A Study to Determine Effective Prophylaxis and Treatment of Nelfinavir-Associated Diarrhea

• Status: Terminated
• Trial end date: 2003-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to determine the efficacy and safety of calcium carbonate for the prevention of nelfinavir-associated diarrhea and to evaluate the efficacy and safety of calcium carbonate in combination with loperamide for the treatment of nelfinavir-associated diarrhea.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Antidiarrheals; Calcium; Calcium Carbonate; Calcium, Dietary; Lamivudine; Lamivudine, zidovudine drug combination; Loperamide; Nelfinavir; Zidovudine

Criteria

Inclusion Criteria:

• Antiretroviral-naive patients with HIV-1 infection

• not more than 2 loose stools per day or any preexisting or emerging medical condition that would interfere with the evaluation of therapeutic response of the study drug

• No antidiarrheal medication within 7 days prior to entry

Exclusion Criteria:

• Greater than or equal to 2 loose stools per day lasting 2 or more days within 7 days prior to study entry

• Bloody stools within 7 days prior to study entry

• Any unstable or severe intercurrent medical condition, including active opportunistic infections