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

Diarrhea Clinical Trial

Official title:

A Randomized, Open-Label, Third-Party Blinded Study for the Prophylaxis and Treatment of Nelfinavir-associated Diarrhea

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00650637
• Other study ID #: A4301004
• Status: Terminated
• Phase: Phase 3
• First received: March 31, 2008
• Last updated: June 3, 2011
• Start date: January 2003
• Est. completion date: August 2003

Study information

• Verified date: June 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: August 2003
• Est. primary completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diarrhea

Intervention

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
• nelfinavir
1250 mg twice a day
• lamivudine
lamivudine 150 mg/zidovudine 300 mg twice a day (or stavudine 40 mg twice a day plus lamivudine 150 mg twice a day);
• 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
• 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);

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Ft. Lauderdale	Florida
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Huntersville	North Carolina
United States	Pfizer Investigational Site	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who experienced protocol-defined diarrhea in each treatment group during study		Week 12	Yes
Secondary	Time to first occurrence of protocol-defined diarrhea			Yes
Secondary	The outcome of calcium carbonate plus loperamide in treating subjects who experienced diarrhea		Weeks 2, 4, 6, 8, and 12	Yes
Secondary	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		Weeks 2, 4, 6, 8, and 12	Yes
Secondary	Safety evaluations including physical exam, weight and vital signs measurements		Screening, baseline, Weeks 2, 4, 6, 8, and 12	Yes
Secondary	Safety assessment of laboratory parameters		Screening, baseline, Weeks 4, 8, and 12	Yes

External Links

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