Official Title: “A Randomized, Open-Label, Third-Party Blinded Study for the Prophylaxis and Treatment of Nelfinavir-Associated Diarrhea”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2003

Intervention(s) in this Clinical Trial

• 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;
• 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, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2

Primary Measures

• Number of patients who experienced protocol-defined diarrhea in each treatment group during study
  • Time Frame: Week 12
    Safety Issue?: Yes

Secondary Measures

• Time to first occurrence of protocol-defined diarrhea
  • 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
    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
    Safety Issue?: Yes
• Safety evaluations including physical exam, weight and vital signs measurements
  • Time Frame: Screening, baseline, Weeks 2, 4, 6, 8, and 12
    Safety Issue?: Yes
• Safety assessment of laboratory parameters
  • Time Frame: Screening, baseline, Weeks 4, 8, and 12
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00650637

Study ID Number: A4301004

ClinicalTrials.gov Identifier: NCT00650637

Health Authority: United States: Food and Drug Administration

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Link to ClinicalStudyResults.org