Recommendations from the 2nd Consensus Workshop on Analytical Treatment Interruption in HIV Research Trials.
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.
Authors
Ndung'u Ndung'u, Dong Dong, Colby Colby, Deeks Deeks, Cotton Cotton, Dubé Dubé, Goulder Goulder, Julg Julg, Nsubuga Nsubuga, Ajibola Ajibola, Bar Bar, Bengu Bengu, Bwakura-Dangarembizi Bwakura-Dangarembizi, Caskey Caskey, Cromhout Cromhout, Kekitiinwa Kekitiinwa, Kilembe Kilembe, Kuhn Kuhn, Likhitwonnawut Likhitwonnawut, Mgodi Mgodi, Persaud Persaud, Peluso Peluso, Rasmussen Rasmussen, Romo Romo, Sacdalan Sacdalan, Samaneka Samaneka, Shapiro Shapiro, Søgaard Søgaard, Tudor-Williams Tudor-Williams, Wambui Wambui, Tressler Tressler, Lewin Lewin, Crowell Crowell, Kasprowicz Kasprowicz, Trautmann Trautmann,
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