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Overview of CAPRISA
Overview of CAPRISA
Overview of CAPRISA
Overview of CAPRISA
Overview of CAPRISA
Overview of CAPRISA
Overview of CAPRISA
Overview of CAPRISA
Overview of CAPRISA
Overview of CAPRISA
Overview of CAPRISA
Overview of CAPRISA
Overview of CAPRISA
Overview of CAPRISA
Overview of CAPRISA
Overview of CAPRISA
Overview of CAPRISA
Overview of CAPRISA
Overview of CAPRISA
Overview of CAPRISA
Overview of CAPRISA
Overview of CAPRISA
Overview of CAPRISA
Overview of CAPRISA
Overview of CAPRISA
Overview of CAPRISA
Overview of CAPRISA
Overview of CAPRISA
Overview of CAPRISA
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Overview of CAPRISA

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  • 1. Overview of CAPRISA <ul><li>Presented at the : </li></ul><ul><li>CAPRISA Scientific Advisory </li></ul><ul><li>Board Meeting, Durban – 5 May 03 </li></ul><ul><li>Salim S. Abdool Karim </li></ul><ul><li>Deputy Vice-Chancellor (Research) - University of Natal </li></ul><ul><li>Director: CAPRISA (Centre for the AIDS Programme of Research in South Africa) </li></ul><ul><li>Professor of Clinical Epidemiology – Columbia University </li></ul><ul><li>Adjunct Professor of Medicine – Cornell University </li></ul>
  • 2. A multi-institutional collaboration, incorporated as an independent non-profit AIDS Research Organisation Registration Number: 2002/024027/08 http://www.caprisa.org
  • 3. Major partners: University of Natal, University of Cape Town, University of Western Cape, National Institute for Communicable Diseases and Columbia University Minor partners and researchers from: Aurum Health Research, Nell & Shapiro, MRC, Yale University, Harvard University, Duke University, University of North Carolina, and University of Washington - Seattle
  • 4. CAPRISA is funded by DAIDS, NIAID, NIH as part of the CIPRA program. Grant # 1U19AI51794 – approx R23million / year Also home to several other NIH funded projects
  • 5. <ul><li>BOARD </li></ul><ul><li>CM de la Rey (C) </li></ul><ul><li>BD Schoub </li></ul><ul><li>AG Rosenfield </li></ul><ul><li>JM van Bever Donker </li></ul><ul><li>EA Ngara </li></ul><ul><li>SS Abdool Karim </li></ul><ul><li>R Hoff </li></ul><ul><li>EXECUTIVE COMMITTEE </li></ul><ul><li>SS Abdool Karim (D) </li></ul><ul><li>C Williamson </li></ul><ul><li>CM Gray </li></ul><ul><li>E Susser </li></ul><ul><li>G Churchyard </li></ul><ul><li>J Frohlich </li></ul><ul><li>MJ Matjila </li></ul><ul><li>L Morris </li></ul><ul><li>JCM Swart </li></ul><ul><li>Q Abdool Karim </li></ul><ul><li>S Cassol </li></ul><ul><li>U Lalloo </li></ul><ul><li>W Hide </li></ul><ul><li>SCIENTIFIC </li></ul><ul><li>ADVISORY BOARD </li></ul><ul><li>HM Coovadia (C) </li></ul><ul><li>D Martin </li></ul><ul><li>AA Azad </li></ul><ul><li>LE Makubalo </li></ul><ul><li>NP Simelela </li></ul><ul><li>SR Benatar </li></ul><ul><li>V Mizrahi </li></ul><ul><li>ZL Mkhize </li></ul>
  • 6. <ul><li>To undertake globally relevant and locally responsive research that contributes to understanding HIV pathogenesis and epidemiology as well as the nexus between tuberculosis and AIDS care </li></ul><ul><li>To provide training through research fellowships tenable both in South Africa and the USA </li></ul><ul><li>To build local research infrastructure through cores of expertise, equipment and labs </li></ul>Goals
  • 7. CAPRISA Projects <ul><li>The Start Project </li></ul><ul><li>The viral set point in HIV-1 subtype C infection: Role of host and viral factors </li></ul><ul><li>Anal sex and HIV transmission in adolescent women in rural South Africa </li></ul><ul><li>Immune reconstitution and predictors of tuberculosis while on antiretroviral therapy </li></ul>
