NAME: Naidoo, Kogieleum
eRA COMMONS USERNAME (credential, e.g., agency login): naidookogie 

POSITION TITLE: Head of Treatment Research Programme

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) 
​INSTITUTION AND LOCATION


​DEGREE (if applicable)

​END DATE
MM/YYYY
​FIELD OF STUDY​


​University of Natal, Durban, KwaZulu-Natal
College of Medicine, Johannesburg,
Gauteng, University of KwaZulu-Natal, Durban,
KwaZulu-Natal
MBChB
Diploma
PHD

​12/1992
12/2002
12/2016

​Medicine
Diploma in HIV Management
Public Health Medicine

A. Personal Statement
I am currently Head of the Treatment Research Program at the Centre of the AIDS Programme of Research in South Africa (CAPRISA) and Honorary Associate Professor in the College of Health Sciences, University of KwaZulu-Natal, Durban, South Africa. My contribution to HIV and TB treatment spans two decades.

I have been a lead investigator in several Phase II and III TB-HIV and drug resistant-TB treatment trials. I have been a lead investigator in CAPRISA’s clinical studies aimed at optimizing treatment strategies for TB-HIV co-infected patients, most notably the CAPRISA SAPiT trial, which served as the basis for TB-HIV treatment integration guidance incorporated into the WHO international guidelines, the US government DHHS, the British HIV Association and the South African treatment guidelines for TB-HIV co-infected individuals. My research on immune reconstitution inflammatory syndrome and rifampicin-efavirenz drug interactions has been influential in defining treatment strategies for these two common complications of integrating TB-HIV treatment. I am currently principal investigator on the Newton Fund/South African Medical Research Council funded cluster-randomized study addressing the scale-up of TB-HIV integration in rural primary health care clinics in KwaZulu-Natal. I lead the CAPRISA study on TB recurrence in TB-HIV co-infected patients, the CAPRISA Improving Retreatment Success (IMPRESS) trial, a randomized controlled trial comparing two treatment regimens for patients with retreatment pulmonary TB.

I serve as co-Principal Investigator in the Individualized M(X) drug- resistant TB Treatment Strategy Study, a strategy to improve treatment outcomes in patients with drug-resistant TB and co-investigator of the Correlate of Risk Targeted Intervention study that evaluates a targeted screen and treat strategy for tuberculosis. I served as site investigator on several international multi-center multi-country collaborative clinical trials sponsored by the of the US National Institute of Health including the A5221, A5253, A5255, A5274 and A5304 studies. In addition, I serve on data safety monitoring committees for various community-based strategy studies aimed at enhancing TB treatment and prevention outcomes, and as Advisor, guiding policy and clinical governance in TB-HIV service integration in KwaZulu-Natal.

I serve on the WHO HIV Clinical Guidelines committee and the TB-HIV Technical Working Group. I also serve as a reviewer for several leading international journals and was awarded the SA Medical Research Council post intern research scholarship in 1994, the Fogarty Ellison Research Scholarship in Global Health in 2005, and the 2013 Union Scientific Prize awarded by the International Union against Tuberculosis and Lung Disease. The following publications highlight my experience and qualifications for this project:


