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To identify doses of fozivudine tidoxil that are well tolerated and produce measurable antiviral activity.
To identify the adverse event profile that defines the maximum tolerated dose. To characterize the single- and multiple-dose pharmacokinetics of fozivudine and its metabolites.
To correlate the adverse event profile and antiviral activity of fozivudine with pharmacokinetic parameters.
Full description
In this double-blind, dose-escalating study, patients receive fozivudine tidoxil at one of 5 dosage levels for 4 weeks and are randomized with respect to once- or twice-daily administration (cohorts 2 vs. 3 and 4 vs. 5). Within each cohort, 10 patients are randomized to the study drug and 2 to the placebo. At least 9 of the 12 patients enrolled in Cohort 1 must complete the entire 4-week course before Cohorts 2 and 3 are enrolled. At least 18 of these 24 patients must complete 2 weeks of the 4-week course before Cohorts 4 and 5 are enrolled.
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Inclusion and exclusion criteria
Inclusion Criteria
Concurrent Medication:
Allowed:
Primary and secondary prophylaxis for opportunistic infection if stable and initiated at least 3 months prior to study drug administration.
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Systemic therapy for malignancy.
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
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Data sourced from clinicaltrials.gov
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