HIV Infections Clinical Trial
Official title:
Phase I/II Open Label Evaluation of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients
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.
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.
;
Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment
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