Safety and Effectiveness of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients - Full Text View

Sponsored by:	Romark Laboratories L.C.
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00004986

Purpose

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

Condition	Intervention	Phase
Cryptosporidiosis HIV Infections	Drug: Nitazoxanide	Phase III

MedlinePlus related topics: AIDS Cryptosporidiosis

Drug Information available for: Nitazoxanide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Safety Study
Official Title:	Open Label, Multi-Center Evaluation of Nitazoxanide for the Treatment of Cryptosporidiosis in Subjects With AIDS in the United States

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:	30
Study Start Date:	February 2000

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.

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004986

Locations

United States, Florida
Julie Ryner
Tampa, Florida, United States, 33607

Sponsors and Collaborators

Romark Laboratories L.C.

More Information

Study ID Numbers:	253C, RM-NTZ-99-003
Study First Received:	March 16, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004986
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

AIDS-Related Opportunistic Infections
Cryptosporidiosis
Drug Evaluation

Antiprotozoal Agents
Treatment Failure
nitazoxanide

Study placed in the following topic categories:

Protozoan Infections
Opportunistic Infections
Sexually Transmitted Diseases, Viral
Gastrointestinal Diseases
Acquired Immunodeficiency Syndrome
Intestinal Diseases
Immunologic Deficiency Syndromes
Virus Diseases
Cryptosporidiosis

Digestive System Diseases
HIV Infections
AIDS-Related Opportunistic Infections
Sexually Transmitted Diseases
Parasitic Diseases
Nitazoxanide
Intestinal Diseases, Parasitic
Retroviridae Infections

Additional relevant MeSH terms:

Anti-Infective Agents
Antiparasitic Agents
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Coccidiosis

Therapeutic Uses
Lentivirus Infections
Parasitic Diseases, Animal
Protozoan Infections, Animal
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009