Recommendations for analytical antiretroviral treatment interruptions in HIV research trials—report of a consensus meeting

Publication date: Available online 15 March 2019Source: The Lancet HIVAuthor(s): Boris Julg, Lynda Dee, Jintanat Ananworanich, Dan H Barouch, Katharine Bar, Marina Caskey, Donn J Colby, Liza Dawson, Krista L Dong, Karine Dubé, Joseph Eron, John Frater, Rajesh T Gandhi, Romas Geleziunas, Philip Goulder, George J Hanna, Richard Jefferys, Rowena Johnston, Daniel Kuritzkes, Jonathan Z LiSummaryAnalytical antiretroviral treatment interruption (ATI) is an important feature of HIV research, seeking to achieve sustained viral suppression in the absence of antiretroviral therapy (ART) when the goal is to measure effects of novel therapeutic interventions on time to viral load rebound or altered viral setpoint. Trials with ATIs also intend to determine host, virological, and immunological markers that are predictive of sustained viral control off ART. Although ATI is increasingly incorporated into proof-of-concept trials, no consensus has been reached on strategies to maximise its utility and minimise its risks. In addition, differences in ATI trial designs hinder the ability to compare efficacy and safety of interventions across trials. Therefore, we held a meeting of stakeholders from many interest groups, including scientists, clinicians, ethicists, social scientists, regulators, people living with HIV, and advocacy groups, to discuss the main challenges concerning ATI studies and to formulate recommendations with an emphasis on strategies for risk mitigation and monitoring, ART re...
Source: The Lancet HIV - Category: Infectious Diseases Source Type: research