Diarrhea
Conditions
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.
Interventions
DRUGCalcium 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
DRUGnelfinavir
1250 mg twice a day
DRUGlamivudine
lamivudine 150 mg/zidovudine 300 mg twice a day (or stavudine 40 mg twice a day plus lamivudine 150 mg twice a day);
DRUGloperamide
If diarrhea develops, loperamide 2 mg oral caplet 3 times weekly;
OTHERCalcium 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);
DRUGlamivudine + zidovudine
lamivudine 150 mg/zidovudine 300 mg twice a day (or stavudine 40 mg twice a day plus lamivudine 150 mg twice a day);
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients who experienced protocol-defined diarrhea in each treatment group during study | Week 12 |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed