Balancing Statistical Power and Risk in HIV Cure Clinical Trial Design

JSY Lau; D Cromer; M Pinkevych; SR Lewin; TA Rasmussen; JH McMahon; MP Davenport

Conference Proceedings

Balancing Statistical Power and Risk in HIV Cure Clinical Trial Design

JSY Lau, D Cromer, M Pinkevych, SR Lewin, TA Rasmussen, JH McMahon, MP Davenport

Journal of Infectious Diseases | Published : 2022

DOI: 10.1093/infdis/jiac032

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Abstract

Background. Analytical treatment interruptions (ATI) are pauses of antiretroviral therapy (ART) in the context of human immunodeficiency virus (HIV) cure trials. They are the gold standard in determining if interventions being tested can achieve sustained virological control in the absence of ART. However, withholding ART comes with risks and discomforts to trial participant. We used mathematical models to explore how ATI study design can be improved to maximize statistical power, while minimizing risks to participants. Methods. Using previously observed dynamics of time to viral rebound (TVR) post-ATI, we modelled estimates for optimal sample size, frequency, and ATI duration required to de..

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University of Melbourne Researchers

Jillian Lau Author

Sharon Lewin Author

Thomas Rasmussen Author

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Grants

Awarded by National Health and Medical Research Council

Funding Acknowledgements

This work was supported by the National Health and Medical Research Council (NHMRC) of Australia (grant number APP1149990 to M. P. D. and S. R. L.); and an National Health and Medical Research Council-European Union collaborative award (grant number APP1115828 to M. P. D.). M. P. D. and D. C. are recipients of NHMRC Investigator awards (grant number 1173528). J. S. Y. L. is a postgraduate fellow (grant number 1151607) and S. R. L. is a practitioner fellow (grant number 1135851) of the NHMRC.