Balancing Statistical Power and Risk in HIV Cure Clinical Trial Design.

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 detect a significant difference in the TVR between control and intervention groups. Group

SUBMITTER: Lau JSY 

PROVIDER: S-EPMC9400422 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature