Operationalizing HIV cure-related trials with analytic treatment interruptions during the SARS-CoV-2 pandemic: A collaborative approach.

Efforts to recognize and minimize the risk to study participants will be necessary to safely and ethically resume scientific research in the context of the ongoing SARS-CoV-2 pandemic. These efforts are uniquely challenging in the context of HIV-cure clinical trials, which often involve complex experimental therapy regimens and perhaps analytic treatment interruption (ATI), in which participants pause antiretroviral therapy (ART). In this viewpoint, we discuss our approach to re-opening an HIV-cure trial in this context, with a focus on key considerations regarding study design, informed consent and participant education, and study implementation. These recommendations might be informative to other groups seeking to resume HIV-cure research in settings similar to ours.