Table 1.

Trials of Long-Acting Agents in Newborns, Infants, Children, and Adolescents^a

Agent	Study	Indication	Objectives	Population	Sample Size	Status
	Broadly neutralizing antibodies (bNABs)
SC VRC01, SC VRC01LS, VRC07-523LS	IMPAACT 1112	Prevention and Treatment	Phase I study to determine safety and Pharmacokinetics (PK) of each agent administered SC in infancy	HIV-exposed infants	79	Complete
SC VRC07-523LS + CAP256V2LS	PedMAB	Prevention	Phase I/II study, dose finding, PK and safey	HIV-exposed newborns	…	Enrolling
SC VRC07-523LS	SAMBUELA	Prevention	Phase II PK and safety in breastfed infants	HIV-exposed, unexposed, and infected newborns	128	In development
SC VRC01LS	EDCTP Neo bnAb Trial	Prevention	4 doses from birth to 36 w	HIV-exposed newborns	2000	In development
SC VRCO1	IMPAACT 2008	Cure	Phase I/II RCT of VRC01 with ART to promote clearance of HIV-infected cells in infants with HIV	<12 w, living with HIV	61	Complete
IV VRC01LS and 10-1074	Dual bNAb Treatment in Children: Tatelo Study	Treatment	Safety, PK, dosing, and antiviral efficacy of maintenance VRC01LS and 10-1074 immunotherapy on viral suppression in early treated children	2–5 y, living with HIV	30	Ongoing
CAP256-V2LS, VRC07-523LS and PGT121.414LS	ENABLE	Treatment	Safety, PK, reduction in viral load and reservoir size, increase in HIV-specific immune response	28–180 d, 2–7 y	20	In development
	Antiretroviral Agents		…	…	…	…
IM CAB/RPV	IMPAACT 2017/MOCHA	HIV Treatment	Phase I/I study of safety, acceptability, tolerability, and PK of CAB/RPV in virologically suppressed children and adolescents	12≤18 y, youth living with HIV	155	Actively enrolling
IM CAB/RPV	IMPAACT 2036/CRAYON	HIV Treatment	Phase I/II study of safety, tolerability, PK, and antiviral activity of CAB/RPV in virologically suppressed children	>2≤12 y and weighing >10 kg and <50 kg, children living with HIV	TBD	In development
IM CAB/RPV	LATA	HIV Treatment	Open label, non-inferiority study of virologically suppressed participants on first-line ART; primary endpoint: proportion with confirmed virological rebound, HIV-RBA ≥50 copies/mL	12–19 y, youth living with HIV	230/arm: CAB/RPV vs DTG/3TC/TDF	Open to enrollment, fall 2022
IM CAB/RPV	IMPAACT 2040/CREATE	HIV Treatment	Phase I/II PK and safety of IM CAB/RPV in pregnancy and postpartum; wash-out PK in exposed neonates	Pregnant people and their newborns through	45 mother/baby pairs	In development

Abbreviations: ART, antiretroviral therapy; CAB/RPV, cabotegravir/rilpivirine; CRAYON, Cabotegravir and Rilpivirine Long-Acting Injections in Young Children; CREATE, Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy; EDCTP, European and Developing Countries Clinical Trials Partnership; ENABLE, Early Neutralizing Antibodies children in Earth cohort; HIV, human immunodeficiency virus; IMPAACT, International Maternal Pediatric Adolescent AIDS Clinical Trials Network; LATA, Long Acting Treatment for Adolescents; MOCHA, More Options for Children and Adolescents; PK, pharmacokinetic; RCT, randomly controlled trial; RPV, Rilpivirine.

^aGiven the dynamic scientific landscape, emerging studies may not be included in this table.