In a recently published study, researchers and community advocates associated with the amfAR Institute for HIV Cure Research have outlined their approach to safely undertaking an HIV cure trial in the context of COVID-19. The study, led by Dr. Michael Peluso, will help guide the complex clinical trial recently launched at the amfAR Institute after COVID-related delays. amfAR’s Dr. Rowena Johnston was a co-author of the study.
Dr. Peluso and colleagues focused on key considerations including study design, informed consent, participant education, and study implementation. They noted several key risks for participants such as the possibility of acquiring COVID-19 due to the high frequency of study visits and the incompletely understood interaction between HIV and the coronavirus—especially for people living with HIV. Of particular concern to researchers is the risk associated with suspending antiretroviral treatment during the trial.
“In light of these considerations, we developed and implemented recommendations prior to re-opening a clinical trial that may be used as a model for similar HIV cure-related research operations that are attempting to open in the context of the ongoing SARS-CoV-2 [COVID-19] pandemic,” the authors stated. The study was published in the journal Clinical Infectious Diseases.
Read the full study here.
Read more about the amfAR Cure Institute clinical trial here.