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Hoffmann, R. A wiki for the life sciences where authorship matters. Nature Genetics (2008)
 
 
 

Progression to AIDS or death as endpoints in HIV clinical trials.

PURPOSE: To assess progression to AIDS or death from month 4 after a protease inhibitor-containing regimen is initiated in a cohort of 1,281 patients. METHOD: We used Kaplan-Meier estimates of probability of clinical progression. RESULT: At month 4, most patients had an HIV-1 RNA plasma value below 500 copies/mL (78%) and a CD4 cell count above 300 cells/mm(3) (62%). Starting from month 4, clinical progression at 1 and 2 years of follow-up was low (<3% at 1 year) in patients with HIV RNA <500 copies/mL or 500-10,000 copies/mL and in patients with CD4 between 50 and 300 cells/mm(3) or >300 cells/mm(3). A higher risk of clinical progression (> or =10% at 1 year) was evidenced only in patients with poor response to antiretroviral therapy, that is, with CD4 <50 cells/mm(3) or CD4 between 50-300 cells/mm(3) together with an HIV RNA >10,000 copies/mL. CONCLUSION: In patients currently on antiretroviral therapy, clinical trials with clinical progression as endpoint are almost not feasible, except in patients with a poor immunovirological response to first- or second-line HAART.[1]

References

  1. Progression to AIDS or death as endpoints in HIV clinical trials. Raffi, F., Chêne, G., Lassalle, R., May, T., Billaud, E., Fleury, H., Dellamonica, P., Leport, C. HIV clinical trials. (2001) [Pubmed]
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