New antibody shot could help babies beat HIV – trial launches

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Infants from 1 to 365 days old at the time of enrolment. * Living with HIV-1, diagnosed with an approved assay detecting HIV nucleic acids in blood. * Weight \> 2.5 kg at enrolment. * ART-naïve or ≤ 30 days of triple ART at screening (not including prophylaxis in HIV-exposed). * Clinically stable and can be managed as outpatient (participants identified in-hospital can start the trial at their first routine visit). * Parent or legal guardian able to provide Informed consent (IC). Exclusion Criteria: * Participation in other concurrent research studies that, in the opinion of the principal investigator and central team, would interfere with the objectives of this study. * Previous receipt of bNAbs against HIV. * Serious Adverse Reactions (SARs) to the investigational medicinal product (IMP) or its components. * Intravenous (IV) immunoglobulins received within 90 days before IMP administration. * Any clinically significant acute or chronic illness or condition at screening that, in the opinion of the principal investigator/designee, renders the participant unfit to participate in the study or jeopardizes the safety or rights of the participant. Including, but not restricted to: * Evidence of active tuberculosis (TB) disease at the time of enrolment. * Life-threatening condition associated with a high risk of death within 30 days of enrolment, as determined by the study clinician. * Severe acute malnutrition with complications. * Severe neurological illness. * Hemodynamically significant severe congenital heart disease. * Active malignancies. * Life-threatening bleeding disorder. * Use of systemic immunosuppressive drugs within 30 days before first IMP administration. Not exclusionary: nasal steroid spray, inhaled steroids, topical steroids, a single course of oral/parenteral prednisone or equivalent at 2 mg/kg/day, and length of therapy \<14 days. * Unwillingness to have blood drawn * Unable to receive SC medications. * Chronic or recurrent urticaria or any other chronic dermatological condition that may be confused with local Adverse Reactions (ARs). Any social or medical condition in the caregivers that, in the judgement of the investigator, would interfere with protocol adherence, completion of the trial or assessment of safety.