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Tuberculosis-Associated Immune Reconstitution Inflammatory Syndrome: Case Definitions for Use in Resource-Limited Settings

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Tuberculosis-Associated Immune Reconstitution Inflammatory Syndrome: Case Definitions for Use in Resource-Limited Settings The copyright of this thesis vests in the author. No quotation from it or information derived from it is to be published without full acknowledgementTown of the source. The thesis is to be used for private study or non- commercial research purposes only. Cape Published by the University ofof Cape Town (UCT) in terms of the non-exclusive license granted to UCT by the author. University Diagnosis, treatment and immunopathogenesis of the HIV-associated tuberculosis immune reconstitution inflammatory syndrome Graeme Meintjes MBChB MRCP(UK) FCP(SA) DipHIVMan(SA) Thesis Presented for the Degree of DOCTOR OF PHILOSOPHY in the Department of Medicine UNIVERSITY OF CAPE TOWN August 2011 Supervisors: Professor Robert J. Wilkinson Professor Gary Maartens University of Cape Town University of Cape Town CONTENTS DECLARATION 1 ABSTRACT 7 ACKNOWLEDGEMENTS 9 CHAPTER 1 11 Introduction CHAPTER 2 23 Background and literature review CHAPTER 3 83 Tuberculosis-associated immune reconstitution inflammatory syndrome: case definitions for use in resource-limited settings CHAPTER 4 93 Novel relationship between tuberculosis immune reconstitution inflammatory syndrome and antitubercular drug resistance CHAPTER 5 105 Type 1 helper T cells and FoxP3-positive T cells in HIV-tuberculosis-associated immune reconstitution inflammatory syndrome CHAPTER 6 115 Randomized placebo-controlled trial of prednisone for paradoxical tuberculosis-associated immune reconstitution inflammatory syndrome CHAPTER 7 131 Corticosteroid modulated immune activation in HIV / tuberculosis-associated immune reconstitution inflammatory syndrome University of Cape Town CHAPTER 8 167 Conclusions University of Cape Town DECLARATION I, Graeme Ayton Meintjes, do hereby declare that this thesis includes five journal manuscripts. Four of these manuscripts (Chapter 3-6) have been published and the fifth (Chapter 7) has been submitted for publication in an international journal. The contents of each of these manuscripts remains unchanged from that which has been published or submitted for publication. The manuscripts are listed below, with a description of my contribution and the contribution of each author to the study. CHAPTER 3 Meintjes G, Lawn SD, Scano F, Maartens G, French MA, Worodria W, Elliott JH, Murdoch D, Wilkinson RJ, Seyler C, John L, van der Loeff MS, Reiss P, Lynen L, Janoff EN, Gilks C, Colebunders R; International Network for the Study of HIV- associated IRIS. Tuberculosis-associated immune reconstitution inflammatory syndrome: case definitions for use in resource-limited settings. Lancet Infect Dis. 2008;8(8):516-23. This manuscript arose from the founding meeting of the International Network for the Study of HIV-associated IRIS (INSHI) held in Kampala, Uganda, in 2006. Over 100 researchers attended. One of the aims of the meeting was to develop consensus case definitions for TB- IRIS to allow for standardization of research reports on TB-IRIS. Several groups presented the case definitions theyUniversity were using at the meeting. of Cape Our group wasTown conducting a clinical trial of TB-IRIS treatment at the time. We therefore had developed detailed clinical case definitions for TB-IRIS and had experience of using them in a prospective clinical study. These were presented at the meeting by Graeme Meintjes and formed the basic framework for the consensus case definitions that were developed at the meeting. Graeme Meintjes was given the role of heading the writing committee for the consensus case definitions and over the next year he co-ordinated via email the write-up of the manuscript that presents these case definitions. This involved drafting a manuscript, several rounds of comments from all co- authors and inclusion of these comments into revised versions by Graeme Meintjes who finalized the manuscript for submission. 1 He was assisted in particular by Stephen D. Lawn, Robert Colebunders, Gary Maartens and Robert J. Wilkinson. He was the first author on the final manuscript. CHAPTER 4 Meintjes G, Rangaka MX, Maartens G, Rebe K, Morroni C, Pepper DJ, Wilkinson KA, Wilkinson RJ. Novel relationship between tuberculosis immune reconstitution inflammatory syndrome and antitubercular drug resistance. Clin Infect Dis. 2009;48(5):667-76. Graeme Meintjes was the lead investigator on this clinical study. He designed the study. He was involved in patient assessment and collected clinical data. He was responsible together with Robert J. Wilkinson for data entry, management and analysis. He wrote the final manuscript which was reviewed by all authors critically. Dominique J. Pepper, Kevin Rebe and Molebogeng X. Rangaka worked on the study at the clinical site and were involved in patient assessment and collection of clinical data. Gary Maartens and Robert J. Wilkinson were involved in study design and supervised the study and writing of the manuscript. Robert J. Wilkinson also designed the study database. Chelsea Morroni andUniversity Molebogeng X. Rangaka of assisted Cape with statistical Town analysis. Katalin Wilkinson performed and supervised the performance of the ELISpot assays in the IIDMM laboratory and was involved in analysis of this data. CHAPTER 5 Meintjes G, Wilkinson KA, Rangaka MX, Skolimowska K, van Veen K, Abrahams M, Seldon R, Pepper DJ, Rebe K, Mouton P, van Cutsem G, Nicol MP, Maartens G, Wilkinson RJ. Type 1 helper T cells and FoxP3-positive T cells in HIV-tuberculosis- 2 associated immune reconstitution inflammatory syndrome. Am J Respir Crit Care Med. 2008;178(10):1083-9. Graeme Meintjes was responsible for recruitment, clinical assessment, clinical data collection, entry and analysis at the GF Jooste site. He was involved in study design and was also involved in supervision of the patient recruitment at the Ubuntu TB-HIV Clinic, Site B Khayelitsha. He assisted with performance of the ELISpot assays in the laboratory. He was involved in laboratory data analysis and write up of the manuscript. Robert J. Wilkinson conceived and designed the study. He was responsible for overall supervision of the two clinical sites and the laboratory work. He designed the study database and assisted with data entry and was involved in study data analysis. Katalin Wilkinson supervised the laboratory assays (ELISpot and flow cytometry) that were perfomed by Kerryn Matthews (née van Veen), Ronette Seldon, Keira Skolimowska and Graeme Meintjes. The following were also involved in patient assessment and recording of clinical data: Dominique J. Pepper, Kevin Rebe, Musaed Abrahams , Gilles van Cutsem, Priscilla Mouton and Molebogeng X. Rangaka. Gary Maartens and Marc Nicol were involved in study design and review of the manuscript. University of Cape Town CHAPTER 6 Meintjes G, Wilkinson RJ, Morroni C, Pepper DJ, Rebe K, Rangaka MX, Oni T, Maartens G. Randomized placebo-controlled trial of prednisone for paradoxical tuberculosis-associated immune reconstitution inflammatory syndrome. AIDS. 2010;24(15):2381-90. Graeme Meintjes was the lead investigator on this clinical trial. He was involved in study design and responsible for on-site co-ordination of the study. He was involved in patient 3 recruitment, assessment, follow-up and collected clinical data. He clinically assessed and provided consultant input on all 110 patients enrolled in the trial. He was responsible together with the study statistician (Chelsea Morroni) for data management and analysis. He wrote the final manuscript which was reviewed by all authors critically. Graeme Meintjes was also a co-author on the successful grant application to the Medical Research Council (MRC) of South Africa that funded the study and he played a key role in writing this grant. Robert J. Wilkinson was involved in study design and co-ordination. Gary Maartens was the study principal investigator and involved in study design and co-ordination. Both supervised the study and writing of the manuscript. Dominique J. Pepper, Kevin Rebe, Molebogeng X. Rangaka and Tolu Oni worked on the study at the clinical site and were involved in patient recruitment, follow-up and collection of clinical data. CHAPTER 7 Meintjes G, Skolimowska KH, Wilkinson KA , Conesa Botella A, Matthews K, Tadokera R, Rangaka MX, Rebe K, Pepper DJ, Morroni C, Colebunders R, Maartens G, Wilkinson RJ. Corticosteroid modulated immune activation in HIV / tuberculosis- associated immune reconstitution inflammatory syndrome. Submitted for publication. This immunology studyUniversity was conducted on samples of Cape collected from Town patients during the randomized controlled trial of prednisone for TB-IRIS. The role of Graeme Meintjes and others in the clinical aspects of this trial have been described above. The immunology study was designed and supervised by Robert J. Wilkinson. The laboratory work for this study was supervised by Katalin Wilkinson and Robert J. Wilkinson. The assays (ELISpot, PCR and Luminex multiplex) were performed by Keira Skolimowska, Katalin Wilkinson, Graeme Meintjes, Kerryn Matthews, Rebecca Tadokera and Anali Conesa Botella. 4 Graeme Meintjes was involved in study design and was responsible for laboratory data analysis, taking the raw laboratory data, synthesizing it with the clinical data, data cleaning and statistical analysis. He wrote the first draft of the manuscript, which was critically reviewed by all co-authors prior to submission. Keira Skolimowska and Anali Conesa Botella assisted with data analysis. I confirm that no part of this thesis has been submitted in the past, or is being, or is to be submitted for a degree at this or any other
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