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

NCT00650637 | Terminated Phase 3 DMC

• 1 other identifier: A4301004
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 6

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.

Conditions

Diarrhea

Outcome Measures

Primary Outcomes (1)

• Number of patients who experienced protocol-defined diarrhea in each treatment group during study

  Week 12

Secondary Outcomes (5)

• Time to first occurrence of protocol-defined diarrhea

• The outcome of calcium carbonate plus loperamide in treating subjects who experienced diarrhea

  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

  Weeks 2, 4, 6, 8, and 12

• Safety evaluations including physical exam, weight and vital signs measurements

  Screening, baseline, Weeks 2, 4, 6, 8, and 12

• Safety assessment of laboratory parameters

  Screening, baseline, Weeks 4, 8, and 12

Study Arms (2)

1

EXPERIMENTAL

Drug: Calcium Carbonate; Drug: nelfinavir; Drug: lamivudine; Drug: loperamide

2

EXPERIMENTAL

Other: Calcium carbonate not administered; Drug: nelfinavir; Drug: lamivudine + zidovudine

Interventions

Calcium Carbonate DRUG

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

1

nelfinavir DRUG

1250 mg twice a day

Also known as: Viracept

1

lamivudine DRUG

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

1

loperamide DRUG

If diarrhea develops, loperamide 2 mg oral caplet 3 times weekly;

1

Calcium carbonate not administered OTHER

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);

2

lamivudine + zidovudine DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (6)

Pfizer Investigational Site

Birmingham, Alabama, 35233, United States

Location

Pfizer Investigational Site

Fort Lauderdale, Florida, 33308, United States

Location

Pfizer Investigational Site

New York, New York, 10011, United States

Location

Pfizer Investigational Site

Huntersville, North Carolina, 28078, United States

Location

Pfizer Investigational Site

Austin, Texas, 78705, United States

Location

Pfizer Investigational Site

Houston, Texas, 77098, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Diarrhea

Interventions

Calcium Carbonate; Nelfinavir; Lamivudine; Loperamide; lamivudine, zidovudine drug combination

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Piperidines

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 2, 2008
• Study Start: January 1, 2003
• Primary Completion: August 1, 2003
• Study Completion: August 1, 2003
• Last Updated: June 8, 2011

Record last verified: 2011-06

Locations

US (6)