Browsing by Author "Masheto G"

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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; Center for Biostatistics in AIDS Research, Harvard T H Chan School of Public Health, Boston, MA, USA.; University of Pennsylvania Perelman School of Medicine, Children's Hospital of Philadelphia, Philadelphia, PA, USA.; Janssen Research and Development, Beerse, Belgium.; St Jude Children's Research Hospital, Memphis, TN, USA.; SMG Pharma Safety GlaxoSmithKline, Middlesex, UK.; FHI 360, Durham, NC, USA.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia; University of Alabama at Birmingham, Birmingham, AL, USA. Electronic address: carolyn.bolton@cidrz.org.; ViiV Healthcare, Madrid, Spain.; Certara, Radnor, PA, USA; GlaxoSmithKline, Collegeville, PA, USA.; Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, 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.; Botswana Harvard Health Partnership, Gaborone, Botswana.; Baylor College of Medicine Children's Foundation Uganda, Kampala, Uganda.; Perinatal HIV Research Unit, University of Witwatersrand, Johannesburg, South Africa.; University of California San Diego, La Jolla, CA, USA.; Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, Thailand.; University of California Los Angeles, Los Angeles, CA, USA.; GlaxoSmithKline, Mississauga, ON, Canada.; Frontier Science Foundation, Brookline, MA, USA.; 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.
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    Slow Acceptance of Universal Antiretroviral Therapy (ART) Among Mothers Enrolled in IMPAACT PROMISE Studies Across the Globe.
    (2019-Sep) Stranix-Chibanda L; Brummel S; Pilotto J; Mutambanengwe M; Chanaiwa V; Mhembere T; Kamateeka M; Aizire J; Masheto G; Chamanga R; Maluwa M; Hanley S; Joao E; Theron G; Nevrekar N; Nyati M; Santos B; Aurpibul L; Mubiana-Mbewe M; Oliveira R; Anekthananon T; Mlay P; Angelidou K; Tierney C; Ziemba L; Coletti A; McCarthy K; Basar M; Chakhtoura N; Browning R; Currier J; Fowler MG; Flynn P; Instituto of Pediatrics Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.; Kilimanjaro Christian Medical Centre, Moshi, Tanzania.; Harvard T.H. Chan School of Public Health, Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.; Centre Aids Prevention Research South Africa (CAPRISA), University of KwaZulu-Natal, Durban, South Africa.; Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, USA.; University of Zimbabwe College of Health Sciences, Paediatrics and Child Health, Harare, Zimbabwe. lstranix@uzchs-ctrc.org.; College of Medicine - Johns Hopkins Research Project, Blantyre, Malawi.; University of North Carolina Project, Lilongwe, Malawi.; University of Zimbabwe College of Health Sciences - Clinical Trials Research Centre, 15 Phillips Avenue, Belgravia, Harare, Zimbabwe.; Department of Infectious Diseases, St Jude Children's Research Hospital, Memphis, TN, USA.; Perinatal HIV Research Unit, Johannesburg, South Africa.; Division of Infectious Diseases, University of California Los Angeles, Los Angeles, USA.; Harvard T.H. Chan School of Public Health, Center for Biostatistics in AIDS Research in the Department of Biostatistics, Boston, USA.; Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, USA.; Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.; Department of Obstetrics and Gynaecology, Stellenbosch University, Cape Town, South Africa.; FHI 360, IMPAACT Operations Center, Durham, NC, USA.; University of Zimbabwe College of Health Sciences - Clinical Trials Research Centre, 15 Phillips Avenue, Belgravia, Harare, Zimbabwe. lstranix@uzchs-ctrc.org.; Frontier Science and Technology Research Foundation, Amherst, USA.; Department of Infectious Diseases, Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil.; Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, USA.; Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, China.; Hospital Nossa Senhora da Conceicao, Porto Alegre, Brazil.; Laboratorio de AIDS e Imunologia Molecular - Fiocruz, Hospital Geral de Nova Iguacu, Rio de Janeiro, Brazil.; Makerere University - Johns Hopkins University Research Collaboration, Kampala, Uganda.; Department of Obstetrics and Gynaecology, BJ Government Medical College, Pune, India.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    The PROMISE trial enrolled asymptomatic HIV-infected pregnant and postpartum women not eligible for antiretroviral treatment (ART) per local guidelines and randomly assigned proven antiretroviral strategies to assess relative efficacy for perinatal prevention plus maternal/infant safety and maternal health. The START study subsequently demonstrated clear benefit in initiating ART regardless of CD4 count. Active PROMISE participants were informed of results and women not receiving ART were strongly recommended to immediately initiate treatment to optimize their own health. We recorded their decision and the primary reason given for accepting or rejecting the universal ART offer after receiving the START information. One-third of participants did not initiate ART after the initial session, wanting more time to consider. Six sessions were required to attain 95% uptake. The slow uptake of universal ART highlights the need to prepare individuals and sensitize communities regarding the personal and population benefits of the "Treat All" strategy.