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Tolerance of FIAU in HIV-Infected Patients With Herpes Group Virus Infections
NCT00000654Phase 2
Key facts
- Status
- Completed
- Countries
- 1
- Sponsor
- National Institute of Allergy and Infectious Diseases
- Modality
- Orthosteric Ligands, Metabolically Activated Prodrugs
- Drugs
- fialuridine
- Conditions
- herpes simplex (HSV)hepatitis B (HBV)varicella zoster virus infectioncytomegalovirus infection (CMV)
01
Overview
Phase 2, open-label trial of fialuridine in herpes simplex (HSV), hepatitis B (HBV), varicella zoster virus infection and 1 more (4 cohorts), sponsored by National Institute of Allergy and Infectious Diseases. Primary endpoints: Tolerance to TID oral doses of FIAU syrup at 14 days and Peak and trough blood levels of FIAU and its metabolites at Day 14. Status: completed.
02
Design
4 arms- Study design
- Non-randomizedOpen-label
Dose Cohort 1
FIAU Dose Level 1
Dose Cohort 2
FIAU Dose Level 2
Dose Cohort 3
FIAU Dose Level 3
Dose Cohort 4
FIAU Dose Level 4
03
Who it enrols
HIV-infected outpatients with Karnofsky score >= 80, without unstable medical conditions, severe infections, or specific prior antiviral therapies.
04
Endpoints
Primary
Tolerance to TID oral doses of FIAU syrup
Peak and trough blood levels of FIAU and its metabolites
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