Study 105 Atazanavir + [Cobicistat or Ritonavir] + TDF-FTC (Phase 2) - PowerPoint PPT Presentation

Jun 12, 2023 •250 likes •314 views

Atazanavir + [Cobicistat or Ritonavir] + TDF-FTC (Phase 2) Study 105 Atazanavir + [Cobicistat or Ritonavir] + TDF-FTC (Phase 2) Study 105: Study Design Study Design: 105 Background : Randomized, partially placebo- controlled, double-blind

Atazanavir + [Cobicistat or Ritonavir] + TDF-FTC (Phase 2) Study 105
Atazanavir + [Cobicistat or Ritonavir] + TDF-FTC (Phase 2) Study 105: Study Design Study Design: 105 • Background : Randomized, partially placebo- controlled, double-blind phase 2 trial to compare the safety and efficacy of cobicistat and ritonavir as pharmacokinetic enhancers administered with Atazanavir-cobicistat + atazanavir and fixed-dose tenofovir DF- Tenofovir DF-Emtricitabine emtricitabine in treatment-naïve adults with HIV (n = 50) infection 2x • Inclusion Criteria (n = 85) 1x - Age ≥18 - Antiretroviral treatment-naïve Atazanavir + Ritonavir + - HIV RNA ≥ 5000 copies/ml Tenofovir DF-Emtricitabine - CD4 count >50 cells/mm 3 (n = 29) • Treatment Arms (all once daily) - Atazanavir-cobicistat (300/150 mg) + TDF-FTC - Atazanavir 300 mg + Ritonavir 100 mg + TDF-FTC Source: Elion R, et al. AIDS. 2011;25:1881-6.
Atazanavir + [Cobicistat or Ritonavir] + TDF-FTC (Phase 2) Study 105: Results Week 24 and 48: Virologic Response (ITT, Missing=Failure) Atazanavir-cobicistat + TDF-FTC Atazanavir + Ritonavir + TDF-FTC 100 86 86 HIV RNA <50 copies/mL (%) 84 82 80 60 40 20 0 24 Weeks 48 Weeks Study Week Source: Elion R, et al. AIDS. 2011;25:1881-6.
Atazanavir + [Cobicistat or Ritonavir] + TDF-FTC (Phase 2) Study 105: Results Adverse Events and Treatment Discontinuations Atazanavir/cobicistat + FTC-TDF Atazanavir/ritonavir + FTC-TDF 100 100 96 80 Patients (%) 60 48 36 40 17 20 14 4 3 0 Treatment-related Treatment Ocular Hyperbilirubinemia AEs discontinuation icterus/jaundice due to AEs Source: Elion R, et al. AIDS. 2011;25:1881-6.
Atazanavir + [Cobicistat or Ritonavir] + TDF-FTC (Phase 2) Study 105: Conclusions Conclusion : “Using cobicistat and ritonavir as pharmacoenhancers for atazanavir and administered with emtricitabine/tenofovir DF achieved comparable rates of virologic suppression and CD4 cell count increase with satisfactory safety profiles.” Source: Elion R, et al. AIDS. 2011;25:1881-6.
Acknowledgment The National HIV Curriculum is an AIDS Education and Training Center (AETC) Program resource funded by the United States Health Resources and Services Administration. The project is led by the University of Washington and the AETC National Coordinating Resource Center. The content in this slide set does not represent the official views of the U.S. Department of Health and Human Services, Health Resources & Services Administration.

Recommend

Setting the Scene Study 1 PI/ Study 2 Study 3- II PIII CRO Integrated Study 2

ICON CD04 - Ensuring Compliant and Consistent Data Mappings for SDTM-based Studies an ICON Approach Jennie Mc Guirk 11 th October 2011 Setting the Scene Study 1 PI/ Study 2 Study 3- II PIII CRO Integrated Study 2 Custom

854 views • 17 slides

ITU ITU D Study Study Gr Groups oups Update on activities of ITU D Study Group 1 and 2

ITU ITU D Study Study Gr Groups oups Update on activities of ITU D Study Group 1 and 2 for the 2014 2017 study period ITU Asia Pacific Regional Development Forum 2016 About About ITU ITU D Study Study Gr Groups oups ITU ITU

