CMX351: Experimental Drug Treatment for Adenovirus Infection

Brincidofovir for the Treatment of Serious Adenovirus Infection or Disease

Category:

Infectious Diseases

Diseases Treated:

Infectious Disease

Eligibility Overview:

  • 2 months old or older
  • Diagnosed with adenovirus (AdV) infection
  • Has symptoms related to AdV infection
  • Able to take and absorb oral medication
  • No previous treatment with brincidofovir (BCV)
  1. Brief Summary

    This study is an expanded access protocol to make brincidofovir (BCV) available to patients diagnosed with serious adenovirus (AdV) infection or disease who are not eligible for other BCV clinical trials.

    AdV infection in immunocompromised patients, such as allogeneic hematopoietic stem cell transplant patients, can be life-threatening. Findings from a previous Phase II study and an expanded access study suggest BCV may have some efficacy in preventing and treating AdV infection.

    This expanded access study consists of a screening evaluation to confirm eligibility and an initial 12-week treatment phase, during which patients will receive BCV two times a week. In some cases, treatment may be extended for up to 12 additional weeks for patients who have demonstrated clinical improvement but whose AdV infection has not resolved, or for patients at high risk of recurrence or relapse.

    Primary Objective

    • Provide patients with serious AdV infection or disease access to treatment with BCV

    Eligibility Criteria

    Inclusion criteria include:

    • 2 months old or older
    • Diagnosed with adenovirus (AdV) infection
    • Has symptoms related to AdV infection
    • Able to take and absorb oral medication
    • No previous treatment with brincidofovir (BCV)

    Exclusion Criteria include:

    • Pregnant or plans to become pregnant during the study or within 6 months after last BCV dose
    • Nursing an infant

    Study Sites

    St. Jude Children's Research Hospital
    Memphis, Tennessee

    Other collaborating sites in the U.S.

  2. About this study

    Adenoviruses belong to a group of viruses called double-stranded DNA viruses. In healthy people, these viruses can cause a mild infection. However, when the body’s immune system is not working properly, the infection can be much more serious.

    This clinical trial will test a new drug to treat AdV.  The drug is called brincidofovir, also known as BCV. In some studies, BCV has helped to control AdV infection. BCV is an experimental drug. It has not been approved by the U.S. Food and Drug Administration.

    Purpose of this clinical trial

    The main goal of this study is to give children with adenovirus infections access to BCV treatment when they do not qualify for other BCV clinical trials.

    Eligibility overview

    • 2 months old or older
    • Diagnosed with adenovirus (AdV) infection
    • Has symptoms related to AdV infection
    • Able to take and absorb oral medication
    • No previous treatment with brincidofovir (BCV)
  3. CMX351 Quick View
    Sponsors Chimerix
    ClinicalTrials.gov identifier NCT02596997
    Trial Start Date March 2016
    Estimated Enrollment 300 nationwide
    Study Type Expanded Access
    Conditions Adenovirus Infection
    Ages 2 months and older
    St. Jude Principal investigator Gabriela Marón Alfaro, MD
    Study Sites St. Jude Children’s Research Hospital and other collaborating sites in the U.S.
    For a consultation or to discuss CMX351 St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

Contact

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.