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

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Diarrhea

Treatments: Drug: Calcium Carbonate; Drug: lamivudine; Drug: loperamide; Other: Calcium carbonate not administered; Drug: nelfinavir; Drug: lamivudine + zidovudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00650637

A4301004

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: nelfinavir

Drug: loperamide

Drug: lamivudine

Drug: Calcium Carbonate

Drug: nelfinavir

2

Experimental group

Treatment:

Drug: lamivudine + zidovudine

Drug: nelfinavir

Other: Calcium carbonate not administered

Drug: nelfinavir