Table 1.

Clinical trials evaluating intramuscular long-acting cabotegravir (CAB LA) and/or long-acting rilpivirine (RPV LA) for treatment of HIV

Study	Phase	Population	Design	Duration	Status	Results	Sponsor(s)	Reference
LATTE NCT01641809	IIb	Treatment-naïve Adults N=234	Daily oral CAB (escalating dose) + oral RPV vs. 2 NRTI + EFV	96 weeks	Active, not recruiting	68%-84% in oral CAB arms vs. 63% in EFV arms achieved HIV VL <50 copies/mL	ViiV/Janssen	35
LATTE-2 NCT02120352	IIb	Treatment-naïve Adults N=286	Induction with oral ABC/3TC + oral CAB followed by IM CAB LA + RVP LA Q4W or Q8W vs. continuation of oral ART	96 weeks	Active, not recruiting	87% (Q4W) and 94% (Q8W) in the LA ART vs. 84% in oral ART achieved HIV VL <50 copies/mL	ViiV/Janssen	36
POLAR NCT03639311	IIb	LATTE Participants N=100	IM CAB LA + RPV LA Q8W vs. daily oral DTG + RPV	52 weeks	Recruiting	N/A	ViiV/Janssen	N/A
FLAIR NCT02938520	III	Treatment-naïve Adults N=629	Induction with oral daily ABC/3TC/DTG then randomized to IM CAB LA + RPV LA Q4W vs. continuation of oral ART	96 weeks (extension phase available)	Active, not recruiting	IM CAB LA + RPV LA non-inferior to continuation of oral daily ABC/3TC/DTG at 48 weeks	ViiV/Janssen	37
ATLAS NCT02951052	III	Virologically-suppressed adults N=616	Continuation of oral daily ART vs. IM CAB LA + RPV LA Q4W	96 weeks (extension phase or transition to ATLAS-2M)	Active, not recruiting	IM CAB LA + RPV LA non-inferior to continuation of oral daily SOC ART at 48 weeks	ViiV/Janssen	38
ATLAS-2M NCT03299049	IIIb	Virologically-suppressed adults N=1,045	Randomization from oral SOC to IM CAB LA+ RPV LA Q4W vs Q8W OR from IM CAB LA + RPV LA Q4W to continue Q4W vs. Q8W	48 weeks	Active, not recruiting	IM CAB LA + RPV LA Q8W non-inferior to Q4W IM CAB LA + RPV LA	ViiV/Janssen	N/A
LATITUDE NCT03635788	III	Sub optimally-adherent adults N=350	Induction with daily oral SOC ART using conditional economic incentives, then randomization to continuation of oral SOC (without incentives) vs. IM CAB LA + RPV Q4W	180 weeks	Recruiting	N/A	NIH/NIAID	N/A
MOCHA NCT03497676	I/II	Virologically-suppressed children and adolescents N=155	Lead-in phase with daily oral CAB, oral RPV or oral CAB + RPV followed by IM CAB LA Q4W, IM RPV LA Q4W or IM CAB LA + RPV LA Q4W	64 to144 weeks	Recruiting	N/A	NIH/NIAID	N/A
A5357 NCT03739996	II	Virologically-suppressed adults N=74	Switch from daily oral SOC ART to 2 NRTI + daily oral CAB followed by IM LA CAB Q4W + VRC01LS Q12W	96 weeks	Recruiting	N/A	NIH/NIAID	N/A

IM: intramuscular; CAB: cabotegravir; RPV: rilpivirine; NRTI: nucleos(t)ide analog reverse transcriptase inhibitor; HIV VL: HIV viral load; EFV: efavirenz; ABC: abacavir; 3TC: lamivudine; DTG: dolutegravir; SOC: standard of care; NIH: National Institutes of Health; NIAID: National Institute of Allergy and Infectious Diseases; N/A: not available.