NCT00000654|CompletedPhase 2
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Sponsor study identifier
Secondary identifiers
interventional
78
1 country
4
Study Start
Not reported
Date not reportedPrimary Completion
Not reported
Date not reportedStudy Completion
February 1993
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1993
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 1993
Actual (reported)November 2, 1999
Actual (reported)August 31, 2001
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325, United States
Natl Institute of Health
Bethesda, Maryland, 20892, United States
Univ of Washington / Madison Clinic
Seattle, Washington, 98122, United States
Tartaglione T, Hooton TM, Jones T, Smiles K, Corey L. Actg 122: phase II tolerance study of oral FIAU in HIV-infected persons. Int Conf AIDS. 1991 Jun 16-21;7(2):254 (abstract no WB2290)
D Richman
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
February 1993
Actual (reported)Last Updated
December 18, 2012
Record last verified: 2012-12
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Source: ClinicalTrials.gov.
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