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NCT00000654 · ClinicalTrials.gov registry record · Phase 2
The Tolerance of HIV-Infected Patients With Herpes Group Virus Infections to Oral Doses of FIAU
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 78
- Enrollment target
NCT00000654 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 78 participants.
The verdict
NCT00000654, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
Study Summary
To determine the tolerance of HIV-infected patients to TID oral doses of FIAU syrup at 4 different dose levels. To determine the peak and trough blood levels of FIAU and its metabolites during two weeks of oral dosing with FIAU. The pyrimidine nucleoside analog FIAC and its primary deaminated uracil metabolite FIAU are highly and specifically active compounds in vitro against several herpes group viruses, particularly herpes simplex virus (HSV) types 1 and 2, varicella zoster (VZV), and cytomegalovirus (CMV), as well as hepatitis B virus (HBV). Since FIAU is the primary metabolite of FIAC and the administration of FIAU simplifies the metabolism of FIAC, it is anticipated from clinical studies of FIAC that FIAU will be tolerated at least as well as FIAC. A single-dose, pharmacokinetic (blood level) study showed that FIAC, when taken orally, is readily absorbed into the bloodstream, and most of it is converted to FIAU. Daily oral doses are expected to provide concentrations of FIAU exceeding the in vitro minimum inhibitory concentration for nearly all the herpes group viruses.
Interventions
- DRUG Fialuridine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Est. Completion | 1993-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000654
The ClinicalTrials.gov registry entry for NCT00000654 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Fialuridine is the first listed.
NCT00000654 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00000654 about?
NCT00000654 is a clinical study titled "The Tolerance of HIV-Infected Patients With Herpes Group Virus Infections to Oral Doses of FIAU". To determine the tolerance of HIV-infected patients to TID oral doses of FIAU syrup at 4 different dose levels. To determine the peak and trough blood levels of FIAU and its metabolites during two weeks of oral dosing with FIAU. The pyrimidine nucleoside analog FIAC and its primary deaminated uraci...
What is the current status of trial NCT00000654?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 78 participants. Estimated completion is 1993-02.
What interventions are being tested in trial NCT00000654?
The interventions under investigation include: Fialuridine (DRUG).
Who is sponsoring clinical trial NCT00000654?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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