Early Intensive Antiretroviral Therapy With or Without Broadly Neutralizing Antibodies to Achieve HIV Remission in Infants

What this Trial Is About

Researchers are exploring the effects of early intensive antiretroviral therapy ART, with or without broadly neutralizing antibodies bNAbs, on achieving HIV remission in infants living with HIV. The study includes two groups infants born to mothers with presumed or confirmed HIV infection who received little or no antiretrovirals during pregnancy, and infants diagnosed with HIV within 48 hours of birth who start ART early. This study is a Phase III proof of concept trial aiming to evaluate treatment strategies that may reduce HIV RNA to undetectable levels in infants. The trial assesses seven different intensive therapy regimens combining two nucleoside reverse transcriptase inhibitors NRTIs with other drugs such as nevirapine NVP, lopinavirritonavir LPVr, raltegravir RAL, dolutegravir DTG, and monoclonal antibodies like VRC01 and VRC07-523LS. Participants receive these regimens based on their cohort and specific treatment plan. The study is conducted in four steps initial evaluation and treatment initiation within 48 hours of birth, ongoing treatment for up to 192 weeks with assessments for viral suppression, possible analytic treatment interruption with close monitoring for viral rebound, and re-initiation of ART with monitoring until five years of age or six months after viral suppression. Participants are closely monitored throughout the study with HIV testing, safety assessments, and adherence evaluations. Researchers measure outcomes such as the number of participants achieving HIV remission by Week 48, viral suppression rates, eligibility and response to treatment interruption, and adverse events related to the study treatments. Safety monitoring continues during treatment interruption and after re-treatment. The total participation duration can extend up to five years to assess long-term effects and viral control.

Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission