The Adv Halt Trial



Status:Recruiting
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:November 2010
Contact:John Edwards, MD
Email:Chimerix350@ctifacts.com
Phone:855-825-7401

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A Randomized, Placebo-Controlled Multi-Site Phase 2 Study Evaluation the Safety and Efficacy of Preemptive Treatment With CMX001 for the Prevention of Adenovirus Disease Following Hematopoietic Stem Cell Transplantation in Adults and Children


The primary objective of this study is to evaluate the safety and efficacy of preemptive
treatment with CMX001 versus placebo for the prevention of AdV disease in recipients of HSCT
with asymptomatic AdV viremia.


Inclusion Criteria:

1. Males and females ≥ 3 months and ≤ 75 years of age.

2. Subjects have received an allogeneic HSCT.

3. Positive serum AdV PCR (> 100 copies/mL) as measured by the central laboratory.

4. Subject or guardian(s) are willing to comply with the protocol.

5. Subject or guardian(s) are willing and able to understand the informed
consent/assent.

6. Females of child-bearing potential must have a negative pregnancy test (serum
beta-hCG) and sexually active females must use a reliable and medically approved
method of contraception throughout the study. Sexually active males of procreation
potential must be able and willing to use a reliable and medically approved
contraceptive method throughout the study. At least one barrier method of
contraception must be used, in subjects of procreation potential.

Exclusion Criteria:

1. Subject has possible, probable, or definitive AdV disease. See Appendix 2Error!
Reference source not found. for a definition and criteria outlining possible,
probable or definitive AdV disease.

2. Suspected gut graft versus host disease (GVHD) that is not biopsy-proven (subjects
with a biopsy performed may be included in the study).

3. Subject has an eGFR ≤ 30 mL/minute and is not currently on dialysis.

4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 10 times the
ULN, conjugated bilirubin > 5 times the upper limit of normal (ULN).

5. Subject has mucositis preventing ingestion of oral medication.

6. Subject is Human Immunodeficiency Virus (HIV) antibody positive, based upon available
medical records.

7. Subject has ocular hypotony, uveitis, or retinitis or any other intraocular pathology
that would predispose the subject to one of these conditions.

8. Subject has participated in any other investigational drug study or was exposed to an
investigational drug within 14 days of enrollment.

9. Is pregnant or breast-feeding or intending to conceive during the course of the
study, including the follow-up period after drug discontinuation.

10. Known immunologic hypersensitivity to CDV or CMX001 drug or any of its excipients.

11. History of illicit drug use or alcohol abuse within the previous 6 months.

12. Any medical condition that, in the opinion of the Investigator, might interfere with
the subject's participation in the study, poses an added risk for the subject, or
confounds the assessment of the subject (e.g. severe cardiovascular, central nervous
system (CNS) or pulmonary disease).

13. Subject has received CMX001, CDV, ribavirin, or leflunomide within the previous 14
days.
We found this trial at
30
sites
30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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1600 7th Avenue
Birmingham, Alabama 35233
(205) 638-9100
Children's Hospital of Alabama Children
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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500 Parnassus Ave
San Francisco, California 94110
(415) 476-9000
University of California, San Francisco UCSF's clinical enterprise is recognized nationally for its leading health...
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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40 Sunshine Cottage Road
Valhalla, New York 10595
(914) 594-4000
New York Medical College The College was founded in 1860 by a group of New...
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Aurora, Colorado 80045
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Boston, Massachusetts 02115
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Dallas, Texas 75390
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1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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Los Angeles, California 90033
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Memphis, Tennessee 38105
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Minneapolis, Minnesota 55414
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New York City, New York 10021
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Orange, California 92868
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Pheonix, Arizona 85016
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Salt Lake City, Utah 84113
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St. Louis, Missouri 63110
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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