Assessment of HIV-1 patient recruitability in the Republic of Guinea-Bissau using African versus North American hematology and biochemistry reference intervals.
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.
Department of Virology, Statens Serum Institut, Copenhagen, Denmark.
Victor Raúl
VR
Gómez Román
Sanne Skov
SS
Jensen
Christian
C
Leo-Hansen
Kristoffer Jarlov
KJ
Jensen
Christoph Mikkel
CM
Janitzek
Candida Medina
CM
Rodrigues
Sanne
S
Jespersen
Terese Lea
TL
Katzenstein
David da Silva
Dda S
Té
Anders
A
Fomsgaard
D000328:Adult; D035843:Biomedical Research / Q000379:methods*; D002986:Clinical Trials as Topic; D005260:Female; D017408:Guidelines as Topic; D006169:Guinea-Bissau; D015658:HIV Infections / Q000473:pathology* / Q000503:physiopathology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009656:North America; D018579:Patient Selection; D012016:Reference Values