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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

Brief 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.

Detailed Summary: 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.
Sponsor: University of Alabama at Birmingham

Current Primary Outcome:

  • Evaluate the safety and tolerability of CMX001 oral suspension in infants being treated for neonatal HSV CNS disease. [ Time Frame: Baseline through day 21 ]
  • Determine the plasma pharmacokinetics of the CMX001 and cidofovir following administration of CMX001 oral suspension in infants being treated for neonatal HSV CNS disease. [ Time Frame: Baseline through day 21 ]


Original Primary Outcome: Plasma pharmacokinetic parameters for CDV and CMX001, including AUC24, maximum serum concentration (Cmax), half-life (T1/2), CL/F, and time to maximum concentration (Tmax) [ Time Frame: From baseline through visit day 21 ]

Current Secondary Outcome:

  • Explore a plasma drug concentration-response relationship between CMX001 exposure and quantity of HSV DNA in cerebrospinal fluid (CSF) at Day 4 of antiviral therapy [ Time Frame: Baseline through day 21 ]
  • Explore a plasma drug concentration-response relationship between cidofovir exposure and quantity of HSV DNA in cerebrospinal fluid (CSF) at Day 4 of antiviral therapy [ Time Frame: Baseline through day 56 (end of study) ]


Original Secondary Outcome:

  • Clearance of HSV DNA from CSF by Day 4 of antiviral treatment of neonatal HSV disease [ Time Frame: baseline through visit day 21 ]
  • The incidence of SAEs and AEs considered to be related to study treatment [ Time Frame: Baseline through visit day 56 (end of study) ]
  • The incidence of grade 3-4 AEs and SAEs, with or without relationship to study treatment [ Time Frame: Baseline through visit day 56 (end of study) ]
  • Intracellular pharmacokinetic parameters for the active diphosphate moiety of CDV in peripheral blood mononuclear cells (PBMCs) [ Time Frame: baseline through visit day 21 ]
  • Correlation of CDV plasma and intracellular concentrations with qualitative and quantitative HSV detection in cerebrospinal fluid and blood by PCR [ Time Frame: baseline through visit day 21 ]


Information By: University of Alabama at Birmingham

Dates:
Date Received: May 30, 2012
Date Started: January 2016
Date Completion: June 2017
Last Updated: June 6, 2016
Last Verified: June 2016