At what CD4+T cell count should antiretroviral therapy (ART) for HIV be initiated?

Updated: Jul 27, 2020
  • Author: Shelley A Gilroy, MD, FACP, FIDSA; Chief Editor: Michael Stuart Bronze, MD  more...
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The first randomized controlled trial to investigate the question of when to initiate therapy was the NIH Comprehensive International Program of Research on AIDS (CIPRA) HT 001 clinical study. This work showed that starting antiretroviral therapy at CD4+ T-cell counts between 200 and 350 cells/µL improves survival compared with deferring treatment until the CD4+ T-cell count drops to less than 200 cells/µL (the standard of care at the time).

Interim analysis of CIPRA HT 001 showed that of 816 HIV-infected adults with early HIV disease, 6 of those who began antiretroviral therapy within 2 weeks of enrollment (early treatment) died, while 23 participants in the standard-of-care group died. [117] Among participants who began the study without tuberculosis infection, 18 individuals in the early treatment group developed tuberculosis, while 36 people in the standard-of-care group developed tuberculosis.

These interim results were statistically significant and led to ending the trial early to offer antiretroviral therapy to all participants in the standard-of-care group with a CD4+ T-cell count of less than 350 cells/µL.

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