Recommendations for analytical antiretroviral treatment interruptions in HIV research trials-report of a consensus meeting
Por:
Julg, B, Dee, L, Ananworanich, J, Barouch, DH, Bar, K, Caskey, M, Colby, DJ, Dawson, L, Dong, KL, Dube, K, Eron, J, Frater, J, Gandhi, RT, Geleziunas, R, Goulder, P, Hanna, GJ, Jefferys, R, Johnston, R, Kuritzkes, D, Li, JZ, Likhitwonnawut, U, van Lunzen, J, Martinez-Picado, J, Miller, V, Montaner, LJ, Nixon, DF, Palm, D, Pantaleo, G, Peay, H, Persaud, D, Salzwedel, J, Salzwedel, K, Schacker, T, Sheikh, V, Sogaard, OS, Spudich, S, Stephenson, K, Sugarman, J, Taylor, J, Tebas, P, Tiemessen, CT, Tressler, R, Weiss, CD, Zheng, L, Robb, ML, Michael, NL, Mellors, JW, Deeks, SG and Walker, BD
Publicada:
1 abr 2019
Resumen:
Analytical 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 resumption criteria, and ethical considerations. In this Review, we present the major points of discussion and consensus views achieved with the goal of informing the conduct of ATIs to maximise the knowledge gained and minimise the risk to participants in clinical HIV research.
Filiaciones:
Julg, B:
Ragon Inst MGH MIT & Harvard, Cambridge, MA 02139 USA
Massachusetts Gen Hosp, Infect Dis Div, Boston, MA 02114 USA
Dee, L:
AIDS Act Baltimore, Baltimore, MD USA
Ananworanich, J:
Henry Jackson Fdn, US Mil HIV Res Program, Bethesda, MD USA
Barouch, DH:
Ragon Inst MGH MIT & Harvard, Cambridge, MA 02139 USA
Beth Israel Deaconess Med Ctr, Boston, MA 02215 USA
Bar, K:
Univ Penn, Dept Med, Philadelphia, PA 19104 USA
Caskey, M:
Rockefeller Univ, Lab Mol Immunol, 1230 York Ave, New York, NY 10021 USA
Colby, DJ:
Thai Red Cross AIDS Res Ctr, Bangkok, Thailand
Dawson, L:
NIAID, Fishers, Rockville, MD USA
Dong, KL:
Ragon Inst MGH MIT & Harvard, Cambridge, MA 02139 USA
Univ KwaZulu Natal, Durban, South Africa
Dube, K:
Univ N Carolina, Gillings Sch Global Publ Hlth, Chapel Hill, NC 27515 USA
Eron, J:
Univ N Carolina, Div Infect Dis, Chapel Hill, NC 27515 USA
Frater, J:
Univ Oxford, Nuffield Dept Med, Oxford, England
Hlth Res Biomed Res Ctr, Oxford Natl Inst, Oxford, England
Gandhi, RT:
Massachusetts Gen Hosp, Infect Dis Div, Boston, MA 02114 USA
Geleziunas, R:
Gilead Sci, Foster City, CA USA
Goulder, P:
Univ Oxford, Dept Paediat, Oxford, England
Hanna, GJ:
Merck, Kenilworth, NJ USA
Jefferys, R:
Treatment Act Grp, New York, NY USA
Johnston, R:
amfAR, New York, NY USA
Kuritzkes, D:
Brigham & Womens Hosp, Div Infect Dis, Cambridge, MA USA
Li, JZ:
Brigham & Womens Hosp, Div Infect Dis, Cambridge, MA USA
Likhitwonnawut, U:
AVAC Global Advocacy HIV Prevent, New York, NY USA
van Lunzen, J:
ViiV Healthcare, Brentford, England
:
AIDS Res Inst IrsiCaixa, Barcelona, Spain
Catalan Inst Res & Adv Studies, Barcelona, Spain
Cent Univ Catalonia, Univ Vic, Barcelona, Spain
Miller, V:
Forum Collaborat Res, Washington, DC USA
Montaner, LJ:
Wistar Inst Anat & Biol, Montaner Lab, 3601 Spruce St, Philadelphia, PA 19104 USA
Nixon, DF:
Weill Cornell Med Coll, Div Infect Dis, Dept Med, New York, NY USA
Palm, D:
Univ N Carolina, Global HIV Prevent & Treatment, Clin Trials Unit, Chapel Hill, NC 27515 USA
Pantaleo, G:
Ctr Hosp Univ, Serv Immunol & Allergy, Lausanne, Switzerland
Ctr Hosp Univ, Swiss Vaccine Res Inst, Lausanne, Switzerland
Peay, H:
Res Triangle Inst, POB 12194, Res Triangle Pk, NC 27709 USA
Persaud, D:
Univ N Carolina, Pediat Infect Dis, Sch Med, Chapel Hill, NC 27515 USA
Salzwedel, J:
AVAC Global Advocacy HIV Prevent, New York, NY USA
Salzwedel, K:
NIAID, Fishers, Rockville, MD USA
Schacker, T:
Univ Minnesota, Div Infect Dis & Int Med, Minneapolis, MN USA
Sheikh, V:
US FDA, Div Antiviral Prod, Ctr Drug Evaluat & Res, Silver Spring, MD USA
Sogaard, OS:
Aarhus Univ, Dept Infect Dis, Aarhus, Denmark
Spudich, S:
Yale Univ, Dept Neurol, New Haven, CT USA
Stephenson, K:
Ragon Inst MGH MIT & Harvard, Cambridge, MA 02139 USA
Beth Israel Deaconess Med Ctr, Boston, MA 02215 USA
Sugarman, J:
Univ N Carolina, Berman Inst Bioeth, Chapel Hill, NC 27515 USA
Taylor, J:
Univ N Carolina, Collaborator AIDS Researchers Eradicat, Chapel Hill, NC 27515 USA
Tebas, P:
Univ Penn, Perelman Sch Med, Philadelphia, PA 19104 USA
Tiemessen, CT:
Natl Inst Communicable Dis, Ctr HIV & STIs, Cell Biol Res Lab, Johannesburg, South Africa
Univ Witwatersrand, Fac Hlth Sci, Johannesburg, South Africa
Tressler, R:
NIAID, Fishers, Rockville, MD USA
Weiss, CD:
US FDA, Div Antiviral Prod, Ctr Drug Evaluat & Res, Silver Spring, MD USA
Zheng, L:
Harvard TH Chan Sch Publ Hlth, Dept Biostat, Boston, MA USA
Robb, ML:
Henry Jackson Fdn, US Mil HIV Res Program, Bethesda, MD USA
Michael, NL:
Henry Jackson Fdn, US Mil HIV Res Program, Bethesda, MD USA
Mellors, JW:
Univ Pittsburgh, Dept Med, Div Infect Dis, Pittsburgh, PA USA
Deeks, SG:
Univ Calif San Francisco, Sch Med, San Francisco, CA USA
Walker, BD:
Ragon Inst MGH MIT & Harvard, Cambridge, MA 02139 USA
Howard Hughes Med Inst, Chevy Chase, MD USA
Green Accepted, Green Published
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