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

Stopped early · Phase 3

Conditions studied: Diarrhea

In brief

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.

Key facts

Study ID

NCT00650637

Run by

Pfizer

People needed

17

Starts

2003-01-01

Expected to finish

2003-08-01

Last updated by the study team

2011-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pfizer Investigational Site — Birmingham, Alabama, United States
• Pfizer Investigational Site — Fort Lauderdale, Florida, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — Huntersville, North Carolina, United States
• Pfizer Investigational Site — Austin, Texas, United States
• Pfizer Investigational Site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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