A Safety and Dose-Determining Study of CMX001 In Infants With Neonatal Herpes Simplex Virus (HSV) Infection Involving the Central Nervous System (CNS Disease)

Phase 1/2 Withdrawn University of Alabama at Birmingham

RandomizedParallel-groupTriple-blindTreatment

Summary

This study is to identify if a Novel Antiviral Drug could be used to treat babies with Herpes Simplex Virus (HSV) with central nervous system (CNS) disease. In this study the investigators will identify the best dose for young children as well as identify additional safety information about the Novel Antiviral Drug.

Timeline

Start: 2016-01
Primary completion: 2017-06
Completion: 2017-06

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Brincidofovir	Other / unclassified	0.25 mg/kg	Oral
Comparator	Brincidofovir	Other / unclassified	0.5 mg/kg	Oral
Comparator	Brincidofovir	Other / unclassified	1 mg/kg	Oral
Comparator	Brincidofovir	Other / unclassified	2 mg/kg	Oral

A Safety and Dose-Determining Study of CMX001 In Infants With Neonatal Herpes Simplex Virus (HSV) Infection Involving the Central Nervous System (CNS Disease)

Summary

Timeline

Drugs

Indications