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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diarrhea | Drug: Calcium Carbonate Drug: nelfinavir Drug: lamivudine Drug: loperamide Other: Calcium carbonate not administered Drug: lamivudine + zidovudine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 17 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | A Randomized, Open-Label, Third-Party Blinded Study for the Prophylaxis and Treatment of Nelfinavir-associated Diarrhea |
Study Start Date : | January 2003 |
Actual Primary Completion Date : | August 2003 |
Actual Study Completion Date : | August 2003 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
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;
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Experimental: 2 |
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);
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- Number of patients who experienced protocol-defined diarrhea in each treatment group during study [ Time Frame: Week 12 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00650637
United States, Alabama | |
Pfizer Investigational Site | |
Birmingham, Alabama, United States, 35233 | |
United States, Florida | |
Pfizer Investigational Site | |
Ft. Lauderdale, Florida, United States, 33308 | |
United States, New York | |
Pfizer Investigational Site | |
New York, New York, United States, 10011 | |
United States, North Carolina | |
Pfizer Investigational Site | |
Huntersville, North Carolina, United States, 28078 | |
United States, Texas | |
Pfizer Investigational Site | |
Austin, Texas, United States, 78705 | |
Pfizer Investigational Site | |
Houston, Texas, United States, 77098 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
ClinicalTrials.gov Identifier: | NCT00650637 History of Changes |
Other Study ID Numbers: |
A4301004 |
First Posted: | April 2, 2008 Key Record Dates |
Last Update Posted: | June 8, 2011 |
Last Verified: | June 2011 |
Additional relevant MeSH terms:
Diarrhea Signs and Symptoms, Digestive Signs and Symptoms Calcium, Dietary Lamivudine Zidovudine Lamivudine, zidovudine drug combination Nelfinavir Calcium Carbonate Loperamide Antidiarrheals Bone Density Conservation Agents Physiological Effects of Drugs |
Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Antimetabolites Antacids Gastrointestinal Agents HIV Protease Inhibitors Protease Inhibitors |