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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-02-29

Brief Summary

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

Detailed Description

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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.

Conditions

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Cryptosporidiosis HIV Infections

Keywords

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

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Nitazoxanide

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Julie Ryner

Tampa, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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RM-NTZ-99-003

Identifier Type: -

Identifier Source: secondary_id

253C