Recommendations from the 2nd Consensus Workshop on Analytical Treatment Interruption in HIV Research Trials.
Ndung'u T., Dong KL., Colby DJ., Deeks SG., Cotton MF., Dubé K., Goulder PJ., Julg B., Nsubuga M., Ajibola G., Bar KJ., Bengu N., Bwakura-Dangarembizi M., Caskey M., Cromhout G., Kekitiinwa AR., Kilembe W., Kuhn L., Likhitwonnawut U., Mgodi NM., Persaud D., Peluso MJ., Rasmussen TA., Romo M., Sacdalan C., Samaneka W., Shapiro R., Søgaard OS., Tudor-Williams G., Wambui C., Tressler R., Lewin SR., Crowell TA., Kasprowicz VO., Trautmann L., 2nd ATI Consensus Workshop .
Analytical treatment interruption (ATI) is an important tool to evaluate interventions designed to achieve HIV eradication or long-term control without antiretroviral therapy. We convened a stakeholder workshop to update the published recommendations for the conduct of ATI studies. Important changes to the recommendations include more lenient entry criteria on CD4 count, CD4 nadir, and past medical history, and allowance for greater variation based on regional standards. As the mechanism of potential HIV remission might rely on immune control, the criteria for antiretroviral therapy resumption now allow for longer periods of viraemia at higher levels to stimulate a more robust immune response. Greater emphasis is placed on the importance of psychosocial monitoring and support, the prevention of HIV transmission to partners during ATI, and the integration of sociobehavioural research into ATI studies. Recommendations for the conduct of paediatric and adolescent ATI trials, absent from previous guidelines, are now included. These recommendations, based on current available data, expert opinion, and community consultation, aim to help steer the safe and ethical implementation of the next generation of ATI trials as we continue the search for an HIV cure.