A Randomized, Open-Label, Third-Party Blinded Study for the Prophylaxis and Treatment of Nelfinavir-associated Diarrhea

Pfizer1 site in 1 country17 target enrollmentJanuary 2003

InterventionsCalcium Carbonate nelfinavir lamivudine loperamide Calcium carbonate not administered lamivudine + zidovudine

DrugsCalcium Carbonate nelfinavir lamivudine loperamide lamivudine + zidovudine

Overview

Phase: Phase 3
Intervention: Calcium Carbonate
Conditions: Diarrhea
Sponsor: Pfizer
Enrollment: 17
Locations: 1
Primary Endpoint: Number of patients who experienced protocol-defined diarrhea in each treatment group during study
Status: Terminated
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2003

End Date

August 2003

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

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

Arms & Interventions

1

Intervention: Calcium Carbonate

1

Intervention: nelfinavir

1

Intervention: lamivudine

1

Intervention: loperamide

2

Intervention: Calcium carbonate not administered

2

Intervention: nelfinavir

2

Intervention: lamivudine + zidovudine

Outcomes

Primary Outcomes

Number of patients who experienced protocol-defined diarrhea in each treatment group during study

Time Frame: Week 12

Secondary Outcomes

Time to first occurrence of protocol-defined diarrhea
The outcome of calcium carbonate plus loperamide in treating subjects who experienced diarrhea(Weeks 2, 4, 6, 8, and 12)
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(Weeks 2, 4, 6, 8, and 12)
Safety evaluations including physical exam, weight and vital signs measurements(Screening, baseline, Weeks 2, 4, 6, 8, and 12)
Safety assessment of laboratory parameters(Screening, baseline, Weeks 4, 8, and 12)