Assessment of HIV-1 patient recruitability in the Republic of Guinea-Bissau using African versus North American hematology and biochemistry reference intervals

Clin Vaccine Immunol. 2012 Aug;19(8):1322-5. doi: 10.1128/CVI.00170-12. Epub 2012 Jun 6.

Abstract

Hematology and biochemistry reference intervals have been derived from healthy, HIV-negative populations to guide clinical trials worldwide. However, it is less clear how such values may be applied to clinical trials involving HIV-infected individuals. We show that contradictory interpretations about patient recruitability are reached when applying African versus North American reference intervals to an HIV-1 cohort in Guinea-Bissau. These observations underscore the need to question non-African guidelines in the context of HIV intervention clinical trials in Africa.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Biomedical Research / methods*
  • Clinical Trials as Topic*
  • Female
  • Guidelines as Topic
  • Guinea-Bissau
  • HIV Infections / pathology*
  • HIV Infections / physiopathology*
  • Humans
  • Male
  • Middle Aged
  • North America
  • Patient Selection*
  • Reference Values*