Purpose: Pilot study to evaluate the effectiveness of a step-wise diarrhea management strategy for nelfinavir-associated diarrhea.
Method: 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.
Conclusion: 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.