National Institute of Allergy and Infectious Diseases (NIAID)
The study will explore the effects of early intensive antiretroviral therapy (ART) with or without a broadly neutralizing antibody (bNAb) on achieving HIV remission (HIV RNA below the limit of detection of the assay) among infants living with HIV.
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 infants living with HIV. The study will enroll two cohorts. Cohort 1 will include infants born to a mother with presumed or confirmed HIV infection who received no or very limited antiretrovirals during pregnancy. Cohort 2 will include infants with at least one positive HIV nucleic acid test result from a sample collected within 48 hours of birth who initiated a qualifying ART regimen within 48 hours of birth.…
Maternal Inclusion Criteria 1. Presumed or confirmed maternal HIV infection: * Mothers will be eligible to enroll with EITHER: * Presumed HIV infection defined as at least one positive rapid HIV antibody-based test result from a sample collected in the peripartum period. Presumed infection must be confirmed within 10 business days of enrollment OR * Confirmed HIV infection defined as positive results from two samples collected at different timepoints 2. Willing and able to provide written informed consent for participation of herself and her infant. The mother must be of legal…
Chosen by the site investigator and dosed according to World Health Organization (WHO) or individual country or local standard guidelines.
Administered orally. Dosed according to study step/participant's age/participant's weight.
Administered orally. Dosed according to study step and participant's age.
Administered orally. Dosed according to study step and participant's age.
40 mg/kg administered subcutaneously.
Dosed according to study step/participant's age/participant's weight
40 mg/kg administered subcutaneously.