Back to resultsA Study to Determine Effective Prophylaxis and Treatment of Nelfinavir-Associated Diarrhea
Primary Purpose
Diarrhea
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Calcium Carbonate
nelfinavir
lamivudine
loperamide
Calcium carbonate not administered
nelfinavir
lamivudine + zidovudine
Sponsored by
About this trial
This is an interventional prevention trial for Diarrhea
Eligibility 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
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Number of patients who experienced protocol-defined diarrhea in each treatment group during study
Secondary Outcome Measures
Time to first occurrence of protocol-defined diarrhea
The outcome of calcium carbonate plus loperamide in treating subjects who experienced diarrhea
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
Safety evaluations including physical exam, weight and vital signs measurements
Safety assessment of laboratory parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00650637
Brief Title
A Study to Determine Effective Prophylaxis and Treatment of Nelfinavir-Associated Diarrhea
Official Title
A Randomized, Open-Label, Third-Party Blinded Study for the Prophylaxis and Treatment of Nelfinavir-associated Diarrhea
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Terminated
Why Stopped
The study was prematurely discontinued due to administrative reasons on August 18, 2003. There were no safety concerns that led to the decision to terminate.
Study Start Date
January 2003 (undefined)
Primary Completion Date
August 2003 (Actual)
Study Completion Date
August 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Calcium Carbonate
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
nelfinavir
Other Intervention Name(s)
Viracept
Intervention Description
1250 mg twice a day
Intervention Type
Drug
Intervention Name(s)
lamivudine
Intervention Description
lamivudine 150 mg/zidovudine 300 mg twice a day (or stavudine 40 mg twice a day plus lamivudine 150 mg twice a day);
Intervention Type
Drug
Intervention Name(s)
loperamide
Intervention Description
If diarrhea develops, loperamide 2 mg oral caplet 3 times weekly;
Intervention Type
Other
Intervention Name(s)
Calcium carbonate not administered
Intervention Description
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);
Intervention Type
Drug
Intervention Name(s)
nelfinavir
Other Intervention Name(s)
Viracept
Intervention Description
nelfinavir 1250 mg twice a day
Intervention Type
Drug
Intervention Name(s)
lamivudine + zidovudine
Intervention Description
lamivudine 150 mg/zidovudine 300 mg twice a day (or stavudine 40 mg twice a day plus lamivudine 150 mg twice a day);
Primary Outcome Measure Information:
Title
Number of patients who experienced protocol-defined diarrhea in each treatment group during study
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Time to first occurrence of protocol-defined diarrhea
Title
The outcome of calcium carbonate plus loperamide in treating subjects who experienced diarrhea
Time Frame
Weeks 2, 4, 6, 8, and 12
Title
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
Title
Safety evaluations including physical exam, weight and vital signs measurements
Time Frame
Screening, baseline, Weeks 2, 4, 6, 8, and 12
Title
Safety assessment of laboratory parameters
Time Frame
Screening, baseline, Weeks 4, 8, and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Pfizer Investigational Site
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Pfizer Investigational Site
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Pfizer Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4301004&StudyName=A%20Study%20to%20Determine%20Effective%20Prophylaxis%20and%20Treatment%20of%20Nelfinavir-Associated%20Diarrhea.
Description
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A Study to Determine Effective Prophylaxis and Treatment of Nelfinavir-Associated Diarrhea
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