NCT00002158

Brief Summary

The purpose of this study is to see if nitazoxanide (NTZ) can be used to treat AIDS patients suffering from cryptosporidiosis (diarrhea caused by the parasite Cryptosporidium).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

July 10, 2007

Status Verified

July 1, 2007

First QC Date

November 2, 1999

Last Update Submit

July 9, 2007

Conditions

CryptosporidiosisHIV Infections

Keywords

CryptosporidiosisDiarrheaAcquired Immunodeficiency SyndromenitazoxanideAntiparasitic Agents

Interventions

NitazoxanideDRUG

Eligibility Criteria

Age3 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients may be eligible for this study if they:
  • Are 3 to 65 years old (need consent of parent or guardian if under 18).
  • Have AIDS.
  • Have a CD4 count less than or equal to 200 cells/mm3. (Note: Patients with a CD4 count greater than 200 cells/mm3 but who have had cryptosporidiosis for at least 4 weeks may be eligible for this study.)
  • Test positive for the parasite Cryptosporidium and have severe diarrhea (at least 4 bowel movements per day) for at least 2 weeks.
  • Have received treatment for cryptosporidiosis but have become reinfected after treatment.
  • Agree to practice abstinence or use effective methods of birth control (such as a condom) before and during the study.

You may not qualify if:

  • Patients will not be eligible for this study if they:
  • Are pregnant.
  • Are infected with certain other parasites.
  • Have a history of certain intestinal diseases.
  • Have received certain medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Romark Laboratories LC

Tampa, Florida, 33607, United States

Location

MeSH Terms

Conditions

CryptosporidiosisHIV InfectionsDiarrheaAcquired Immunodeficiency Syndrome

Interventions

nitazoxanide

Condition Hierarchy (Ancestors)

Intestinal Diseases, ParasiticParasitic DiseasesInfectionsProtozoan Infections, AnimalParasitic Diseases, AnimalCoccidiosisProtozoan InfectionsIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesAnimal DiseasesBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsSlow Virus Diseases

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

July 10, 2007

Record last verified: 2007-07

Locations

US(1)