The RIO trial: rationale, design, and the role of community involvement in a randomised placebo-controlled trial of antiretroviral therapy plus dual long-acting HIV-specific broadly neutralising antibodies (bNAbs) in participants diagnosed with recent HIV infection—study protocol for a two-stage randomised phase II trial

Background: Antiretroviral therapy (ART) has led to dramatic improvements in survival for people living with HIV, but is unable to cure infection, or induce viral control off therapy. Designing intervention trials with novel agents with the potential to confer a period of HIV remission without ART r...

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Bibliographic Details
Main Authors:	Ashraf, A. (Author), Babalis, D. (Author), Box, H. (Author), Brown, H. (Author), Caskey, M. (Author), Cole, T. (Author), Collins, S. (Author), Deeks, S. (Author), Falaschetti, E. (Author), Fidler, S. (Author), Fox, J. (Author), Frater, J. (Author), Horowitz, J. (Author), Hurley, L. (Author), Jacob, M. (Author), Johnson, N. (Author), Khan, M. (Author), Lee, M.J (Author), Nussenzweig, M.C (Author), Ogbe, A. (Author), Pace, M. (Author), Prevost, A.T (Author), Sutherland, E. (Author), Zacharopoulou, P. (Author)
Format:	Article
Language:	English
Published:	BioMed Central Ltd 2022
Subjects:	adult antibody blood level antibody combining site antibody detection antibody specificity antiretroviral therapy Antiretroviral therapy antiretrovirus agent Article biological monitoring Broadly neutralising antibodies Broadly Neutralizing Antibodies CD4 antigen clinical trial protocol Clinical Trials, Phase II as Topic community participation Community Participation controlled study coronavirus disease 2019 COVID-19 drug efficacy drug infusion drug safety female HIV HIV Antibodies HIV Infections HIV-1 human human cell Human immunodeficiency virus Human immunodeficiency virus 1 Human immunodeficiency virus antibody Human immunodeficiency virus infected patient Human immunodeficiency virus infection Humans immunological parameters infection control infection risk long acting drug major clinical study male neutralizing antibody nonhuman open study phase 2 clinical trial phase 2 clinical trial (topic) placebo Primary infection Prospective Studies prospective study quality of life Quality of Life randomized controlled trial randomized controlled trial (topic) Randomized Controlled Trials as Topic retreatment risk reduction SARS-CoV-2 study design T cell Immunity treatment outcome Treatment Outcome viremia Virological remission virus DNA virus transmission
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