Safety and Effectiveness of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients

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Primary Purpose

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Nitazoxanide

About this trial

This is an interventional treatment trial for Cryptosporidiosis focused on measuring AIDS-Related Opportunistic Infections, Cryptosporidiosis, Drug Evaluation, Antiprotozoal Agents, Treatment Failure, nitazoxanide

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria 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. Exclusion Criteria 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.

Sites / Locations

Julie Ryner

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004986

First Posted

March 16, 2000

Last Updated

June 23, 2005

Sponsor

Romark Laboratories L.C.

1. Study Identification

Unique Protocol Identification Number

NCT00004986

Brief Title

Safety and Effectiveness of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients

Official Title

Open Label, Multi-Center Evaluation of Nitazoxanide for the Treatment of Cryptosporidiosis in Subjects With AIDS in the United States

Study Type

Interventional

2. Study Status

Record Verification Date

August 2000

Overall Recruitment Status

Terminated

Study Start Date

February 2000 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Romark Laboratories L.C.

4. Oversight

5. Study Description

Brief Summary

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

Detailed Description

Patients take nitazoxanide daily for 8 weeks with a dose escalation after the first 4 weeks. Patients return to the hospital for examinations every 2 weeks during the 8-week treatment period and 6-week follow-up. Nitazoxanide therapy is discontinued in patients showing a complete clinical and parasitologic response (therapeutic cure) after 8 weeks of treatment and in patients showing a therapeutic cure at two consecutive visits (Weeks 2 and 4 or Weeks 4 and 6). These patients undergo a physical examination including stool analysis for Cryptosporidium parvum oocysts and routine laboratory tests at Weeks 2, 4, and 6 after completion of nitazoxanide therapy. Patients who do not show a complete clinical and parasitologic response (therapeutic failure) after 8 weeks of treatment are allowed to remain on nitazoxanide therapy through the Open Label Compassionate Use of Nitazoxanide in Treatment of Cryptosporidiosis in AIDS Patients (UMD-95-009) protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cryptosporidiosis, HIV Infections

Keywords

AIDS-Related Opportunistic Infections, Cryptosporidiosis, Drug Evaluation, Antiprotozoal Agents, Treatment Failure, nitazoxanide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Enrollment

30 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Nitazoxanide

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria 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. Exclusion Criteria 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.

Facility Information:

Facility Name

Julie Ryner

City

Tampa

State/Province

Florida

ZIP/Postal Code

33607

Country

United States

Cryptosporidiosis, HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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