659 views • 21 slides

STUDY 073 Simplification to Efavirenz-TDF-FTC Study 073: Design Study Design: Study 073

Simplification to Efavirenz-TDF-FTC STUDY 073 Simplification to Efavirenz-TDF-FTC Study 073: Design Study Design: Study 073 Background : Randomized, controlled, open label phase 3 trial evaluating a simplification strategy for patients

213 views • 6 slides

Presentation on Study Findings & Suggestions Study sponsored by: DeitY, GoI Study conducted

Assessment Study of Common Service Centre (CSC) Scheme in Seven States of India Presentation on Study Findings & Suggestions Study sponsored by: DeitY, GoI Study conducted by : CIPS-ASCI [Project Leader: Shri D. Chakrapani, IAS (Retd.)

865 views • 45 slides

Case study 2 Case study 2 Case study 2 Case study 2 Former Industrial Site, London: How has

Case study 2 Case study 2 Case study 2 Case study 2 Former Industrial Site, London: How has innovation helped to produce a cost effective remedial design? Challenging contaminant profile Taken a traditional / well understood remedial

912 views • 4 slides

Study GS-366-1216 Switch from TDF to TAF, each with RPV and FTC Study GS-366-1216: Design Study

Switching to TAF from TDF, each with RPV and FTC Study GS-366-1216 Switch from TDF to TAF, each with RPV and FTC Study GS-366-1216: Design Study Design: Study GS-366-1160 Background : Phase 3b, multinational, randomized, double-blind,

313 views • 8 slides

Study 109 Switch to Elvitegravir-Cobicistat-TAF-FTC Study 109: Design Study Design: Study 109

Switch from TDF-based to Elvitegravir-Cobicistat-TAF-FTC Study 109 Switch to Elvitegravir-Cobicistat-TAF-FTC Study 109: Design Study Design: Study 109 Background : Open-label, randomized study, Phase 3 trial comparing switch to

247 views • 8 slides

MULTIMODAL CORRIDOR STUDY Public Meeting November 17 th , 2016 Agenda Study Area &

BOSTON STREET MULTIMODAL CORRIDOR STUDY Public Meeting November 17 th , 2016 Agenda Study Area & Purpose Study Objective Study Team Data Collection Discussion Study Schedule Next Steps Study Corridor Project

424 views • 13 slides

Study 119 Simplification to EVG-COBI-TAF-FTC plus DRV Study 119: Design Study Design: Study 119

Simplification to EVG-COBI-TAF-FTC plus Darunavir Study 119 Simplification to EVG-COBI-TAF-FTC plus DRV Study 119: Design Study Design: Study 119 Background : Open-label, randomized Phase 3 trial comparing simplification to EVG-COBI-TAF-FTC

568 views • 8 slides

I-20 EAST TEXAS CORRIDOR STUDY Community Presentation About the Study About the Study

I-20 EAST TEXAS CORRIDOR STUDY Community Presentation About the Study About the Study 18-month study to be complete in December 2014 Focused on evaluating safety and capacity needs along I-20 through East Texas Work with

237 views • 10 slides

MOBILITY CHOICE STUDY MOBILITY CHOICE STUDY MOBILITY CHOICE STUDY Planning for Mobility in

MOBILITY CHOICE STUDY MOBILITY CHOICE STUDY MOBILITY CHOICE STUDY Planning for Mobility in Hillsborough County Tuesday, November 28 th , 2006 Lutz Community Center MOBILITY CHOICE STUDY MOBILITY CHOICE STUDY MOBILITY CHOICE STUDY Agenda I.

349 views • 18 slides

Wellington Public Transport Spine Study Study purpose Feasibility study Options for a

Wellington Public Transport Spine Study Study purpose Feasibility study Options for a high quality, high frequency PT system Key action from Ngauranga to Airport Corridor Plan (2008) Long-term outlook Study area

438 views • 26 slides

1 Dr. Alaa Olama, Project consultant 1 1- Objectives of the Study 2- The Technical Study 3-

1 Dr. Alaa Olama, Project consultant 1 1- Objectives of the Study 2- The Technical Study 3- The Financial Study 4- The Institutional regulatory Framework Study 6- Conclusion and Way Forward 2 1- Objectives of the Study 3 Technical Study

676 views • 28 slides

I TU-D Study Group Activities during the study period ( 2 0 1 4 -2 0 1 7 ) ASP Regional Developm

I TU-D Study Group Activities during the study period ( 2 0 1 4 -2 0 1 7 ) ASP Regional Developm ent Forum Manila, June 6 & 7 , 2 0 1 6 Yasuhiko Kaw asum i Vice Chair, I TU-D Study Group 1 ITU-D Study Groups Mandate There are

336 views • 19 slides

Status of the Study Interagency Study Team Modeling Group Meeting April 20, 2010 Study Purpose

Minnesota River Basin Integrated Watershed, Water Quality and Ecosystem Restoration Study Status of the Study Interagency Study Team Modeling Group Meeting April 20, 2010 Study Purpose To bring local, state and federal entities together

366 views • 17 slides

VI. The Feasibility Study VI. The Feasibility Study What is a feasibility study? What is a

Basi di Dati e Sistemi Informativi II VI. The Feasibility Study VI. The Feasibility Study What is a feasibility study? What is a feasibility study? What to study and conclude? What to study and conclude? Benefits and costs Benefits and costs

838 views • 34 slides

STUDY BRIEFING September 18, 2013 What is a Disparity Study? A disparity study refers to an

DISPARITY STUDY PHASE 1 STUDY BRIEFING September 18, 2013 What is a Disparity Study? A disparity study refers to an analysis of whether a disparity, or a difference, exists between the number of specified companies or groups that are

573 views • 33 slides

STUDY of RESPITE CARE STUDY of RESPITE CARE Report to the NC Study Commission on Aging March

STUDY of RESPITE CARE STUDY of RESPITE CARE Report to the NC Study Commission on Aging March 28, 2008 NC Department of Health and Human Services 1 House Bill 424 Directed DHHS to study Respite Care and recommend ways to improve the

604 views • 34 slides

WELCOME Study Island Overview What is Study Island? Study Islands online learning programs

WELCOME Study Island Overview What is Study Island? Study Islands online learning programs provide academic support through practice, immediate feedback, and built-in remediation to improve students performance in core skill areas.

292 views • 18 slides

Study 112 Elvitegravir-Cobicistat-TAF-FTC in Renal Impairment Study 112: Design Study Design:

Elvitegravir-Cobicistat-TAF-FTC in Renal Impairment Study 112 Elvitegravir-Cobicistat-TAF-FTC in Renal Impairment Study 112: Design Study Design: Study 112 24 Study Week: 0 48 Background : Open-label, single arm phase 3 trial evaluating

299 views • 10 slides

www.ncepod.org.uk #acuteNIV 1 Neil Smith Method 2 Study aim Study aim To identify and explore

www.ncepod.org.uk #acuteNIV 1 Neil Smith Method 2 Study aim Study aim To identify and explore avoidable and remediable factors in the process of care for patients treated acutely with non-invasive ventilation 3 Study aim Study objectives

1.48k views • 124 slides

Part 1 1: W Why s y study p y prophecy? y? A study of the end of days 1 2/14/16 What if I

2/14/16 A study of the end of days Part 1 1: W Why s y study p y prophecy? y? A study of the end of days 1 2/14/16 What if I were to give you the following predictions: 1. Saddam Hussein will destroy all but the island portion of New

281 views • 17 slides

Pencil Me In Difficulty finding study times? Too many assignments? Don't know your own study

Pencil Me In Difficulty finding study times? Too many assignments? Don't know your own study habits? Pencil Me In: a smart scheduler to find optimal study times for you Isaac Schaaf Jessica Tsang Vision Personal tracking for smart study

39 views • 3 slides

Turners Falls Instream Flow Study Study Process Overview Study Plan Scoping Meeting April 16,

Turners Falls Instream Flow Study Study Process Overview Study Plan Scoping Meeting April 16, 2013 Study Timing Relative to ILP schedule ILP Schedule Proposed Study Plans (PSP): 4/15/13 Study Plan Meeting: 5/14-15/13 Additional

494 views • 45 slides