Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002385
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Fozivudine Tidoxil in HIV-1 Infected Patients
Sponsor:
Anderson Clinical Research
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Multicenter Rising Multiple-Dose Placebo-Controlled Dose-Response Study to Evaluate the Safety Tolerability and Anti-Viral Activity of 4 Weeks of Treatment With 200-800 Mg Fozivudine Tidoxil in Patients With HIV-1 Infection MF4314
Status:
COMPLETED
Status Verified Date:
1999-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 96ACR-BRM1 | None | None | None |
| MF4314 | None | None | None |