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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diarrhea

Intervention / Treatment
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* Drug: Calcium Carbonate
* Drug: nelfinavir
* Drug: lamivudine
* Drug: loperamide
* Other: Calcium carbonate not administered
* Drug: nelfinavir
* Drug: lamivudine + zidovudine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Calcium Carbonate<br>* 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<br>Drug: nelfinavir<br>* 1250 mg twice a day<br>* Other names: Viracept;Drug: lamivudine<br>* lamivudine 150 mg/zidovudine 300 mg twice a day (or stavudine 40 mg twice a day plus lamivudine 150 mg twice a day);<br>Drug: loperamide<br>* If diarrhea develops, loperamide 2 mg oral caplet 3 times weekly;<br>|
| Experimental: 2<br> | Other: Calcium carbonate not administered<br>* 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);<br>Drug: nelfinavir<br>* nelfinavir 1250 mg twice a day<br>* Other names: Viracept;Drug: lamivudine + zidovudine<br>* lamivudine 150 mg/zidovudine 300 mg twice a day (or stavudine 40 mg twice a day plus lamivudine 150 mg twice a day);<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who experienced protocol-defined diarrhea in each treatment group during study |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |