The Tolerance of HIV-Infected Patients With Herpes Group Virus Infections to Oral Doses of FIAU
Status:
Completed
Trial end date:
1993-02-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)