A Study to Evaluate the Use of Nitazoxanide to Treat Cryptosporidiosis

NCT ID: NCT00002158

Last Updated: 2007-07-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL

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).

Detailed Description

Patients receive oral nitazoxanide daily for 14 days, after which those with complete clinical and parasitologic response discontinue treatment. Non-responders and partial responders may continue therapy for an additional 14 days at the discretion of the physician. Non-responders who show signs of improvement or who have partial response after 28 days and those who relapse following complete response may continue therapy for an additional month, up to 60 days total. [AS PER AMENDMENT 10/30/96: Patients receive a daily treatment for 4 weeks, with subsequent dose escalation in the absence of drug-related toxicity. Patients who exhibit complete response after 2 months may continue at a maintenance dose. Patients enrolled after October 15, 1996 are randomized to 1 of 2 doses, with subsequent escalations made in the absence of toxicity. Complete responders may continue therapy at a maintenance dose and duration determined by the investigator. Non-responders after 6 months of therapy have treatment discontinued.] [AS PER AMENDMENT 8/5/97: All patients are evaluated at Weeks 1, 2, 4, and monthly thereafter.] [AS PER AMENDMENT 8/17/99: New patients start therapy on a different dosage of nitazoxanide. Those who do not respond after 4 weeks of therapy will escalate to a higher dosage. Patients who show a complete response at 2 consecutive visits (2 weeks apart) discontinue nitazoxanide therapy and go to follow-up.] [AS PER AMENDMENT 2/3/00: The Week 1 clinical evaluation is deleted from the study procedures.]

Conditions

Cryptosporidiosis; HIV Infections

Study Design

• Primary Study Purpose: TREATMENT

Interventions

Nitazoxanide

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Romark Laboratories L.C.

INDUSTRY

Sponsor Role: lead

Locations

Romark Laboratories LC

Tampa, Florida, United States

Countries

United States

Other Identifiers

UMD-95-009

Identifier Type: -

Identifier Source: secondary_id

253B

Identifier Type: -

Identifier Source: org_study_id