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CAPRISA 003: Timing of Antiretroviral Initiation in HIV-TB Co-infected Patients—The SAPiT Trial

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The CAPRISA Clinical Trials: HIV Treatment and Prevention

Abstract

This chapter describes the rationale for CAPRISA’s focus on HIV-TB co-infected patients; how the SAPiT trial evolved from prior studies undertaken by the team; the study design and important lessons from the conduct of this study. The importance of TB as a common opportunistic infection associated with advancing HIV disease providing an opportunity to efficiently identify patients with AIDS who would most benefit from access to antiretroviral treatment initiation in a context where knowledge of HIV status was low and access to ARV treatment was limited is underscored. The challenges in undertaking this study are described as well as the key factors that enabled us to successfully generate the scientific evidence for integration of TB and HIV services. It describes how chance encounters and strategic collaborations resulted in scientific results that changed local and international guidelines for managing TB-HIV co-infected patients. In addition to providing a synopsis of the key findings of the SAPiT study and key references for further reading, this chapter concludes with a sequential study of implementation of integration of HIV and TB treatment services in public sector health facilities highlighting the iterative nature of the knowledge generation process.

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References

  1. UNAIDS. AIDS Epidemic Update. Geneva, Switzerland: Joint United Nations Program on HIV/AIDS; 2001.

    Google Scholar 

  2. National Department of Health. HIV & AIDS and STI Strategic Plan for South Africa 2007-2011. South Africa: National Department of Health; 2007.

    Google Scholar 

  3. World Health Organization. Scaling up antiretrovral therapy in resource-scarce settings: treatment guidelines for a public health approach. Geneva, Switzerland: World Health Organization; 2003.

    Google Scholar 

  4. Colvin M, Dawood S, Kleinschmidt I, Mullick S, Lallo U. Prevalence of HIV and HIV-related diseases in the adult medical wards of a tertiary hospital in Durban, South Africa. International Journal of STD & AIDS. 2001; 12(6): 386–9.

    Google Scholar 

  5. Mukadi YD, Maher D, Harries A. Tuberculosis case fatality rates in high HIV prevalence populations in sub-Saharan Africa. AIDS. 2001; 15(2): 143–52.

    Google Scholar 

  6. Whalen C, Horsburgh CR, Hom D, Lahart C, Simberkoff M, Ellner J. Accelerated course of human immunodeficiency virus infection after tuberculosis. American Journal of Respiratory and Critical Care Medicine. 1995; 151(1): 129–35.

    Google Scholar 

  7. Elliott AM, Halwiindi B, Mwinga AG. Treatment of tuberculosis in HIV-infected patients in Zaire. The New England Journal of Medicine. 1995; 333(8): 519–20.

    Google Scholar 

  8. Schluger NW. Issues in the treatment of active tuberculosis in human immunodeficiency virus-infected patients. Clinical Infectious Diseases. 1999; 28(1): 130–5.

    Google Scholar 

  9. Whalen C, Okwera A, Johnson J, Vjecha M, Hom D, Wallis R, et al. Predictors of survival in human immunodeficiency virus-infected patients with pulmonary tuberculosis. The Makerere University-Case Western Reserve University Research Collaboration. American Journal of Respiratory and Critical Care Medicine. 1996; 153(6 Pt 1): 1977–81.

    Google Scholar 

  10. World Health Organization. TB/HIV research priorities in resource-limited settings: Report of an expert consultation. Geneva, Switzerland: World Health Organization; 2005 2005.

    Google Scholar 

  11. Kharsany A, Connolly C, Olowolagba A, Abdool Karim S, Abdool Karim Q. Increasing burden of pulmonary tuberculosis in young women. S Afr Med J. 2006; 96(6): 524–5.

    Google Scholar 

  12. Wilkinson D. High-compliance tuberculosis treatment programme in a rural community. Lancet. 1994; 343(8898): 647–8.

    Google Scholar 

  13. Jack C, Lalloo U, Abdool Karim Q, Abdool Karim S, El-Sadr W, Cassol S, et al. A pilot study of once-daily antiretroviral therapy integrated with tuberculosis directly observed therapy in a resource-limited setting. Journal of Acquired Immune Deficiency Syndromes. 2004; 36(4): 929–34.

    Google Scholar 

  14. Gengiah TN, Gray AL, Naidoo K, Abdool Karim Q. Initiating antiretrovirals during tuberculosis treatment: a drug safety review. Expert opinion on drug safety. 2011; 10(4): 559–74.

    Google Scholar 

  15. 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. European Journal of Clinical Pharmacology. 2012; 68(5): 689–95.

    Google Scholar 

  16. Gengiah TN, Botha JH, Yende-Zuma N, Naidoo K, Abdool Karim SS. Efavirenz dosing: influence of drug metabolizing enzyme polymorphisms and concurrent tuberculosis treatment. Antiviral Therapy. 2015; 20(3): 297–306.

    Google Scholar 

  17. Gengiah TN, Botha JH, Soowamber D, Naidoo K, Abdool Karim SS. Low rifampicin concentrations in tuberculosis patients with HIV infection. Journal of Infection in Developing Countries. 2014; 8(8): 987–93.

    Google Scholar 

  18. Abdool Karim SS, Naidoo K, Grobler A, Padayatchi N, Baxter C, Gray A, et al. Timing of initiation of antiretroviral drugs during tuberculosis therapy. New England Journal of Medicine. 2010; 362(8): 697–706.

    Google Scholar 

  19. Abdool Karim SS, Naidoo K, Grobler A, Padayatchi N, Baxter C, Gray AL, et al. Integration of antiretroviral therapy with tuberculosis treatment. New England Journal of Medicine. 2011; 365(16): 1492–501.

    Google Scholar 

  20. Naidoo K, Yende-Zuma N, Padayatchi N, Naidoo K, Jithoo N, Nair G, et al. The immune reconstitution inflammatory syndrome after antiretroviral therapy initiation in patients with tuberculosis: findings from the SAPiT trial. Annals of Internal Medicine. 2012; 157(5): 313–24.

    Google Scholar 

  21. Naidoo A, Naidoo K, Yende-Zuma N, Gengiah TN, Padayatchi N, Gray AL, et al. Changes to antiretroviral drug regimens during integrated TB-HIV treatment: results of the SAPiT trial. Antiviral Therapy. 2014; 19(2): 161–9.

    Google Scholar 

  22. Naidoo K, Grobler AC, Deghaye N, Reddy T, Gengiah S, Gray A, et al. Cost-Effectiveness of Initiating Antiretroviral Therapy at Different Points in TB Treatment in HIV-TB Coinfected Ambulatory Patients in South Africa. Journal of Acquired Immune Deficiency Syndromes. 2015; 69(5): 576–84.

    Google Scholar 

  23. 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. The International Journal of Tuberculosis and Lung Disease. 2014; 18(2): 147–54.

    Google Scholar 

  24. Boulle A, Clayden P, Cohen K, Cohen T, Conradie F, Dong K, et al. Prolonged deferral of antiretroviral therapy in the SAPIT trial: did we need a clinical trial to tell us that this would increase mortality? South African Medical Journal. 2010; 100(9): 566, 8, 70–1.

    Google Scholar 

  25. Abdool Karim Q, Abdool Karim SS, Baxter C, Friedland G, Gengiah T, Gray A, et al. The SAPIT trial provides essential evidence on risks and benefits of integrated and sequential treatment of HIV and tuberculosis. South African Medical Journal. 2010; 100(12): 808–9.

    Google Scholar 

  26. World Health Organization. Rapid advice: antiretroviral therapy for HIV infection in adults and adolescents. Geneva, Switzerland: World Health Organization; 2009.

    Google Scholar 

  27. Abdool Karim SS, Abdool Karim Q, Friedland G, Lalloo U, El-Sadr WM. Implementing antiretroviral therapy in resource-constrained settings: opportunities and challenges in integrating HIV and tuberculosis care. AIDS. 2004; 18(7): 975–9.

    Google Scholar 

  28. Török ME, Yen NTB, Chau TTH, Mai NTH, Phu NH, Mai PP, et al. Timing of initiation of antiretroviral therapy in human immunodeficiency virus (HIV)–associated tuberculous meningitis. Clinical Infectious Diseases. 2011; 52(11): 1374–83.

    Google Scholar 

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Correspondence to Nesri Padayatchi .

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Padayatchi, N., Naidoo, K., Gray, A., Abdool Karim, S.S., Grobler, A. (2017). CAPRISA 003: Timing of Antiretroviral Initiation in HIV-TB Co-infected Patients—The SAPiT Trial. In: Abdool Karim, Q., Abdool Karim, S., Baxter, C. (eds) The CAPRISA Clinical Trials: HIV Treatment and Prevention. Springer, Cham. https://doi.org/10.1007/978-3-319-47518-9_8

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  • DOI: https://doi.org/10.1007/978-3-319-47518-9_8

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  • Publisher Name: Springer, Cham

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