More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents

Summary

The purpose of this study was to determine the dosage for oral cabotegravir (CAB) and long-acting cabotegravir (CAB LA) and long-acting rilpiverine (RPV LA) and evaluate the safety, acceptability, tolerability, and pharmacokinetics (PK) of oral CAB, CAB LA, and RPV LA in virologically suppressed children and adolescents living with HIV.

Timeline

Start

2019-04-03

Primary completion

2023-02-18

Completion

2025-04-22

Publications

• Results Gaur AH, Capparelli EV, Calabrese K, Baltrusaitis K, Marzinke MA, McCoig C, Van Solingen-Ristea RM, Mathiba SR, Adeyeye A, Moye JH, Heckman B, Lowenthal ED, Ward S, Milligan R, Samson P, Best BM, Harrington CM, Ford SL, Huang J, Crauwels H, Vandermeulen K, Agwu AL, Smith-Anderson C, Camacho-Gonzalez A, Ounchanum P, Kneebone JL, Townley E, Bolton Moore C; IMPAACT 2017 Collaborators; IMPAACT 2017 Team. Safety and pharmacokinetics of oral and long-acting injectable cabotegravir or long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study. Lancet HIV. 2024 Apr;11(4):e211-e221. doi: 10.1016/S2352-3018(23)00300-4.
• Results Lowenthal ED, Chapman J, Ohrenschall R, Calabrese K, Baltrusaitis K, Heckman B, Yin DE, Agwu AL, Harrington C, Van Solingen-Ristea RM, McCoig CC, Adeyeye A, Kneebone J, Chounta V, Smith-Anderson C, Camacho-Gonzalez A, D'Angelo J, Bearden A, Crauwels H, Huang J, Buisson S, Milligan R, Ward S, Bolton-Moore C, Gaur AH; IMPAACT 2017 Collaborators; IMPAACT 2017 Team. Acceptability and tolerability of long-acting injectable cabotegravir or rilpivirine in the first cohort of virologically suppressed adolescents living with HIV (IMPAACT 2017/MOCHA): a secondary analysis of a phase 1/2, multicentre, open-label, non-comparative dose-finding study. Lancet HIV. 2024 Apr;11(4):e222-e232. doi: 10.1016/S2352-3018(23)00301-6.
• Gaur AH, Baltrusaitis K, Capparelli EV, Moye JH, Yin DE, Masheto G, Buisson S, Harrington CM, Marzinke MA, Lowenthal ED, Scheckter R, Ace A, Ward S, Milligan R, Whitson K, Huang J, Cheung SYA, Best BM, Townley E, Roberts G, Kakuda TN, Birmingham E, Mathiba SR, Aurpibul L, Korutaro V, Smith C, Patel F, Moodley E, Bolton-Moore C; IMPAACT 2017 Collaborators; IMPAACT 2017 Team. Safety, antiviral activity, and pharmacokinetics of long-acting injectable cabotegravir-rilpivirine in virologically suppressed adolescents living with HIV-1 (IMPAACT 2017/MOCHA): 48-week results of a multinational, phase 1/2, single-arm study. Lancet HIV. 2026 Feb;13(2):e85-e94. doi: 10.1016/S2352-3018(25)00242-5. Epub 2026 Jan 14.
• Lowenthal ED, Chapman J, Baltrusaitis K, Kovic G, Merchant S, Branch K, Tsosie C, Vaca MZ, Heckman B, Van Solingen-Ristea RM, Harrington CM, Yin DE, Townley E, Whitton M, Agwu AL, Smith C, Paul ME, Violari A, Moodley E, Owor M, Chokephaibulkit K, Fry S, Jao J, Mitchell CD, Buisson S, Ace A, Kolobova I, Bolton-Moore C, Gaur AH; IMPAACT 2017 Collaborators; IMPAACT 2017 Team. Acceptability and tolerability of long-acting injectable cabotegravir-rilpivirine in adolescents with HIV-1 (IMPAACT 2017/MOCHA): 48-week results of a multicentre, open-label, non-comparative phase 1/2 trial. Lancet HIV. 2026 Feb;13(2):e95-e103. doi: 10.1016/S2352-3018(25)00241-3. Epub 2026 Jan 14.
• Okesanya OJ, Ayeni RA, Amadin P, Ngwoke I, Amisu BO, Ukoaka BM, Ahmed MM, Oso TA, Musa SS, Lucero-Prisno DE. Advances in HIV Treatment and Vaccine Development: Emerging Therapies and Breakthrough Strategies for Long-Term Control. AIDS Res Treat. 2025 Jul 4;2025:6829446. doi: 10.1155/arat/6829446. eCollection 2025.
• Moore CB, Baltrusaitis K, Best BM, Moye JH, Townley E, Violari A, Heckman B, Buisson S, Van Solingen-Ristea RM, Capparelli EV, Marzinke MA, Lowenthal ED, Ward S, Krotje C, Milligan R, Agwu AL, Huang J, Cheung SYA, McCoig C, Yin DE, Roberts G, Crauwels H, Van Eygen V, Zabih S, Masheto G, Ounchanum P, Aurpibul L, Korutaro V, Gaur AH; IMPAACT 2017 Collaborators for the IMPAACT 2017 Team. Safety of combined long-acting injectable cabotegravir and long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study. Lancet HIV. 2025 Mar;12(3):e191-e200. doi: 10.1016/S2352-3018(24)00344-8.

Drugs

Indications