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

Study Description

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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 carbonate in combination with loperamide for the treatment of nelfinavir-associated diarrhea.

Condition or disease	Intervention/treatment	Phase
Diarrhea	Drug: Calcium Carbonate; Drug: nelfinavir; Drug: lamivudine; Drug: loperamide; Other: Calcium carbonate not administered; Drug: lamivudine + zidovudine	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	17 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	A Randomized, Open-Label, Third-Party Blinded Study for the Prophylaxis and Treatment of Nelfinavir-associated Diarrhea
Study Start Date :	January 2003
Actual Primary Completion Date :	August 2003
Actual Study Completion Date :	August 2003

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 1	Drug: Calcium Carbonate; Calcium carbonate 500 mg oral tablet twice a day; given in combination with the following antiretroviral combination: nelfinavir 1250 mg twice a day, and lamivudine 150 mg/zidovudine 300 mg twice a day (or stavudine 40 mg twice a day plus lamivudine 150 mg twice a day); If diarrhea develops, loperamide 2 mg oral caplet 3 times weekly; All study drugs continued through to Week 12 Drug: nelfinavir; 1250 mg twice a day; Other Name: Viracept Drug: lamivudine; lamivudine 150 mg/zidovudine 300 mg twice a day (or stavudine 40 mg twice a day plus lamivudine 150 mg twice a day); Drug: loperamide; If diarrhea develops, loperamide 2 mg oral caplet 3 times weekly;
Experimental: 2	Other: Calcium carbonate not administered; Prophylaxis with calcium carbonate not administered in this group; The following antiretroviral combination was administered: nelfinavir 1250 mg twice a day, and lamivudine 150 mg/zidovudine 300 mg twice a day (or stavudine 40 mg twice a day plus lamivudine 150 mg twice a day); Drug: nelfinavir; nelfinavir 1250 mg twice a day; Other Name: Viracept Drug: lamivudine + zidovudine; lamivudine 150 mg/zidovudine 300 mg twice a day (or stavudine 40 mg twice a day plus lamivudine 150 mg twice a day);

Outcome Measures

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Primary Outcome Measures :

1. Number of patients who experienced protocol-defined diarrhea in each treatment group during study [ Time Frame: Week 12 ]

Secondary Outcome Measures :

1. Time to first occurrence of protocol-defined diarrhea
2. The outcome of calcium carbonate plus loperamide in treating subjects who experienced diarrhea [ Time Frame: Weeks 2, 4, 6, 8, and 12 ]
3. Frequency and severity of diarrhea collected from the subject daily diary during the study will be summarized before and after subjects receive calcium carbonate plus loperamide [ Time Frame: Weeks 2, 4, 6, 8, and 12 ]
4. Safety evaluations including physical exam, weight and vital signs measurements [ Time Frame: Screening, baseline, Weeks 2, 4, 6, 8, and 12 ]
5. Safety assessment of laboratory parameters [ Time Frame: Screening, baseline, Weeks 4, 8, and 12 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233
United States, Florida
Pfizer Investigational Site
Ft. Lauderdale, Florida, United States, 33308
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10011
United States, North Carolina
Pfizer Investigational Site
Huntersville, North Carolina, United States, 28078
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78705
Pfizer Investigational Site
Houston, Texas, United States, 77098

Sponsors and Collaborators

Pfizer

Investigators

Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00650637 History of Changes
Other Study ID Numbers:	A4301004
First Posted:	April 2, 2008
Last Update Posted:	June 8, 2011
Last Verified:	June 2011

Additional relevant MeSH terms:

Diarrhea; Signs and Symptoms, Digestive; Signs and Symptoms; Calcium, Dietary; Lamivudine; Zidovudine; Lamivudine, zidovudine drug combination; Nelfinavir; Calcium Carbonate; Loperamide; Antidiarrheals; Bone Density Conservation Agents; Physiological Effects of Drugs	Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents; Anti-HIV Agents; Antimetabolites; Antacids; Gastrointestinal Agents; HIV Protease Inhibitors; Protease Inhibitors