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

NCT00002444 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2005-06-24

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

DRUG

Nitazoxanide

Sponsors & Collaborators

  • Unimed Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Rosemary Soave

Study Design

Purpose
TREATMENT

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1995-10-31
Completion
1996-02-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00002444 on ClinicalTrials.gov