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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00650637

Purpose

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	Intervention	Phase
Diarrhea	Drug: Calcium Carbonate Drug: nelfinavir Drug: lamivudine Drug: loperamide Other: Calcium carbonate not administered Drug: lamivudine + zidovudine	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Open-Label, Third-Party Blinded Study for the Prophylaxis and Treatment of Nelfinavir-Associated Diarrhea

Resource links provided by NLM:

MedlinePlus related topics: Calcium Diarrhea

Drug Information available for: Zidovudine Loperamide hydrochloride Loperamide Lamivudine Nelfinavir Nelfinavir Mesylate Calcium gluconate Calcium carbonate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Number of patients who experienced protocol-defined diarrhea in each treatment group during study [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Time to first occurrence of protocol-defined diarrhea [ Designated as safety issue: Yes ]
The outcome of calcium carbonate plus loperamide in treating subjects who experienced diarrhea [ Time Frame: Weeks 2, 4, 6, 8, and 12 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Safety evaluations including physical exam, weight and vital signs measurements [ Time Frame: Screening, baseline, Weeks 2, 4, 6, 8, and 12 ] [ Designated as safety issue: Yes ]
Safety assessment of laboratory parameters [ Time Frame: Screening, baseline, Weeks 4, 8, and 12 ] [ Designated as safety issue: Yes ]

Enrollment:	150
Study Start Date:	January 2003
Study Completion Date:	August 2003
Estimated Primary Completion Date:	August 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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 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;
2: Experimental	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 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);

Arms

Assigned Interventions

1: Experimental

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

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;

2: Experimental

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

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);

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650637

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
Houston, Texas, United States, 77098
Pfizer Investigational Site
Austin, Texas, United States, 78705

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4301004
Study First Received:	March 31, 2008
Last Updated:	October 7, 2008
ClinicalTrials.gov Identifier:	NCT00650637 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Signs and Symptoms, Digestive
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Lamivudine
Zidovudine
Bone Density Conservation Agents
Calcium Carbonate
Reverse Transcriptase Inhibitors
Signs and Symptoms
Anti-Retroviral Agents
Therapeutic Uses
Nelfinavir

Nucleic Acid Synthesis Inhibitors
HIV Protease Inhibitors
Diarrhea
Anti-HIV Agents
Gastrointestinal Agents
Loperamide
Enzyme Inhibitors
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Antidiarrheals
Calcium, Dietary
Antacids

ClinicalTrials.gov processed this record on November 27, 2009