator arm, the antibody infusions are replaced by a placebo infusion of sodium chloride 0.9% at 1 mg per kilogram, also given intravenously. the infusion is performed over a period of time determined by the study staff, and you are monitored for any immediate reactions.

additional infusions of the assigned study medication are given at later visits according to the study schedule. each infusion uses the same dose per kilogram as described for the first session. the exact timing of these visits is defined by the protocol and may occur every few weeks.

after the initial infusions, you stop taking your regular antiretroviral therapy (art) as instructed by the study. this period is called an art interruption. you are asked to attend frequent clinic visits for monitoring of viral load (the amount of hiv-1 RNA in the blood) and cd4+ t cell count.

you return to the clinic at specified weeks (for example, weeks 8, 14, 24, 36, and 60) or earlier if needed. at each visit, blood samples are collected to check viral load, cd4+ t cell count, and other safety laboratory values. any adverse events or side effects are recorded and evaluated.

if any of the following occurs, you will be instructed to restart antiretroviral therapy:

1) six consecutive weeks with viral load greater than 1,000 copies per milliliter,

2) confirmed viral load above 100,000 copies per milliliter,

3) cd4+ t cell count falling below 350 cells per cubic millimeter on two consecutive tests,

4) a request from you or a determination by the investigators that continuing the interruption poses an unacceptable risk.

restarting art is done promptly to protect your health.