NCT00004986

Brief Summary

The purpose of this study is to see if it is safe and effective to treat cryptosporidiosis in AIDS patients with nitazoxanide.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2000

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 16, 2000

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

August 1, 2000

First QC Date

March 16, 2000

Last Update Submit

June 23, 2005

Conditions

CryptosporidiosisHIV Infections

Keywords

AIDS-Related Opportunistic InfectionsCryptosporidiosisDrug EvaluationAntiprotozoal AgentsTreatment Failurenitazoxanide

Interventions

NitazoxanideDRUG

Eligibility Criteria

Age13 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 HIV-positive.
  • Have a CD4 cell count of 50 cells/mm3 or less.
  • Have evidence of cryptosporidium infection in their stool sample within 10 days of study entry.
  • Have watery stools at least three times a day at least 5 days a week for 21 days prior to enrollment.
  • Are able to take medications by mouth.
  • Are at least 13 years old (consent of parent or guardian required if under 18).
  • Agree to use an effective method of birth control (such as condoms) during the study.

You may not qualify if:

  • Patients will not be eligible if they:
  • Have certain diseases or infections of the intestines.
  • Have ever taken nitazoxanide.
  • Have taken certain experimental drugs within 14 days of enrollment.
  • Will need to take certain other medications during the study such as paromomycin, azithromycin, and clarithromycin.
  • Have started a new anti-HIV therapy within 4 weeks of study entry or plan on starting one during the study.
  • Are pregnant or breast-feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Julie Ryner

Tampa, Florida, 33607, United States

Location

MeSH Terms

Conditions

CryptosporidiosisHIV InfectionsAIDS-Related Opportunistic Infections

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 DiseasesOpportunistic Infections

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 16, 2000

First Posted

August 31, 2001

Study Start

February 1, 2000

Last Updated

June 24, 2005

Record last verified: 2000-08

Locations

US(1)