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



Status:Withdrawn
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:6/8/2016
Start Date:January 2016
End Date:June 2017

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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.

In this study, the pharmacokinetics and safety of a Novel Antiviral Drug will be determined
in babies with neonatal HSV CNS disease. The study will be conducted at 18 academic medical
centers throughout the United States. Young infants presenting with virologic confirmation
of neonatal HSV infection and evidence of CNS involvement will be eligible for study
enrollment. Study Day 1 is defined as the day when dose 1 of the Novel Antiviral Drug study
medication is administered.

Inclusion Criteria:

- Signed Informed Consent by parent or legal guardian of study subject

- Virologically confirmed HSV infection [e.g., positive culture, DNA detection by
polymerase chain reaction (PCR), or direct fluorescent antibody stain from any body
site or compartment]

- Evidence of CNS involvement of HSV disease [e.g., CSF pleocytosis, positive CSF PCR
testing, clinical or electroencephalogram (EEG) seizure activity, neuroimaging
abnormality)

- Starting parenteral acyclovir therapy at time of initiation of CMX001 study drug or
receiving parenteral acyclovir therapy for ≤ 72 hours before start CMX001 study drug

- ≤ 6 weeks (42 days) of age at time of initial onset of disease symptoms or signs

- Weight at study enrollment ≥ 2,630 grams

- Gestational age ≥ 36 weeks at delivery

- Mother tested negative for HIV during or following pregnancy

Exclusion Criteria:

- Imminent demise

- Disseminated or skin/eye/mouth (SEM) neonatal HSV disease classifications

- Gastrointestinal abnormality which might preclude absorption of an oral medication
(e.g., history of necrotizing enterocolitis, gastroschisis, malrotation, etc.)

- Birth weight < 2,500 grams

- Birth weight > 4,500 grams

- Grade 3 or 4 vomiting, utilizing the DAIDS Toxicity Tables (Appendix B)

- Grade 3 or 4 diarrhea, utilizing the DAIDS Toxicity Tables (Appendix B)

- Creatinine clearance < 15 mL/min/1.73m2

- Serum albumin < 2.0 g/dL

- Alanine aminotransferase (ALT) ≥ 2.6-times upper limit normal (ULN)

- Aspartate aminotransferase (AST) ≥ 2.6-times upper limit normal (ULN)

- Direct bilirubin > 2 mg/dL

- Known immunodeficiency

- Known congenital infection (e.g., symptomatic congenital cytomegalovirus infection;
syphilis; congenital toxoplasmosis)

- Congenital heart disease (e.g., patent ductus arteriosus, Tetralogy of Fallot,
hypoplastic left heart syndrome, AV canal, VSD, ASD, transposition of the great
arteries, hypoplastic right ventricle, truncus arteriosus, pulmonic stenosis, Ebstein
anomaly, coarctation of the aorta, interrupted aortic arch, double outlet right
ventricle, dilated cardiomyopathy)

- Infants currently receiving or anticipated to need treatment with digoxin that cannot
be withheld for the duration of CMX001 therapy

- Infants currently receiving or anticipated to need treatment with ketaconazole that
cannot be withheld for the duration of CMX001 therapy

- Receipt of investigation drugs within 30 days prior to enrollment

- Concurrent enrollment or participation in any other interventional research study
We found this trial at
18
sites
Aurora, Colorado 80045
Principal Investigator: Mark J Abzug, M.D.
Phone: 720-777-6389
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: David Kimberlin, MD
Phone: 205-934-8559
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
Principal Investigator: Jose Romero, MD
Phone: 501-364-1416
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Natasha B. Halasa, MD, MPH
Phone: 615-322-3346
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Principal Investigator: Marian G Michaels, MD, MPH
Phone: 412-692-6786
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Principal Investigator: Penelope Dennehy, MD
Phone: 401-444-8360
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Principal Investigator: Mary Caserta, M.D.
Phone: 585-275-5944
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Atlanta, Georgia 30322
Principal Investigator: Andrea Shane, MD MPH
Phone: 404-727-9880
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Charlotte, North Carolina 28203
Principal Investigator: Amina Ahmed, MD BS
Phone: 704-381-6870
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2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
Principal Investigator: Nazha F. Abughali, M.D.
Phone: 216-778-3402
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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Dallas, Texas 75390
Principal Investigator: Pablo Sanchez, MD
Phone: 214-648-3753
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Lebanon, New Hampshire 03765
Principal Investigator: Peter F Wright, MD
Phone: 603-653-6190
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Manhasset, New York 11030
Principal Investigator: Sunil Sood, MD
Phone: 516-562-3957
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Salt Lake City, Utah 84132
Principal Investigator: Kwabena Ampofo, MD
Phone: 801-581-6791
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Shreveport, Louisiana 71130
Principal Investigator: John Vanchiere, MD, PhD
Phone: 318-675-7877
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St. Louis, Missouri 63110
Principal Investigator: Gregory Storch, M.D.
Phone: 314-454-6079
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Tampa, Florida 33606
Principal Investigator: Jorge Lujan-Zilbermann, MD
Phone: 813-259-8800
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Principal Investigator: Roberta L DeBiasi, MD
Phone: 202-476-5051
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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