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Trial record 1 of 1 for:    NCT00650637
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A Study to Determine Effective Prophylaxis and Treatment of Nelfinavir-Associated Diarrhea

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ClinicalTrials.gov Identifier: NCT00650637
Recruitment Status : 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.)
First Posted : April 2, 2008
Last Update Posted : June 8, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE March 31, 2008
First Posted Date  ICMJE April 2, 2008
Last Update Posted Date June 8, 2011
Study Start Date  ICMJE January 2003
Actual Primary Completion Date August 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2008)
Number of patients who experienced protocol-defined diarrhea in each treatment group during study [ Time Frame: Week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2008)
  • Time to first occurrence of protocol-defined diarrhea
  • The outcome of calcium carbonate plus loperamide in treating subjects who experienced diarrhea [ Time Frame: 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 [ Time Frame: Weeks 2, 4, 6, 8, and 12 ]
  • Safety evaluations including physical exam, weight and vital signs measurements [ Time Frame: Screening, baseline, Weeks 2, 4, 6, 8, and 12 ]
  • Safety assessment of laboratory parameters [ Time Frame: Screening, baseline, Weeks 4, 8, and 12 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Determine Effective Prophylaxis and Treatment of Nelfinavir-Associated Diarrhea
Official Title  ICMJE A Randomized, Open-Label, Third-Party Blinded Study for the Prophylaxis and Treatment of Nelfinavir-associated Diarrhea
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Diarrhea
Intervention  ICMJE
  • 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;
  • 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);
Study Arms  ICMJE
  • Experimental: 1
    Interventions:
    • Drug: Calcium Carbonate
    • Drug: nelfinavir
    • Drug: lamivudine
    • Drug: loperamide
  • Experimental: 2
    Interventions:
    • Other: Calcium carbonate not administered
    • Drug: nelfinavir
    • Drug: lamivudine + zidovudine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 3, 2011)
17
Original Actual Enrollment  ICMJE
 (submitted: April 1, 2008)
150
Actual Study Completion Date  ICMJE August 2003
Actual Primary Completion Date August 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00650637
Other Study ID Numbers  ICMJE A4301004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP