Caro-Vega, Yanink
Schultze, Anna
W. Efsen, Anne Marie
Post, Frank A.
Panteleev, Alexander
Skrahin, Aliaksandr
Miro, Jose M.
Girardi, Enrico
Podlekareva, Daria N.
Lundgren, Jens D.
Sierra-Madero, Juan
Toibaro, Javier
Andrade-Villanueva, Jaime
Tetradov, Simona
Fehr, Jan
Caylà, Joan
Losso, Marcelo H.
Miller, Robert F.
Mocroft, Amanda
Kirk, Ole
Crabtree-Ramírez, Brenda
Funding for this research was provided by:
European Union’s Seventh Framework Programme for research (FP7/2007–2013)
Article History
Received: 28 June 2017
Accepted: 3 April 2018
First Online: 23 April 2018
Ethics approval and consent to participate
: The HIV/TB project was an observational study and patients were not exposed to any experimental interventions nor did the study intervene with the clinical management of the patient. The study only collected information from patient records and if necessary, patient interview. The study was conducted according to the current ethical standards including the WMA Declaration of Helsinki and was submitted to the appropriate regulatory authorities including ethical committees in the participating countries, as requested by local regulations. When informed consent was required by the local and/or national Ethics Committees, this was obtained prior to the initiation of any study related data being obtained. The consent form was approved by the IEC/IRB of each participating centre.In specific, IEC/IRB were obtained from the following commitees:Le Comité d’Ethique du C.H.U Saint-Pierre, Le Numéra registre AK/12–03-28/4128, Comité.Ético Cientifico del servicio de Salud Metropolitano Centra, Chil, certificado 452/11, De.Videnskabsetiske Komiteer i Region Hovedstaden Journal nr.: H-3-2011-095, United Kingdom national ethics approval Reference nr. 11/LO/0713 & R&D Reference nr. CSP 75430 for UK sites: Mortimor Market Centre, London, Imperial College Healthcare, London, St. Marys Hospital, London, North Manchester General Hospital, Manchester, Sheffield Teaching Hospitals, Sheffield, King’s College Hospital, London, North Middlesex University Hospital, London, Queen Elisabeth Hospital, London R&D ref. nr. SLHT/2011/UCSM/HIV/88, Leicester Royal Infirmary, Leicester. El Comité de Etica en Investigación en Salud, Hospital Paroissien Argentina 20/12/2911, Comité de Etica Iniciativa y Reflextion Bioetica Hospital Pineiro & Hospital Ramos Mejia Argentina 12/12/12, Comité de Bioética Reg. nr. 11,743/11 Hospital Nacional Profesor Alejandro Posdas Argentina, Comité Institucional de Ètica de la Investigacion en Salud del Nino u del Adulto Cordoba 16/12/2012 Hospital Rawson, Comité de Etica La Plata 12/11/12 Hospital Sa Juan de Dios Argentina, Comité de Ética en Investigacion Buenos Aires 18/11/12 Hospital Santojani Argentina & 11/05/2012 Hospital Fracisco Javier Muniz Argentina, Docencia e Investigación 15/06/12 Jujuy Argentina, Institutional Review Board Tbilisi Ref. nr. 12–007, Registro delle Sperimentazioni del Comitato Etico Rone nr. 24/2011 Spallanzani, Comitato Etico San Gerardo, Monza 26/05/2011, Comitato Etico Aziendale A.O.U. San Martino Genoa nr. 295 08/04/2011, Comitato Etico Indipendente Locale Policlinio Consorziale Bari nr. 624 28/09/2011, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Ref. nr 437, Comité de Ética del Hospital General Regional de León 10/10/2011, Secretario del Comité de Ensenanza, Investigacion y Ética Hospital Civil de Guadalajara Invest. Nr. 038/12, Comitato Etico Spedali Civili Brescia 07/06/2011 nr.36; Direcció General de Regularcio Barcelona CY-ANT-2011-01, Hospital Universitario Ramón y Cajal Comité Ético de Investigación Clinica 12/07/2011, Comite Etico de Investigation Clinica de Euscadi Vitoria 02/02/2012, Comité Ético de Investigación Clínica Hospital General Universitario Gregorio Maranon Madrid SAS/3470/2009, Kantonale Ethik-Kommission Zürich EK-793, Ethical Committee of Rep. Res. And Practical Centre for Pulmonology Minsk 11/02/2011, Ethical Committee of Gomel State Medical University & Gomel Regional Centre for Hygiene, Ethical Committee for Botkin Hospital & City TB Hospital ref. nr.23, Ethical Committee for Novgorod Centre for AIDS Prevention and Control 11/10/2011, Ethican Committee of Samara State Medical University 10/10/2012, Komisja Bioetycznego Uniwersytetu Medycznego w Bialymstoku Poland R-I-00/85c/2012 –R-I-002/85/2011, Tallinn Medical Research Ethics Committee Appr. Nr. 2555, RSU Etikas Komitejas Lemums Riga Nr. E-9(2), Vilniaus Regioninis Biomedicininiu Tyrimu Etikos Komitetas Nr. 158,200–07–363-90, Dr. Victor Babes Hospital Institutional Ethics Committee nr. 3889, Ethics Committee Crimean Republican AIDS Centre Nr. 462–13–08-12.The data storage and handling was protected in accordance with and approved by the Danish Data Protection Agency (Datatilsynet) under the Act on Processing of Personal Data (Act No. 429 of 31 May 2000) and European Commission Directive 95/46/EC.ExternalRef removed
: YCV, AS1, AMWE, AP, AS2, DNP, JDL, ST, ML, JT, JF, JC, JAV have no competing interests to declare.FAP, received honoraria and/or research funding from Abbvie, Gilead, ViiV, BMS, MSD and Janssen.JMM received a personal intensification research grant (number INT15/00168) during 2016 from the Instituto de Salud Carlos III, Ministerio de Economía y Competitividad, Madrid, Spain, and a personal 80:20 research grant from the Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain, during 2017–19.RFM has received honoraria from Gilead, Janssen, Merck, and ViiV for giving non-promotional lectures on clinical aspects of HIV; is a member of the British HIV Association Tuberculosis/HIV Guidelines Committee; and is a panel member for the Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents (National Institutes of Health, Centers for Disease Control and Prevention, HIV Medicine Association of the Infectious Diseases Society of America).JSM has received lecture fees, sponsorship, honoraria from Gilead, Stendhal, Abbvie, ViiV, Janssen and MSD.EG, Consultancy for Otsuka Novel Products, Speaker’s fee from Janssen, Gilead sciences, Angelini, Research Grant from Gilead sciences, Travel Grant from Janssen.AM, has have received lecture fees, sponsorship, honoraria or consultancy fees from ViiV, Pfizer, BMS, BI, Merck and Wragge LLC.OK had prior board membership at ViiV Healthcare, Gilead Sciences and Merck, received payment for lectures and/or for development of educational presentations from Abbott, Gilead Sciences, Tibotec and Quagen, and had travel/accommodations/meeting expenses paid by Abbott, BMS, Gilead Sciences, Merck and ViiV Healthcare – all outside the submitted work.BCR, has received lecture fees, sponsorship, honoraria from Gilead, Stendhal, Abbvie, Janssen and MSD.
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