PPT-Switch to DTG/3TC TANGO Design

Author : lam | Published Date : 2023-09-20

Endpoints Primary proportion of patients with HIV RNA 50 cmL at W48 ITTE snapshot noninferiority if upper margin of the twosided 95 CI for the difference 4 973

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Switch to DTG/3TC TANGO Design: Transcript

Endpoints Primary proportion of patients with HIV RNA 50 cmL at W48 ITTE snapshot noninferiority if upper margin of the twosided 95 CI for the difference 4 973 power Secondary proportion of patients with HIV RNA lt 50 cmL at W48 ITTE snapshot noninferiority if lower margin of the twosided 95 CI for the difference 8. Mahesh Balakrishnan. , Dahlia Malkhi, Ted Wobber, Ming Wu, Vijayan Prabhakaran Michael Wei, John D. Davis, Sriram Rao, Tao Zou, . Aviad. . Zuck. Microsoft Research. big . meta. data. design pattern: distribute data, . Mahesh Balakrishnan. , Dahlia Malkhi, Ted Wobber, Ming Wu, Vijayan Prabhakaran Michael Wei, John D. Davis, Sriram Rao, Tao Zou, . Aviad. . Zuck. Microsoft Research. big . meta. data. design pattern: distribute data, . EVENT:. O. rganised. in . Romania. by . Ascendis. (Sorin Paun) in June 2014. Tango miniworkshop . f. acilitated. by Tore . Bystrom. and Kjell Lindqvist. Purpose. : . give. . them. a . taste. . ATV/r 300/100 mg QD 3TC 300 mg QD. N = 133. N = 133. Continuación ATV/r 300/100 mg QD 2 NRTI . Diseño. Randomización. 1:1. Etiqueta abierta. Objetivo. Endpoint. primario: proporción de pacientes sin fallo al tratamiento a S48 . STARTMRK. GS-US-236-0102 . SINGLE. Walmsley. S. NEJM 2013;369:1807-18. Design. Objective. Non inferiority of DTG at W48: % HIV RNA < 50 c/mL by intention to treat, snapshot analysis (1-sided significance level of 2.5%, lower margin of . Amar. . Banerjee. . Puneet. . Patwari. Subhrojyoti. Roy . Chaudhuri. . Swaminathan. . Natarajan. Agenda. Context & History. Objectives: Drivers for the MDE Approach. Approach Overview. Control Systems DSL. Study. LPV/. r. bid + 3TC or FTC . qd. + NRTI. N =. 127. N =. 123. LPV/. r. bid + 3TC/FTC . qd. Design. Randomisation*. 1: 1. Open-label. Objective. Primary Endpoint :. proportion without treatment failure at W48 . WHO HQ. The role of DTG based regimens in first- and second-line HIV treatment and PEP – Updated WHO recommendations. HIV testing and care continuum (2017). Source: UNAIDS/WHO . estimates. 2016 WHO recommandations for 1st Line ART in . –. NAIVE ADULTS WITH HIV-1 INFECTION: 96-WEEK RESULTS FROM THE GEMINI STUDIES. 1. Fundación Huesped, Buenos Aires, Argentina; . 2. Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico; . GEMINI 1 and GEMINI 2: Week 48 Data. DTG + 3TC . versus . DTG + TDF-FTC as Initial ART. GEMINI 1 and 2: Background. Source: Cahn P, et al. Lancet. 2019;393:143-55.. Study Design: GEMINI 1 and 2. Background. ARV . strategies. DOR > DRV/r 1st line. (DRIVE-FORWARD W96). DTG. monotherapy. Switch PI/r-DTG (NEAT22). Switch RPV+DTG . (SWORD). Test and . Treat. D/C/F/TAF . (DIAMOND). −10% noninferiority margin for individual studies.. by Baseline NRTI Resistance . and Second-Line NRTI Use. Dannae. Brown,. 1. . Ruolan. Wang,. 2. Mark Underwood,. 2. Judy Hopking,. 3. Maria Claudia Nascimento,. 4. . Michael Aboud,. 4. . Jörg. Andrew Hill, Francois Venter, Eric . Delaporte. , . Simiso. Sokhela, Charles . Kouanfack. , . Michelle Moorhouse. , Kaitlyn McCann, Bryony Simmons. , . Alexandra . Calmy. Disclosures. Speaker fees and honoraria from Gilead Sciences, AbbVie, Cipla, Johnson and Johnson, Sanofi, Pfizer, ViiV Healthcare, Mylan and Southern African HIV Clinicians Society. ROCKET-1 Trial. Switch from EFV + ABC-3TC to EFV-TDF-FTC. ROCKET-1: Design. Source: Moyle GJ, et al. . PLoS. One. 2015;10:e0116297.. Immediate switch arm. EFV-TDF-FTC. . (n = 79). Delayed switch arm .

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