Phase 12 Study of Three Broadly Neutralizing Antibodies or Treatment Pause to Control HIV in Early-Treated Children and Young Adults in Botswana

What this Trial Is About

Researchers are investigating new ways to improve HIV treatment and explore potential cures in children who started treatment early. The study focuses on testing a combination of three broadly neutralizing antibodies bNAbs or a planned break from antiretroviral therapy ART to see how these approaches affect the viral reservoir, immune system function, and the ability to keep the virus under control in children living with HIV in Botswana. The study includes several steps with different treatment approaches. Initially, children receive one of the three bNAbs alone to assess safety, followed by a rotating schedule of all three antibodies alongside their regular ART. Later steps involve stopping ART while continuing bNAbs, or stopping both ART and antibody treatments to observe effects. The study measures how long the virus remains suppressed and monitors immune health during these phases. Participants will have regular visits for safety checks, blood tests to measure viral levels and immune cell counts, and pharmacokinetic assessments to understand how the antibodies behave in the body. Researchers will also monitor the size of the viral reservoir and time to viral rebound if it occurs. Study participation includes up to 48 weeks of treatment and follow-up, with careful monitoring to ensure participant safety throughout.

The Tatelo Plus Study