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IMPAACT 2042 / Tatelo Plus

Phase I/II Trial to Evaluate the Impact of Three Broadly Neutralizing Antibodies or Analytic Treatment Interruption on Viral Reservoir, Immune Function, and Maintenance of HIV Suppression in Early-Treated Children in Botswana

Study Status

Open to Accrual

DAIDS Number

39076

IND Number

171,721

Clinical Trials Link

Summary

IMPAACT 2042, also known as the Tatelo-Plus study, is designed to evaluate the viral and immune response, including maintenance of HIV suppression, to a combination of three anti-HIV broadly neutralizing antibodies (bNAbs) among up to 41 children and youth (24 months to 25 years of age) living with HIV who began receiving antiretroviral treatment (ART) soon after birth and have been followed in existing cohorts at the Botswana Harvard Health Partnership. These responses are also evaluated when ART is stopped, referred to as analytic treatment interruption (ATI), among study participants who meet specific criteria. The overall purpose of this Phase I/II, open-label study is to advance pediatric HIV treatment and remission/cure research by evaluating this combination of bNAbs, including safety and pharmacokinetics, and treatment interruption in participants whose HIV is fully suppressed. The bNAbs to be evaluated are PGDM1400LS, PGT121.414.LS, and VRC07-523LS.

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