  • 8. CAPRISA Associated Projects <ul><li>Adult AIDS Clinical Trails Unit (ACTG 5175) </li></ul><ul><li>HIV Prevention Trials Network (HPTN 035) </li></ul><ul><li>Community Based Voluntary Counselling and Testing </li></ul><ul><li>Stigma project (JOHAP) </li></ul>
  • 9. CAPRISA Cores <ul><li>Administration Core: Research administration, finance, human resources and information technology </li></ul><ul><li>Laboratory Cores: Viral genetics, bioinformatics, HLA, cellular immunology, humoral immunology, molecular virology, microbiology – TB/STI </li></ul><ul><li>Epidemiology and Biostatistics Centre (also a Core) </li></ul><ul><li>Clinical Infectious Diseases Centre </li></ul><ul><li>Vulindledla – Gender and AIDS Centre </li></ul><ul><li>Training Programme </li></ul>
  • 10. CAPRISA Training <ul><li>Fogarty AIDS International Training and Research Program (AITRP) ($650k) </li></ul><ul><li>Fogarty International Clinical Operational, and Health Systems Research Training Award (ICOHRTA) ($600k) </li></ul><ul><li>CAPRISA training ($220k) </li></ul>
  • 11. Project START: S tarting T uberculosis and A nti- R etroviral T herapy <ul><li>Presented at the : </li></ul><ul><li>CAPRISA Scientific Advisory </li></ul><ul><li>Board Meeting, Durban – 5 May 03 </li></ul><ul><li>Salim S. Abdool Karim </li></ul><ul><li>Director: CAPRISA (Centre for the AIDS Programme of Research in South Africa) </li></ul><ul><li>Deputy Vice-Chancellor (Research) - University of Natal </li></ul><ul><li>Professor of Clinical Epidemiology – Columbia University </li></ul><ul><li>Adjunct Professor of Medicine – Cornell University </li></ul>
  • 12. START PROJECT Implementing Antiretroviral Therapy in Resource Constrained Settings: A Randomized Controlled Trial to Assess the effect of integrated Tuberculosis and HIV Care on the Incidence of AIDS-Defining Conditions and Survival in Participants Co-Infected with Tuberculosis and HIV S tarting T uberculosis and A nti- R etroviral T herapy
  • 13. START Protocol Team <ul><li>Pearl Pillay </li></ul><ul><li>Rod Hoff, MD </li></ul><ul><li>Kogieleum Naidoo, MBChB </li></ul><ul><li>Richard Hafner, MD </li></ul><ul><li>Farida Amod MBChB </li></ul><ul><li>Patricia Toro, MD </li></ul><ul><li>Andy Gray, MSc </li></ul><ul><li>Mark Lurie, PhD </li></ul><ul><li>Sharon Cassol, PhD </li></ul><ul><li>David Hoos, MD </li></ul><ul><li>Nesri Padayatchi, MBChB </li></ul><ul><li>Scott Hammer, MD </li></ul><ul><li>Gavin Churchyard, MBChB, PhD </li></ul><ul><li>Marita Murrman, PhD </li></ul><ul><li>Quarraisha Abdool Karim, PhD </li></ul><ul><li>Gerald Friedland, MD </li></ul><ul><li>Clive Gray, PhD </li></ul><ul><li>Wafaa El- Sadr, MD </li></ul><ul><li>Umesh Lalloo, MBChB, MD </li></ul>USA Investigators: South African Investigators:
  • 14. The evolving HIV Epidemic in South Africa <ul><li>SA accounts for about 10% of the global burden of HIV Infection </li></ul><ul><li>4.7million HIV+ : More HIV infected people in South Africa than any other country </li></ul><ul><li>TB is the most common presenting feature of AIDS </li></ul>
  • 15. Prevalence and incidence of HIV infection among prenatal clinic attenders aged 15-49 in Hlabisa: 1992-1999 Year N Prevalence of HIV (95% Cl) Incidence Rate 1992 1993 1995 1997 1998 1999 882 709 314 4731 3166 3041 4.2% (3.0-5.7) 7.9% (6.0-10.1) 14.0% (10.4-18.4) 27.2% (25.9-28.5) 29.9% (28.4-31.6) 34.0% (32.3-35.7) 2.3% 7.2% 8.2% 9.9% 19.8% Source: Williams B, Gouws E, Wilkinson D, Abdool Karim SS. Estimating HIV incidence rates from age prevalence data in epidemic situations.  Stats in Med 2001; 20: 2003-2016.
