Clinical trialNCT01610765WithdrawnPhase 1/PHASE2Interventional

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

SponsorUniversity of Alabama at BirminghamEnrollment0Herpes Simplex Virus

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

David W Kimberlin, MD
University of Alabama at Birmingham
Principal Investigator
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Richard Whitley, MD
University of Alabama at Birmingham
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

18 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
University of Colorado at Denver Health Sciences Center
Aurora, Colorado, United States
Children'S National Medical Center
Washington D.C., District of Columbia, United States
University of South Florida School of Medicine
Tampa, Florida, United States
Emory Children'S Center
Atlanta, Georgia, United States
Louisiana State University Health Science Center -Shreveport
Shreveport, Louisiana, United States
Washington University in St Louis School of Medicine
St Louis, Missouri, United States
Dartmouth Medical School
Lebanon, New Hampshire, United States
Steven & Alexandra Cohen Children'S Medical Center of New York (ccmc)
Manhasset, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Carolinas Medical Center - Charlotte
Charlotte, North Carolina, United States
Metrohealth Medical Center
Cleveland, Ohio, United States
Children'S Hospital of Pittsburgh of Upmc
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas-Southwestern
Dallas, Texas, United States
University of Utah School of Medicine
Salt Lake City, Utah, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Novel Antiviral DrugPlacebo

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Jan 2016
Primary completion: 30 Jun 2017
Completion: 30 Jun 2017
Last update posted: 7 Jun 2016
Registered enrollment: 0
Registry id: NCT01610765

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.