Operationalizing Human Immunodeficiency Virus Cure-related Trials with Analytic Treatment Interruptions During the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Pandemic: A Collaborative Approach

Authors:
Publisher website
Google Scholar
Abstract
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 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. These efforts are uniquely challenging in the context of human immunodeficiency virus (HIV) cure clinical trials, which often involve complex experimental therapy regimens and perhaps analytic treatment interruption, in which participants pause antiretroviral therapy. In this viewpoint, we discuss our approach to reopening 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.
Funding Information
  • National Institute of Allergy and Infectious Diseases
  • National Institutes of Health (T32 AI60530–12)
  • Human Immunodeficiency Virus Cure Research (amfAR 109301)
  • Delaney AIDS Research Enterprise (UM1AI126611)
  • National Institute of Mental Health (R21MH118120)

This publication has 18 references indexed in Scilit: