title: Effectiveness of step-wise intervention plan for managing nelfinavir-associated diarrhea: a pilot study.
abstract: OBJECTIVE
  Pilot study to evaluate the effectiveness of a step-wise diarrhea management strategy for nelfinavir-associated diarrhea.
  
  
  METHODS
  HIV-infected adults (CD4 count > 100 cells/mm3, and no evidence of enteric pathogens) developing symptoms of diarrhea after initiation of nelfinavir for a duration of > or = 1 month were enrolled into this 9-week prospective pilot study. Step-wise interventions, reviewed and adjusted additively at 2-week intervals, included nutritional counseling (+/- lactase and/or psyllium), calcium carbonate, and loperamide. Outcome measure included stool-form consistency, bowel movement frequency, and incidents of associated morbidity (urgency, incontinence) daily. Patient quality of life was also assessed.
  
  
  RESULTS
  Eighteen patients completed the study. Mean daily bowel movement frequency decreased by 32%, from 2.98 to 2.03 (p = .005). Mean daily stool form shifted from a rating of 4.24 to 2.37 (p = .0001), representing a shift to firmer stools. Period prevalence of incontinence (28%) and urgency (33%) decreased to 6% each, respectively. Quality of life ratings relating to gastrointestinal disturbance and overall physical/psychosocial function were improved.
  
  
  CONCLUSIONS
  The results of this pilot study demonstrated that a step-wise intensified approach may be successful in managing nelfinavir-associated diarrhea and will need to be validated in a larger scale, randomized controlled trial.
authors.affiliation: Sunnybrook and Women's College Health Sciences Centre, University of Toronto, Ontario, Canada. a.rachlis@utoronto.ca
authors.forename: Anita
authors.initials: A
authors.lastname: Rachlis
authors.forename: John
authors.initials: J
authors.lastname: Gill
authors.forename: Jean-Guy
authors.initials: JG
authors.lastname: Baril
authors.forename: Roger P
authors.initials: RP
authors.lastname: LeBlanc
authors.forename: Benoit
authors.initials: B
authors.lastname: Trottier
authors.forename: John
authors.initials: J
authors.lastname: MacLeod
authors.forename: Sharon
authors.initials: S
authors.lastname: Walmsley
authors.forename: Wanda
authors.initials: W
authors.lastname: Van der Vliet
authors.forename: Gregory
authors.initials: G
authors.lastname: Belsky
authors.forename: Robert
authors.initials: R
authors.lastname: Burgoyne
mesh_terms: D000293:Adolescent; D000328:Adult; D000930:Antidiarrheals / Q000008:administration & dosage; D002119:Calcium Carbonate / Q000008:administration & dosage; D003967:Diarrhea / Q000139:chemically induced / Q000473:pathology / Q000628:therapy*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D017320:HIV Protease Inhibitors / Q000009:adverse effects*; D006801:Humans; D008139:Loperamide / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D019888:Nelfinavir / Q000009:adverse effects*; D009752:Nutritional Status; D009864:Ontario; D010865:Pilot Projects; D011446:Prospective Studies; D011788:Quality of Life; D011792:Quebec; D016896:Treatment Outcome
chemical_list: D000930:Antidiarrheals; D017320:HIV Protease Inhibitors; D008139:Loperamide; D002119:Calcium Carbonate; D019888:Nelfinavir