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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.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who experienced protocol-defined diarrhea in each treatment group during study | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Birmingham | Alabama | 35233 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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|
| nelfinavir | Drug | 1250 mg twice a day |
|
|
| 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); |
|
| loperamide | Drug | If diarrhea develops, loperamide 2 mg oral caplet 3 times weekly; |
|
| 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); |
|
| nelfinavir | Drug | nelfinavir 1250 mg twice a day |
|
|
| 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); |
|
| 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 |
| Fort Lauderdale |
| Florida |
| 33308 |
| United States |
| Pfizer Investigational Site | New York | New York | 10011 | United States |
| Pfizer Investigational Site | Huntersville | North Carolina | 28078 | United States |
| Pfizer Investigational Site | Austin | Texas | 78705 | United States |
| Pfizer Investigational Site | Houston | Texas | 77098 | United States |
| ID | Term |
|---|---|
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002119 | Calcium Carbonate |
| D019888 | Nelfinavir |
| D019259 | Lamivudine |
| D008139 | Loperamide |
| C109078 | lamivudine, zidovudine drug combination |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D008903 | Minerals |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
| D010880 | Piperidines |
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