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| Sponsor: | Unimed Pharmaceuticals |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002444 |
Purpose
To determine the pharmacokinetics profile of single doses of nitazoxanide (NTZ) in patients with AIDS-related cryptosporidial diarrhea. To determine steady state concentrations of NTZ following repeated dosing. To assess the safety and efficacy of 4 dose levels of NTZ in these patients.
Cryptosporidial enterocolitis in AIDS patients is frequently chronic and severe, contributing substantially to morbidity, mortality, and health care costs in this population. NTZ exhibits antimicrobial activity that may extend to Cryptosporidial infection.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Nitazoxanide |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Dose Comparison, Pharmacokinetics Study |
| Official Title: | Phase I/II Open Label Evaluation of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients |
| Estimated Enrollment: | 28 |
| Study Start Date: | October 1995 |
| Estimated Study Completion Date: | February 1996 |
Cryptosporidial enterocolitis in AIDS patients is frequently chronic and severe, contributing substantially to morbidity, mortality, and health care costs in this population. NTZ exhibits antimicrobial activity that may extend to Cryptosporidial infection.
Patients are enrolled in groups of 7. Group A receives the lowest dose of NTZ. Groups B - D receive sequentially higher doses. Patients in Groups B - D do not begin therapy until all patients have been enrolled at the preceding dose. For determination of single-dose pharmacokinetics, patients receive a single dose of NTZ on Day 1 and blood samples are obtained over the next 24 hours. Immediately following the 24-hour blood sample collection, patients begin the treatment phase during which they take NTZ for an additional 13 days. Blood samples are obtained again on Day 14 to determine full plasma concentration-time profiles over the dosing interval. At the end of treatment, responders discontinue treatment and nonresponders continue NTZ treatment for an additional 14 days on the same dose. Patients who still fail to respond are provided with an additional month of NTZ. Patients have scheduled visits for clinical and parasitologic efficacy assessments and safety laboratory tests.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Prior Medication:
Required:
Allowed:
Medication for prophylaxis or maintenance therapy of opportunistic infection, stable for at least 2 weeks prior to enrollment.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Grade 4 (hematologic) or Grade 3 (for all others) toxicity. (Patients with Grade 3 toxicity for hepatic parameters may be enrolled if, in the investigator's judgment, the abnormalities are due to biliary cryptosporidiosis.)
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Contacts and Locations
More Information
| Study ID Numbers: | 253A, UMD-95-004 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002444 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Pharmacologic Actions Immunologic Deficiency Syndromes |
Virus Diseases Antiparasitic Agents HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Nitazoxanide Retroviridae Infections |