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

PHASE3TerminatedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

January 31, 2003

Primary Completion Date

August 31, 2003

Study Completion Date

August 31, 2003

Conditions
Diarrhea
Interventions
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

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;

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

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);

Trial Locations (6)

10011

Pfizer Investigational Site, New York

28078

Pfizer Investigational Site, Huntersville

33308

Pfizer Investigational Site, Fort Lauderdale

35233

Pfizer Investigational Site, Birmingham

77098

Pfizer Investigational Site, Houston

78705

Pfizer Investigational Site, Austin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY