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Raltegravir-intensified initial antiretroviral therapy in advanced HIV disease in Africa: A randomised controlled trial

Author

Listed:
  • Cissy Kityo
  • Alexander J Szubert
  • Abraham Siika
  • Robert Heyderman
  • Mutsa Bwakura-Dangarembizi
  • Abbas Lugemwa
  • Shalton Mwaringa
  • Anna Griffiths
  • Immaculate Nkanya
  • Sheila Kabahenda
  • Simon Wachira
  • Godfrey Musoro
  • Chatu Rajapakse
  • Timothy Etyang
  • James Abach
  • Moira J Spyer
  • Priscilla Wavamunno
  • Linda Nyondo-Mipando
  • Ennie Chidziva
  • Kusum Nathoo
  • Nigel Klein
  • James Hakim
  • Diana M Gibb
  • A Sarah Walker
  • Sarah L Pett
  • on behalf of the REALITY trial team

Abstract

Background: In sub-Saharan Africa, individuals infected with HIV who are severely immunocompromised have high mortality (about 10%) shortly after starting antiretroviral therapy (ART). This group also has the greatest risk of morbidity and mortality associated with immune reconstitution inflammatory syndrome (IRIS), a paradoxical response to successful ART. Integrase inhibitors lead to significantly more rapid declines in HIV viral load (VL) than all other ART classes. We hypothesised that intensifying standard triple-drug ART with the integrase inhibitor, raltegravir, would reduce HIV VL faster and hence reduce early mortality, although this strategy could also risk more IRIS events. Methods and findings: In a 2×2×2 factorial open-label parallel-group trial, treatment-naive adults, adolescents, and children >5 years old infected with HIV, with cluster of differentiation 4 (CD4) 0.7) and despite significantly greater VL suppression with raltegravir-intensified ART at 4 weeks (343/836 [41.0%] versus 113/841 [13.4%] with standard ART, p

Suggested Citation

  • Cissy Kityo & Alexander J Szubert & Abraham Siika & Robert Heyderman & Mutsa Bwakura-Dangarembizi & Abbas Lugemwa & Shalton Mwaringa & Anna Griffiths & Immaculate Nkanya & Sheila Kabahenda & Simon Wac, 2018. "Raltegravir-intensified initial antiretroviral therapy in advanced HIV disease in Africa: A randomised controlled trial," PLOS Medicine, Public Library of Science, vol. 15(12), pages 1-20, December.
    • Handle: RePEc:plo:pmed00:1002706
    DOI: 10.1371/journal.pmed.1002706
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