title: Incidence of pancreatitis in HIV-1-infected individuals enrolled in 20 adult AIDS clinical trials group studies: lessons learned.
abstract: OBJECTIVE
  To report on the incidence of clinical- and laboratory-defined pancreatitis in HIV-1-infected individuals treated with antiretrovirals (ARVs).
  
  
  METHODS
  Pancreatitis incidence rates were calculated based on a Poisson distribution for subjects enrolled in 1 or more of 20 Adult AIDS Clinical Trials Group studies from October 1989 through July 1999.
  
  
  RESULTS
  A total of 8451 subjects were enrolled. The overall pancreatitis rates were 0.61 per 100 person-years (PYs) clinical and 2.23 per 100 PYs clinical/laboratory. Pancreatitis rates for single, dual, and triple nucleoside reverse transcriptase inhibitors (NRTIs) were similar. Rates of pancreatitis in didanosine (ddI) arms seemed to be dose dependent. Pancreatitis rates in ddI/hydroxyurea (HU) arms were not significantly different from the rates for ddI alone. Overall pancreatitis rates for ddI/stavudine (d4T) trials were high at 4.16 per 100 PYs clinical and 6.25 per 100 PYs clinical/laboratory. The highest rates were seen with the combination of indinavir (IDV)/ddI/d4T with or without HU.
  
  
  CONCLUSIONS
  The combination of NRTIs and definition has an impact on the incidence of pancreatitis. Standardization of definition and more comprehensive evaluations are needed to determine how much of this pancreatitis is directly caused by ARVs and how much is attributable to preexisting comorbidities and other known risk factors.
authors.affiliation: Institute of Human Virology, University of Maryland School of Medicine, Baltimore, MD 21201, USA. reisler@umbi.umd.edu
authors.forename: Ronald B
authors.initials: RB
authors.lastname: Reisler
authors.forename: Robert L
authors.initials: RL
authors.lastname: Murphy
authors.forename: Robert R
authors.initials: RR
authors.lastname: Redfield
authors.forename: Robert A
authors.initials: RA
authors.lastname: Parker
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000150:complications* / Q000188:drug therapy; D016049:Didanosine / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D015497:HIV-1; D006801:Humans; D006918:Hydroxyurea / Q000627:therapeutic use; D015994:Incidence; D019469:Indinavir / Q000627:therapeutic use; D009316:National Institutes of Health (U.S.); D010195:Pancreatitis / Q000453:epidemiology*; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use; D018119:Stavudine / Q000627:therapeutic use; D014481:United States / Q000453:epidemiology
chemical_list: D018894:Reverse Transcriptase Inhibitors; D019469:Indinavir; D018119:Stavudine; D016049:Didanosine; D006918:Hydroxyurea