Status:
TERMINATED
A Study to Determine Effective Prophylaxis and Treatment of Nelfinavir-Associated Diarrhea
Lead Sponsor:
Pfizer
Conditions:
Diarrhea
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 carbonat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2003
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00650637
Start Date
January 1 2003
End Date
August 1 2003
Last Update
June 8 2011
Active Locations (6)
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1
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233
2
Pfizer Investigational Site
Fort Lauderdale, Florida, United States, 33308
3
Pfizer Investigational Site
New York, New York, United States, 10011
4
Pfizer Investigational Site
Huntersville, North Carolina, United States, 28078