Browsing by Author "McCoig C"

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    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.
    (2024-Apr) 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; Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.; Janssen Research and Development, Beerse, Belgium.; University of California San Diego, La Jolla, CA, USA.; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Bethesda, MD, USA.; Emory University School of Medicine-Children's Healthcare of Atlanta, Atlanta, GA, USA.; Frontier Science Foundation, Boston, MA, USA.; ViiV Healthcare, Madrid, Spain.; ViiV Healthcare, ResearchTriangle Park, NC, USA.; Baragwanath Academic Hospital, Johannesburg, South Africa.; FHI 360, Durham, NC, USA.; Frontier Science Foundation, Amherst, NY, USA.; St Jude Children's Research Hospital, Memphis, TN, USA. Electronic address: aditya.gaur@stjude.org.; Johns Hopkins University School of Medicine, Baltimore, MD, USA.; University of Colorado School of Medicine, Aurora, CO, USA.; Chiangrai Prachanukroh Hospital, Chiang Rai, Thailand.; University of Pennsylvania Perelman School of Medicine, Children's Hospital of Philadelphia, Philadelphia, PA, USA.; GlaxoSmithKline, Mississauga, ON, Canada.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia; University of Alabama, Birmingham, AL, USA.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    BACKGROUND: Combined intramuscular long-acting cabotegravir and long-acting rilpivirine constitute the first long-acting combination antiretroviral therapy (ART) regimen approved for adults with HIV. The goal of the IMPAACT 2017 study (MOCHA [More Options for Children and Adolescents]) was to assess the safety and pharmacokinetics of these drugs in adolescents. METHODS: In this phase 1/2, multicentre, open-label, non-comparative, dose-finding study, virologically suppressed adolescents (aged 12-17 years; weight ≥35 kg; BMI ≤31·5 kg/m FINDINGS: Between March 19, 2019, and Nov 25, 2021, 55 participants were enrolled: 30 in cohort 1C and 25 in cohort 1R. At week 16, 28 (97%, 95% CI 82-100) of the 29 dose-evaluable participants in cohort 1C and 21 (91%; 72-99) of the 23 dose-evaluable participants in cohort 1R had reported at least one adverse event, with the most common being injection-site pain (nine [31%] in cohort 1C; nine [39%] in cohort 1R; none were severe). One (4%, 95% CI 0-22) participant in cohort 1R had an adverse event of grade 3 or higher, leading to treatment discontinuation, which was defined as acute rilpivirine-related allergic reaction (self-limiting generalised urticaria) after the first oral dose. No deaths or life-threatening events occurred. In cohort 1C, the week 2 median cabotegravir AUC INTERPRETATION: Study data support using long-acting cabotegravir or long-acting rilpivirine, given every 4 weeks or 8 weeks, per the adult dosing regimens, in virologically suppressed adolescents aged 12 years and older and weighing at least 35 kg. FUNDING: The National Institutes of Health and ViiV Healthcare.
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    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.
    (2025-Mar) 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; Janssen Research and Development, Beerse, Belgium.; Baylor College of Medicine Children's Foundation Uganda, Kampala, Uganda.; University of California San Diego, La Jolla, CA, USA.; Certara, Radnor, PA, USA; GlaxoSmithKline, Collegeville, PA, USA.; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.; Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.; ViiV Healthcare, Madrid, Spain.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia; University of Alabama at Birmingham, Birmingham, AL, USA. Electronic address: carolyn.bolton@cidrz.org.; University of California Los Angeles, Los Angeles, CA, USA.; St Jude Children's Research Hospital, Memphis, TN, USA.; Frontier Science Foundation, Amherst, NY, USA.; FHI 360, Durham, NC, USA.; Frontier Science Foundation, Brookline, MA, USA.; Botswana Harvard Health Partnership, Gaborone, Botswana.; Johns Hopkins University School of Medicine, Baltimore, MD, USA.; Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, Thailand.; Chiangrai Prachanukroh Hospital, Chiang Rai, Thailand.; University of Pennsylvania Perelman School of Medicine, Children's Hospital of Philadelphia, Philadelphia, PA, USA.; GlaxoSmithKline, Mississauga, ON, Canada.; Center for Biostatistics in AIDS Research, Harvard T H Chan School of Public Health, Boston, MA, USA.; Perinatal HIV Research Unit, University of Witwatersrand, Johannesburg, South Africa.; SMG Pharma Safety GlaxoSmithKline, Middlesex, UK.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    BACKGROUND: Long-acting cabotegravir and long-acting rilpivirine constitute a completely intramuscular antiretroviral therapy (ART) regimen for adults with HIV. We aimed to assess the safety, antiviral activity, and pharmacokinetics of oral cabotegravir and rilpivirine followed by a combination of long-acting cabotegravir and long-acting rilpivirine in virologically suppressed adolescents with HIV. METHODS: The IMPAACT 2017/MOCHA study is a phase 1/2, multicentre, open-label, non-comparative, dose-finding trial being conducted at 18 sites across Botswana, South Africa, Thailand, Uganda, and the USA. In cohort 2 of this study, adolescents (aged 12-18 years; weight ≥35 kg) with HIV and no serious comorbidities who were receiving stable combination ART with confirmed virological suppression and had either previously enrolled in the first cohort or had not previously participated in the study were eligible for inclusion. Participants stopped their background combination ART and received oral cabotegravir 30 mg once daily and oral rilpivirine 25 mg once daily orally for 4-6 weeks, followed by long-acting injectable cabotegravir 600 mg (3 mL) and long-acting injectable rilpivirine 900 mg (3 mL) intramuscularly at weeks 4 and 8, and every 8 weeks thereafter. The primary outcome was safety, including all adverse events, at week 24. Primary safety outcome measures were summarised as frequencies, percentages, and exact Clopper-Pearson 95% CIs in the evaluable analysis population, which included participants who were treated exclusively with the regimen and either completed all scheduled treatments or experienced severe adverse events, permanently discontinued the treatment, or died, whichever occurred first; and in the all-treated analysis population, which included all participants who received at least one dose of any study product. This study is registered with ClinicalTrials.gov (NCT3497676) and is ongoing. FINDINGS: Between July 26, 2021, and Aug 27, 2022, 44 (80·0%) of 55 adolescents who participated in cohort 1 and 100 (87·0%) of 115 screened study-naive adolescents were enrolled in cohort 2. 74 (51·4%) participants were female and 70 (48·6%) were male. Overall, 15 (10·8% [95% CI 6·2-17·2]) of all 139 participants in the evaluable analysis population had at least one adverse event of grade 3 or above by week 24. Among 142 participants who received at least one injection, 43 (30%) experienced at least one injection site reaction (ISR). All 106 ISRs were either grade 1 (98 [92·5%]) or grade 2 (eight [7·5%]), and 97 (91·5%) resolved within 7 days. No participant experienced a drug-related serious adverse event or prematurely discontinued treatment due to a drug-related adverse event. INTERPRETATION: Long-acting injectable cabotegravir and long-acting injectable rilpivirine, administered to adolescents at recommended adult dosages every 8 weeks, showed no unanticipated safety concerns in the 24 weeks following administration. FUNDING: National Institutes of Health, ViiV Healthcare, and Johnson & Johnson.