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

Withdrawn before enrolling · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Herpes Simplex Virus

In brief

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.

Key facts

Study ID

NCT01610765

Run by

University of Alabama at Birmingham

People needed

0

Starts

2016-01-01

Expected to finish

2017-06-01

Last updated by the study team

2016-06-07

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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