Effectiveness of step-wise intervention plan for managing nelfinavir-associated diarrhea: a pilot study.
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.
Rachlis
Anita
A
Sunnybrook and Women's College Health Sciences Centre, University of Toronto, Ontario, Canada. a.rachlis@utoronto.ca
Gill
John
J
Baril
Jean-Guy
JG
LeBlanc
Roger P
RP
Trottier
Benoit
B
MacLeod
John
J
Walmsley
Sharon
S
Van der Vliet
Wanda
W
Belsky
Gregory
G
Burgoyne
Robert
R
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
D000930:Antidiarrheals; D017320:HIV Protease Inhibitors; D008139:Loperamide; D002119:Calcium Carbonate; D019888:Nelfinavir