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- Title
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
Peluso, Michael J; Dee, Lynda; Shao, Shirley; Taylor, Jeff; Campbell, Danielle; Collins, Simon; Gandhi, Monica; Johnston, Rowena; Deeks, Steven G; Sauceda, John A; Dubé, Karine
- 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.
- Subjects
UNITED States; HIV infections; EXPERIMENTAL design; HUMAN research subjects; ANTIRETROVIRAL agents; INFORMED consent (Medical law); INTERPROFESSIONAL relations; STRUCTURED treatment interruption; RISK management in business; COVID-19 pandemic; ANALYTICAL chemistry; MEDICAL research
- Publication
Clinical Infectious Diseases, 2021, Vol 72, Issue 10, p1843
- ISSN
1058-4838
- Publication type
Article
- DOI
10.1093/cid/ciaa1260