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

This study has been terminated.
(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.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00650637
First received: March 31, 2008
Last updated: June 3, 2011
Last verified: June 2011
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized, Open-Label, Third-Party Blinded Study for the Prophylaxis and Treatment of Nelfinavir-associated Diarrhea

Resource links provided by NLM:


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: 17
Study Start Date: January 2003
Study Completion Date: August 2003
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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);

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00650637     History of Changes
Other Study ID Numbers: A4301004
Study First Received: March 31, 2008
Last Updated: June 3, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 29, 2014