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

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.

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 age or circumstance to provide independent informed consent as determined by site standard operating procedures (SOPs) and consistent with IRB/EC policies and procedures. Otherwise, informed consent must be obtained from a legal guardian and the mother must provide written assent. 3. Was not previously enrolled in this study with another infant. 4. Did not receive ARVs during the current pregnancy. 5. Infant is eligible per inclusion criteria. Infant Inclusion Criteria for Step 1 1. Less than or equal to 48 hours of age. 2. Greater than or equal to 37 weeks gestational age at birth (assessment of gestational age will be based on the best clinical estimate determined by date of last menstrual period, antenatal ultrasound, fundal height, or Ballard Score). 3. Greater than or equal to 2 kilograms (kg) at birth. 4. Able to take ARVs by mouth, nasogastric tube, or gastrostomy tube. 5. Has no clinically significant diseases (other than HIV infection) or clinically significant findings during review of medical history or physical examination prior to entry that, in the site investigator's opinion, would interfere with study participation or interpretation. 6. Mother is eligible per inclusion criteria. Infant Inclusion Criteria for Step 2 1. Enrolled in Step 1. 2. Confirmed in utero HIV infection. 3. Able to take ARVs by mouth, nasogastric tube, or gastrostomy tube. 4. Has no clinically significant diseases (other than HIV infection) or clinically significant findings during review of medical history or physical examination prior to entry that, in the site investigator's opinion, would interfere with study participation or interpretation. 5. Mother (or legal guardian if applicable) is willing and able to provide written informed consent for child's participation in Step 2. Infant Inclusion Criteria for Step 3 1. Enrolled in Step 2. 2. Has reached Step 2 Week 96. 3. Has the following results based on testing: * No confirmed plasma HIV RNA ≥200 copies/mL at Step 2 Week 24 and up to but excluding Step 2 Week 48. * No plasma HIV RNA detected at Step 2 Week 48 and thereafter, with two possible exceptions * (i) First possible exception: If HIV RNA is detected at or after Step 2 Week 48 with a result \