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

Phase 3

Terminated

• Conditions: Diarrhea
• Interventions: Drug: Calcium Carbonate; Other: Calcium carbonate not administered; Drug: nelfinavir; Drug: lamivudine + zidovudine; Drug: lamivudine; Drug: loperamide

• Registration Number: NCT00650637
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2003-08
• Study Completion: 2003-08
• Study First Submitted: 2008-03-31
• Study First Submitted QC: 2008-04-01
• Study First Posted: 2008-04-02
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-03
• Last Update Posted: 2011-06-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Calcium Carbonate	-
1	nelfinavir	-
2	Calcium carbonate not administered	-
2	lamivudine + zidovudine	-
1	lamivudine	-
1	loperamide	-
2	nelfinavir	-

Primary Outcome Measures

Name	Time	Method
Number of patients who experienced protocol-defined diarrhea in each treatment group during study	Week 12

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Houston, Texas, United States