B. Positions and Honors
Positions and Employment
​1995 - 2000 Clinical Investigator, Paediatric Transmission of AIDS (Petra) Trial, Durban
​1999 - 2000 Clinical investigator, South African Intrapartum Neviripine (SAINT) Study, Durban
​2001 - 2002 Co-director Khanyisa HIV Treatment Centre, St Aidan’s Mission Hospital
​2001 - 2003 Medical Officer King Edward VIII Hospital adult HIV clinic, King Edward VIII Hospital, Durban
​2004 - 2011 Project Director START study and CAPRISA AIDS Treatment Programme, CAPRISA, Durban
​2007 -  Head of Treatment Research Programme, CAPRISA, Durban
​2018 -  Honorary Associate Professor, University of KwaZulu-Natal, Durban
Other Experience and Professional Memberships
​1992 -  Registered as a Medical Practitioner, South African Health professions Council
​2005 -  Member, Medical Professions Society
​2007 -  Executive Member, CAPRISA-Scientific Committee
​2009 - 2011 Care and Support Technical Task Team, SANAC Joint TB/HIV and Treatment
​2012 -  Data monitoring committee member, the TB Fast Track Study funded by the MRC/Wellcome Trust/Department for International Development Global Health Trials
​2012 - 2014 Member, National Institutes of Health Adult Clinical Trials Group's Tuberculosis Transformative Science Group (TSG)
​2012 - 2014 Member, National Institutes of Health Adult Clinical Trials Group's Site Management and Clinical Care Committee
​2013 - 2014 Member, National Institutes of Health Adult Clinical Trials Group's Host Directed Therapy Working Group
​2015 -  Member, South African National TB Think Tank Committee
​2016 -  Executive member, CAPRISA - Board of Control
​2019 -  Member, WHO HIV-TB Implementation for Impact Working Group
Honors
​1985 Good fellowship award, Protea Secondary School
​1986 Dux Award, Protea Secondary School
​1992 Best Orthopaedic student Prize, UKZN-Nelson R Mandela School of Medicine
​1993 Post Intern Scholarship, South African Medical Research Council
​2005 Fogarty Ellison Clinical Research Scholarship, Fogarty International Center
​2013 Union Scientific Prize, International Union against Tuberculosis and Lung Disease
​C. Contribution to Science
​1. Understanding TB-HIV associated mortality:
​Our research into optimal timing of antiretroviral therapy (ART) in HIV-TB co-infected patients in the CAPRISA 003 trial has shown that survival was significantly improved in patients who received integrated treatment instead of sequential treatment (5.4 deaths per 100 person-years as compared with 12.1 per 100 person-years) (NEJM 2010, 362:697-706).
​These results have impacted national and global TB-HIV treatment policies. On World AIDS Day in 2009, the South African government announced a change in tuberculosis-HIV co-treatment guidelines, drawing on the SAPIT trial results. Also in December 2009, the World Health Organization issued a series of rapid advice documents on the provision of antiretroviral therapy among co-infected patients using the results from the CAPRISA 003 trial as evidence. The results could save thousands of lives as it provides an affordable and effective strategy for the successful implementation of ART in the developing world.
  • ​Padayatchi N, Abdool Karim SS, Naidoo K, Grobler A, Friedland G. Improved survival in multidrug-resistant tuberculosis patients receiving integrated tuberculosis and antiretroviral treatment in the SAPiT Trial. Int J Tuberc Lung Dis. 2014 Feb;18(2):147-54. PubMed PMID: 24429305; PubMed Central PMCID: PMC4770013.
  • Naidoo K, Baxter C, Abdool Karim SS. When to start antiretroviral therapy during tuberculosis treatment?. Curr Opin Infect Dis. 2013 Feb;26(1):35-42. PubMed PMID: 23188213; PubMed Central PMCID: PMC3616247.
  • Abdool Karim SS, Naidoo K, Grobler A, Padayatchi N, Baxter C, Gray AL, Gengiah T, Gengiah S, Naidoo A, Jithoo N, Nair G, El-Sadr WM, Friedland G, Abdool Karim Q. Integration of antiretroviral therapy with tuberculosis treatment. N Engl J Med. 2011 Oct 20;365(16):1492-501. PubMed PMID: 22010915; PubMed Central PMCID: PMC3233684.
  • Abdool Karim SS, Naidoo K, Grobler A, Padayatchi N, Baxter C, Gray A, Gengiah T, Nair G, Bamber S, Singh A, Khan M, Pienaar J, El-Sadr W, Friedland G, Abdool Karim Q. Timing of initiation of antiretroviral drugs during tuberculosis therapy. N Engl J Med. 2010 Feb 25;362(8):697-706. PubMed PMID: 20181971; PubMed Central PMCID: PMC3076221.
​2. Addressing challenging clinical management issues associated with TB HIV integration:
​Impact of TB-HIV integration on Immune Reconstitution Inflammatory Syndrome (IRIS), Drug Interactions and Drug Toxicity: Paradoxical clinical deterioration from IRIS, drug Interactions and overlapping toxicity resulting from co-administration of ART and TB therapies remain major obstacles to antiretroviral therapy (ART) initiation during tuberculosis treatment. We have made substantial contributions through several publications in high impact journals in these areas.
  • ​Naidoo K, Abdool Karim Q, Bhushan A, Naidoo K, Yende-Zuma N, McHunu PK, Frohlich J, Karim F, Upfold M, Kocheleff P, Abdool Karim SS. High rates of tuberculosis in patients accessing HAART in rural South Africa. J Acquir Immune Defic Syndr. 2014 Apr 1;65(4):438-46. PubMed PMID: 24256629; PubMed Central PMCID: PMC3943690.
  • Naidoo A, Naidoo K, Yende-Zuma N, Gengiah TN, Padayatchi N, Gray AL, Bamber S, Nair G, Karim SS. Changes to antiretroviral drug regimens during integrated TB-HIV treatment: results of the SAPiT trial. Antivir Ther. 2014;19(2):161-9. PubMed PMID: 24176943; PubMed Central PMCID: PMC3984627. s
  • Naidoo K, Yende-Zuma N, Padayatchi N, Naidoo K, Jithoo N, Nair G, Bamber S, Gengiah S, El-Sadr WM, Friedland G, Abdool Karim S. The immune reconstitution inflammatory syndrome after antiretroviral therapy initiation in patients with tuberculosis: findings from the SAPiT trial. Ann Intern Med. 2012 Sep 4;157(5):313-24. PubMed PMID: 22944873; PubMed Central PMCID: PMC3534856.
  • Gengiah TN, Holford NH, Botha JH, Gray AL, Naidoo K, Abdool Karim SS. The influence of tuberculosis treatment on efavirenz clearance in patients co-infected with HIV and tuberculosis. Eur J Clin Pharmacol. 2012 May;68(5):689-95. PubMed PMID: 22108776; PubMed Central PMCID: PMC3888951.
3. Drug Resistant TB Research:
​Drug-resistant TB is emerging as a major public health crisis in our setting. My recent work aims to improving understanding of clinical and programmatic management of drug-resistant tuberculosis.

