Last updated on November 2019

Very Early Intensive Treatment of HIV-Infected Infants to Achieve HIV Remission


Brief description of study

The study will explore the effects of early intensive antiretroviral therapy (ART) on achieving HIV remission (HIV RNA below the limit of detection of the assay) among HIV-infected infants.

Detailed Study Description

The purpose of this study is to explore the effects of early intensive antiretroviral therapy (ART) on achieving HIV remission (HIV RNA below the limit of detection of the assay) among HIV-infected infants.

The study will enroll two cohorts. Cohort 1 will include infants at high risk for in utero HIV infection. Cohort 2 will include in utero HIV-infected, ART-started infants.

Three early intensive therapy regimens will be assessed. Regimen 1L will include 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus nevirapine (NVP) plus lopinavir/ritonavir (LPV/r). Regimen 2R will include 2 NRTIs plus NVP plus raltegravir (RAL). Regimen 2RV will include 2 NRTIs plus NVP plus RAL plus VRC01 monoclonal antibody.

The study will be conducted in four steps. In Step 1, Cohort 1 infants will be enrolled for evaluation of HIV infection and initiation of early intensive therapy within 48 hours of birth. Infants in whom in utero HIV infection is excluded will switch from the study regimen to standard perinatal prophylaxis per local guidelines within two weeks; these infants will continue in Step 1 safety monitoring for two additional weeks, undergo final HIV testing at approximately 12 weeks of age, and then exit the study. Infants in whom in utero HIV infection is confirmed will enter Step 2 at least two weeks after enrollment in Step 1.

In Step 2, Cohort 1 infants identified with in utero HIV infection and Cohort 2 infants will receive the study regimen for up to 192 weeks. Beginning at Step 2 Week 84, children who achieved HIV RNA suppression by Week 24, and maintained suppression thereafter, with no HIV RNA detected at or after Week 48, will be evaluated for possible treatment cessation.

In Step 3, children in Step 2 who meet criteria for treatment cessation will stop ART, and be closely monitored for viral rebound for up to five years.

In Step 4, children who experience viral rebound in Step 3 or meet other Step 4 inclusion criteria will re-initiate ART, and be closely monitored for viral re-suppression on ART until five years of age or six months after re-suppression, whichever is later.

HIV-uninfected infants will be followed for 12 weeks. HIV-infected infants will be followed for up to 192 weeks in Step 2 (on ART); those entering Step 3 will be followed for primary endpoint ascertainment at 48 weeks and for up to a total of five years (off ART) in this step.

Clinical Study Identifier: NCT02140255

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