A Safety and Dose-Determining Study of CMX001 In Infants With Neonatal Herpes Simplex Virus (HSV) Infection Involving the Central Nervous System (CNS Disease)
NCT ID: NCT01610765
Last Updated: 2016-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2016-01-31
2017-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System
NCT00006132
Acyclovir for Herpes Infections Involving the Central Nervous System in Neonates
NCT00031460
Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Limited to Skin, Eyes, and Mouth
NCT00006135
Pharmacokinetics, Acceptability and Safety of Famciclovir in Infants (1 Month to Less Than 12 Months) With Herpes Simplex Infection
NCT00448227
Acyclovir Herpes Simplex Virus (HSV) Skin, Eye, and Mouth
NCT00031447
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Novel Antiviral Drug
Subjects will be randomized to receive one of 3 oral doses of a Novel Antiviral Drug: 0.50 mg/kg/dose, 1.0 mg/kg/dose or 2.0 mg/kg/dose twice a week for up to 3 weeks during the time in which the 21 day administration of parenteral acyclovir is being administered
Novel Antiviral Drug
4 oral doses of a Novel Antiviral Drug: 0.25 mg/kg/dose, 0.50 mg/kg/dose, 1.0 mg/kg/dose or 2.0 mg/kg/dose twice a week for 3 weeks during the time in which the 21 day administration of parenteral acyclovir is being administered. Subjects will be assigned a the higher dose of study drug after the DSMB and sponsor determine that reported adverse events and the PK data show that it is safe to increase dosing to the next higher level.
Placebo
Subjects will be randomized to receive one of 3 oral doses of placebo matched in volume to active drug: 0.50 mg/kg/dose, 1.0 mg/kg/dose or 2.0 mg/kg/dose twice a week for up to 3 weeks during the time in which the 21 day administration of parenteral acyclovir is being administered
Placebo
4 oral doses of placebo matching the a Novel Antiviral Drug assigned dose: 0.25 mg/kg/dose, 0.50 mg/kg/dose, 1.0 mg/kg/dose or 2.0 mg/kg/dose twice a week for 3 weeks during the time in which the 21 day administration of parenteral acyclovir is being administered. Subjects will be assigned a the higher dose of study drug after the DSMB and sponsor determine that reported adverse events and the PK data show that it is safe to increase dosing to the next higher level.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Novel Antiviral Drug
4 oral doses of a Novel Antiviral Drug: 0.25 mg/kg/dose, 0.50 mg/kg/dose, 1.0 mg/kg/dose or 2.0 mg/kg/dose twice a week for 3 weeks during the time in which the 21 day administration of parenteral acyclovir is being administered. Subjects will be assigned a the higher dose of study drug after the DSMB and sponsor determine that reported adverse events and the PK data show that it is safe to increase dosing to the next higher level.
Placebo
4 oral doses of placebo matching the a Novel Antiviral Drug assigned dose: 0.25 mg/kg/dose, 0.50 mg/kg/dose, 1.0 mg/kg/dose or 2.0 mg/kg/dose twice a week for 3 weeks during the time in which the 21 day administration of parenteral acyclovir is being administered. Subjects will be assigned a the higher dose of study drug after the DSMB and sponsor determine that reported adverse events and the PK data show that it is safe to increase dosing to the next higher level.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
1 Day
98 Days
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Alabama at Birmingham
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
David Kimberlin, MD
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David W Kimberlin, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Richard Whitley, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DMID 11-0068
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.