Browsing by Author "Calabrese K"

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    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.
    (2024-Apr) 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; Centre for Infectious Disease Research in Zambia/University of Alabama Birmingham, Lusaka, Zambia.; The Children's Hospital of Philadelphia, Division of General Pediatrics and Global Health Center, Philadelphia, PA, USA.; Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.; The Children's Hospital of Philadelphia, Division of General Pediatrics and Global Health Center, Philadelphia, PA, USA; University of Pennsylvania Perelman School of Medicine, Departments of Pediatrics and Biostatistics, Epidemiology and Informatics, Philadelphia, PA, USA. Electronic address: lowenthale@chop.edu.; Frontier Science Foundation, Amherst, NY, USA.; Janssen Research and Development, Beerse, Belgium.; Keck School of Medicine of the University of Southern California, Los Angeles, CA, USA.; Emory University School of Medicine, Atlanta, GA, USA.; Northwestern University and Lurie Children's Hospital of Chicago, Chicago, IL, USA.; University of Pennsylvania School of Nursing, Philadelphia, PA, USA.; Johns Hopkins University School of Medicine, Baltimore, MD, USA.; St Jude Children's Research Hospital, Memphis, TN, USA.; National Institute of Allergy and Infectious Diseases (NIAID) Division of AIDS, National Institutes of Health (NIH), Rockville, MD, USA.; ViiV Healthcare, Madrid, Spain.; ViiV Healthcare, Research Triangle Park, NC, USA.; University of Colorado School of Medicine, Aurora, CO, USA.; FHI 360 IMPAACT Operations Center, Durham, NC, USA.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    BACKGROUND: Long-acting injectable cabotegravir and rilpivirine have demonstrated safety, acceptability, and efficacy in adults living with HIV-1. The IMPAACT 2017 study (MOCHA study) was the first to use these injectable formulations in adolescents (aged 12-17 years) living with HIV-1. Herein, we report acceptability and tolerability outcomes in cohort 1 of the study. METHODS: In this a secondary analysis of a phase 1/2, multicentre, open-label, non-comparative dose-finding study, with continuation of pre-study oral combination antiretroviral treatment (ART), 55 adolescents living with HIV-1 were enrolled to receive sequential doses of either long-acting cabotegravir or rilpivirine and 52 received at least two injections. Participants had a body weight greater than 35 kg and BMI less than 31·5 kg/m FINDINGS: Between March 19, 2019, and Nov 25, 2021, 55 participants were enrolled into cohort 1. Using the six-point face scale, 43 (83%) of participants at week 4 and 38 (73%) at week 8 reported that the injection caused "no hurt" or "hurts little bit", while only a single (2%) participant for each week rated the pain as one of the two highest pain levels. Quality of life was not diminished by the addition of one injectable antiretroviral. In-depth interviews revealed that parents and caregivers in the USA frequently had more hesitancy than adolescents about use of long-acting formulations, but parental acceptance was higher after their children received injections. INTERPRETATION: High acceptability and tolerability of long-acting cabotegravir or rilpivirine injections suggests that these are likely to be favoured treatment options for some adolescents living with HIV. FUNDING: National Institutes of Health and ViiV Healthcare.
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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; University of Pennsylvania Perelman School of Medicine, Children's Hospital of Philadelphia, Philadelphia, PA, USA.; Janssen Research and Development, Beerse, Belgium.; Frontier Science Foundation, Boston, MA, USA.; FHI 360, Durham, NC, USA.; University of Colorado School of Medicine, Aurora, CO, USA.; Emory University School of Medicine-Children's Healthcare of Atlanta, Atlanta, GA, USA.; ViiV Healthcare, ResearchTriangle Park, NC, USA.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia; University of Alabama, Birmingham, AL, USA.; ViiV Healthcare, Madrid, Spain.; Baragwanath Academic Hospital, Johannesburg, South Africa.; Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.; Frontier Science Foundation, Amherst, NY, USA.; Chiangrai Prachanukroh Hospital, Chiang Rai, Thailand.; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.; Johns Hopkins University School of Medicine, Baltimore, MD, USA.; University of California San Diego, La Jolla, CA, USA.; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Bethesda, MD, USA.; St Jude Children's Research Hospital, Memphis, TN, USA. Electronic address: aditya.gaur@stjude.org.; GlaxoSmithKline, Mississauga, ON, Canada.; 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.