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

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35233 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diarrhea
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00650637
Pfizer
Terminated
A Study to Determine Effective Prophylaxis and Treatment of Nelfinavir-Associated Diarrhea

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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 SummaryThe 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 DescriptionNot 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 DateAugust 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 CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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