NCT00002444

A Study of Nitazoxanide in the Treatment of AIDS-Related Diarrhea

Phase I/II Open Label Evaluation of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (planned)
• Sponsor: Unimed Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To determine the pharmacokinetics profile of single doses of nitazoxanide (NTZ) in patients with AIDS-related cryptosporidial diarrhea. To determine steady state concentrations of NTZ following repeated dosing. To assess the safety and efficacy of 4 dose levels of NTZ in these patients. Cryptosporidial enterocolitis in AIDS patients is frequently chronic and severe, contributing substantially to morbidity, mortality, and health care costs in this population. NTZ exhibits antimicrobial activity that may extend to Cryptosporidial infection.

Detailed description

Cryptosporidial enterocolitis in AIDS patients is frequently chronic and severe, contributing substantially to morbidity, mortality, and health care costs in this population. NTZ exhibits antimicrobial activity that may extend to Cryptosporidial infection. Patients are enrolled in groups of 7. Group A receives the lowest dose of NTZ. Groups B - D receive sequentially higher doses. Patients in Groups B - D do not begin therapy until all patients have been enrolled at the preceding dose. For determination of single-dose pharmacokinetics, patients receive a single dose of NTZ on Day 1 and blood samples are obtained over the next 24 hours. Immediately following the 24-hour blood sample collection, patients begin the treatment phase during which they take NTZ for an additional 13 days. Blood samples are obtained again on Day 14 to determine full plasma concentration-time profiles over the dosing interval. At the end of treatment, responders discontinue treatment and nonresponders continue NTZ treatment for an additional 14 days on the same dose. Patients who still fail to respond are provided with an additional month of NTZ. Patients have scheduled visits for clinical and parasitologic efficacy assessments and safety laboratory tests.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Nitazoxanide

Timeline

• Start date: 1995-10-01
• Completion: 1996-02-01
• First posted: 2001-08-31
• Last updated: 2005-06-24

Locations

1 site across 1 country: United States