 

  • Wolf A, Padayatchi N, Naidoo K, Master I, Mathema B, O'Donnell MR. Spatiotemporal Clustering of Multidrug-Resistant and Extensively Drug-Resistant Tuberculosis Is Associated With Human Immunodeficiency Virus Status and Drug-Susceptibility Patterns in KwaZulu-Natal, South Africa. Clin Infect Dis. 2020 May 6;70(10):2224-2227. PubMed PMID: 31538648.
  • Perumal R, Abdelghani N, Naidu N, Yende-Zuma N, Dawood H, Naidoo K, Singh N, Padayatchi N. Risk of Nephrotoxicity in Patients With Drug-Resistant Tuberculosis Treated With Kanamycin/Capreomycin With or Without Concomitant Use of Tenofovir-Containing Antiretroviral Therapy. J Acquir Immune Defic Syndr. 2018 Aug 15;78(5):536-542. PubMed PMID: 29683992.
  • Dookie N, Rambaran S, Padayatchi N, Mahomed S, Naidoo K. Evolution of drug resistance in Mycobacterium tuberculosis: a review on the molecular determinants of resistance and implications for personalized care. J Antimicrob Chemother. 2018 May 1;73(5):1138-1151. PubMed PMID: 29360989; PubMed Central PMCID: PMC5909630.
  • Padayatchi N, Mahomed S, O’Donnell M, Conradie F, Naidoo K. The World Health Organization excludes Mycobacterium tuberculosis from the 2017 priority pathogens list. South African Medical Journal. 2017 May 10; 107(6):466.
​Complete List of Published Work in My Bibliography, please click here
D. Additional Information: Research Support and/or Scholastic Performance
Ongoing Research Support
​Gates MRI-TBV01-201, Naidoo, Kogieleum (PI)   09/30/2019-01/03/2025
Bill and Melinda Gates Medical Research Institute (Gates MRI)
REVAX: Randomized, placebo controlled, observer-blind, phase IIb study to evaluate the efficacy, safety, and immunogenicity of BCG revaccination in healthy adolescents for the prevention of sustained mycobacterium tuberculosis infection
Role: Principal Investigator
​1R01AI138646; Gandhi, Neel Rajnikant (PI)      01/17/2018-12/31/2022
National Institute of Allergy and Infectious Diseases
The Role of Casual Contact and Migration in XDR TB Transmission in South Africa: A Geospatial, Genomic and Social Network study.

