Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Females

Phase 2 Completed 55 enrolled National Institute of Allergy and Infectious Diseases (NIAID) Bill and Melinda Gates Foundation · collab ViiV Healthcare · collab

NaSingle-groupOpen-labelPrevention

Summary

This study will establish the minimum safety, tolerability and acceptability data needed to support the use of cabotegravir long-acting injection (CAB LA) in an adolescent population, potentially transforming the field of HIV prevention for young people.

Timeline

Start: 2020-11-04
Primary completion: 2023-01-10
Completion: 2023-01-10

Publications

Stranix-Chibanda L, Hamilton EL, Ngo J, Jiao Y, Hanscom B, Choudhury RP, Agyei Y, Piwowar-Manning E, Marzinke M, Delany-Moretlwe S, Mgodi N, Siziba B, Naidoo I, Gati Mirembe B, Kamira B, McCoig C, Adeyeye A, Spiegel HML, Hosek S; HPTN 084-01 Protocol Team. Safety, tolerability, and acceptability of long-acting injectable cabotegravir for HIV prevention in cisgender female adolescents (HPTN 084-01): a single-arm, open-label, phase 2b trial. Lancet HIV. 2025 Apr;12(4):e252-e260. doi: 10.1016/S2352-3018(24)00310-2. Epub 2025 Mar 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cabotegravir	Small molecule	30 mg	Oral
Subject	Cabotegravir	Small molecule	600 mg	Oral
Background	Tenofovir disoproxil fumarate	Small molecule	300 mg	Oral
Background	emtricitabine	Other / unclassified	200 mg	Oral

Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Females

Summary

Timeline

Publications

Drugs

Indications