  • 16. 0 200 400 600 800 1000 1200 1400 1600 1800 2000 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 0 5 10 15 20 25 30 35 40 Number Source: Hlabisa Hospital Records Tuberculosis caseload and antenatal HIV prevalence
  • 17. AIDS AT KEH VIII, DURBAN - 1998 <ul><li>54% of Medical Ward in-patients were HIV+ </li></ul><ul><li>84% of HIV+ met WHO AIDS case criteria </li></ul><ul><li>56% HIV+ co-infected with tuberculosis </li></ul><ul><li>AIDS patients younger (34.9 vs 47.1 years) </li></ul><ul><li>Case fatality rates: HIV+ = 22% vs 9% in HIV- </li></ul><ul><li>Source: Colvin M, Dawood S, Kleinschmidt I, Mullick S, Lalloo U. Int J STD AIDS 2001, 386-389 </li></ul>
  • 18. Why integrate TB and AIDS? <ul><li>How to identify 4.7m HIV+ from 42m people? </li></ul><ul><li>How to identify the few hundred thousand who have low CD4 counts from the 4.7m people? </li></ul><ul><li>Unique opportunity because of HIV-TB co-infection </li></ul><ul><li>TB is rapidly rising </li></ul><ul><li>TB care infrastructure already exists </li></ul><ul><li>Source: Abdool Karim SS et al. CAPRISA application, 2001. </li></ul>
  • 19. Why use TB to identify patients for AIDS treatment? <ul><li>Need an ethical approach of identifying those most in need efficiently </li></ul><ul><li>Hospital AIDS patients are important target but are often too far advanced </li></ul><ul><li>PHC patients without TB have lower HIV infection rates and most will be too early for treatment – hence less cost-effective </li></ul><ul><li>AIDS patients with TB often present when CD4 counts are at a level indicating the need to start therapy </li></ul><ul><li>TB-HIV co-infected patients have high mortality rates </li></ul>
  • 20. TB and AIDS co-infection rates in 2001 <ul><li>KZN: 65,654 cases – 64.6% HIV+ </li></ul><ul><li>Mpumalanga: 15,657 cases – 59.1% HIV+ </li></ul><ul><li>Gauteng: 45,598 cases – 44.8% HIV+ </li></ul><ul><li>Western Cape: 34,211 cases – 31.6% HIV+ </li></ul><ul><li>South Africa: 273,365 cases – 47.6% HIV+ </li></ul><ul><li>Source: Fourie PB, 2001. </li></ul>
  • 21. Benefits of integrating TB and AIDS <ul><li>Besides efficiency and cost-effectiveness </li></ul><ul><li>Adherence to medication </li></ul><ul><li>Synergy in use of DOTS </li></ul><ul><li>Existing DOTS program </li></ul>
  • 22. Problems in integrating TB and AIDS <ul><li>Pill burden during first 2 months </li></ul><ul><li>Drug interactions, side effects and toxicities </li></ul><ul><li>Paradoxical reactions </li></ul><ul><li>TB = 5 days a week; AIDS = 7 days a week </li></ul><ul><li> plus will need post 6-month care </li></ul>
  • 23. Operational issues in integrating TB and AIDS care <ul><li>VCT in TB services </li></ul><ul><li>Disclosure to treatment supervisors </li></ul><ul><li>Must not compromise TB services </li></ul><ul><li>Advantage of operational efficiency – makes ART feasible in resource-constrained settings </li></ul>
  • 24. Pilot study at Cyril Zulu Communicable Disease Centre in Durban <ul><li>20 TB patients started on ART </li></ul><ul><li>2 patients discontinued treatment a few weeks after starting </li></ul><ul><li>Adherence - very high </li></ul><ul><li>Clinical and lab marker response – good </li></ul><ul><li>Source: Jack C, Friedland G, Lalloo UG, Abdool Karim Q, Cassol S, Abdool Karim SS. Pilot study of integrating TB and ART. Barcelona conference, 2002. </li></ul>
  • 25. Study goals and objectives PRIMARY OBJECTIVE: To assess the effectiveness of integrated tuberculosis and HIV care provision, including HAART administered through an enhanced TB-DOT program, versus sequential treatment of TB and HIV, by comparing the 18-month incidence of subsequent AIDS-defining illnesses and mortality among participants co-infected with TB and HIV.
  • 26. Study secondary objectives <ul><li>To assess: </li></ul><ul><li>Safety/tolerability of combining anti-TB drugs with ART </li></ul><ul><li>Adherence to anti-TB and ARV drugs </li></ul><ul><li>Biological markers, clinical status & quality of life in co- infected people </li></ul><ul><li>Incidence of immune reconstitution illness </li></ul><ul><li>TB and ARV drug resistance </li></ul><ul><li>Impact of ARV on HIV risk-related behaviours </li></ul><ul><li>Impact of integrating TB and HIV care on TB relapse rates </li></ul>
  • 27. Study design Enrolment 6 months 12months 18months ARV Self-Administration Control TB DOT Cyril Zulu CDC TB Randomized 1:1 AIDS Clinic King Edward Hospital ARV Self-Administration Integrated TB & ARV DOT with adherence intervention Intervention
  • 28. CIPLA once a day ARV therapy lamivudine (3TC) – 300mg didanosine (ddI) – 400mg efavirenz (EFV) – 600mg Odivir- 400 kit
  • 29. Conclusion <ul><li>Integrating TB and AIDS is viable </li></ul><ul><li>Efficient approach to identifying those most in need </li></ul><ul><li>Advantages and disadvantages </li></ul><ul><li>A clinical trial is needed to establish whether integrated or sequential care is more effective </li></ul>

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