The CONTEXT (Casual Contact and Migration in XDR TB) study will integrate geospatial, genomic, and social network data to comprehensively characterize the contributions of casual contact and migration to XDR TB transmission and generate concrete, actionable data to inform targeted public health interventions to curb the XDR TB epidemic.
Role: Co- Principal Investigator
​​MR/S004963/1; David Meya (PI)     10/01/2019 – 05/01/2022
HARVEST study
United Kingdom Medical Research Council (MRC) –Infectious Diseases Institute Limited (IDI)
High Dose Oral Rifampicin to Improve Survival from Adult Tuberculous Meningitis: A Double-blinded
Randomised Controlled Phase III Trial
Role: Co- Principal Investigator
1U2GGH001142; Naidoo, Kogieleum (PI)    04/01/2014 - 09/29/2020
Centers for Disease Control and Prevention
The CAPRISA Regional Center for Advanced Clinical Management
The major goal of this award is to establish 3 regional centers with high level capabilities for Advance Clinical Management of HIV/AIDS, and TB including drug resistant RB, for patients within KwaZulu-Natal.
Role: Principal Investigator
Completed Research Support
​​Extramural Unit; Abdool Karim, Salim S. (PI)   04/01/2015 - 03/31/2020
South African Medical Research Council
MRC-CAPRISA HIV-TB Pathogenesis and Treatment Research Unit
The major goal on this MRC extramural unit is to undertake research to reduce morbidity and mortality from HIV-TB co-infection.
Role: Co- Principal Investigator
​​OPP1137034; Hatherill, M (PI)     10/05/2015 - 12/31/2019
UCT/Bill & Melinda Gates Foundation
A Clinical Trial of a Correlate of Risk Targeted Screen and Treat Strategy to Impact TB Control
The major goal of this study is to control the global TB epidemic by testing a strategy to identify people with undiagnosed TB and people at high risk of developing TB disease using Correlates of risk, in order to treat them before they transmit TB to others.
Role: Co- Principal Investigator
​Newton Fund; Naidoo, Kogieleum (PI)     03/07/2016 - 09/30/2019
South African Medical Research Council
Addressing challenges in scaling up TB and HIV treatment integration in public health settings in South Africa
The major goal on this study is to develop, implement and evaluate an integrated TB-HIV primary care model of service delivery that can improve HIV and TB outcomes in co-infected patients.
Role: Principal Investigator
​U2G GH001142; Naidoo, Kogieleum (PI)   04/01/2014 - 09/29/2019
Center for Global Health (CGH)
GH13-1335, S. AFRICA: REGIONAL CENTER FOR ADVANCED CLINICAL MANAGEMENT
Role: Principal Investigator
MRC-SHIP Program; Scriba, Thomas (PI)    08/13/2014 - 07/31/2017
South African Medical Research Council
Systems immunology of ID93 vaccine-induced protection against recurrent TB disease
The aim of this consortium is to understand biomarkers of TB recurrence in multiple cohorts.
Role: Co- Principal Investigator
​BR-C 13/0056; Naidoo, Kogieleum (PI)     10/01/2014 - 09/30/2016
BroadReach/USAID
Addressing challenges in scaling up TB and HIV treatment integration in public health settings in South Africa
The major goal on this study is to develop, implement and evaluate an integrated TB-HIV primary care model of service delivery that can improve HIV and TB outcomes in co-infected patients.
Role: Principal Investigator
​5U2 GPS001350; Abdool Karim, Salim S. (PI)    10/01/2008 - 09/29/2014
Centers for Disease Control and Prevention /PEPFAR
CAPRISA AIDS Treatment Programme

The CAT programme aims to provide a comprehensive HIV/AIDS care package to people living with HIV/AIDS. The strength of the current CAPRISA AIDS Treatment (CAT) programme lies in its ability to provide an integrated package of prevention and treatment services and employs an innovative method of providing antiretroviral treatment (ART) by integrating the TB and HIV care as well as counseling and testing, family planning, sexually transmitted infections (STI) treatment, prophylaxis and treatment for opportunistic infections (OIs), and other HIV associated conditions at both an urban and rural site.
Role: Co-Investigator
​U01 AI069469; Abdool Karim, Salim S. (PI)    01/012/2007 - 12/31/2013
National Institutes of Health/NIAID
UKZN-CAPRISA HIV/AIDS Clinical Trials Unit
The major goal of this award is to conduct clinical trials of the new network leadership groups
Role: Co-Investigator
​HHMI 55007065; Naidoo, Kogieleum (PI)    09/01/2008 - 08/31/2012
Howard Hughes Medical Institute
TRuTH
The overall objective of the TRuTH (TB Recurrence upon Treatment with HAART) study is to determine the extent of and the reasons for reactivation and reinfection in incident culture positive cases of TB and HIV infected patients on HAART.
Role: Principal Investigator