An Open Label Pharmacokinetic, Safety And Efficacy Study Of Maraviroc In Combination With Background Therapy For The Treatment Of HIV-1 Infected, CCR5 -Tropic Children



Status:Active, not recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:2 - 18
Updated:4/4/2019
Start Date:April 22, 2009
End Date:July 29, 2019

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AN OPEN-LABEL, MULTICENTER, MULTIPLE-DOSE PHARMACOKINETIC, SAFETY AND EFFICACY TRIAL OF MARAVIROC IN COMBINATION WITH OPTIMIZED BACKGROUND THERAPY FOR THE TREATMENT OF ANTIRETROVIRAL-EXPERIENCED CCR5-TROPIC HIV-1 INFECTED CHILDREN 2 - <18 YEARS OF AGE

The primary purpose of this study is to determine the pharmacokinetic properties (what the
body does to maraviroc) and to determine a suitable dosing schedule of maraviroc in HIV-1
infected children and adolescents. This study will also determine whether maraviroc is safe
to use in children and adolescents.


Inclusion Criteria:

- Subjects who are 2-18 years of age, treatment experienced for 6 months or longer with
at least 2 ARV drug classes, with HIV-1 RNA ≥1,000 copies/mL

Exclusion Criteria:

- X4- or dual/mixed-tropic virus detected by the Trofile™ viral tropism assay

- Concomitant therapy with other investigational agents (other than experimental ARV
agents available through pre-approval access programs)

- Known ≥Grade 3 of any of the following laboratory tests at Screening or within 30 days
prior to Baseline Visit: Neutrophil count, hemoglobin, platelets, AST, ALT, and
creatinine, lipase;

- Total bilirubin ≥Grade 3, unless ALL of the following are true: Current regimen
includes atazanavir; ALT/AST < 2.5 X ULN; No symptoms other than jaundice or icterus.

- Other laboratory values ≥Grade 3, must be reviewed by Pfizer.
We found this trial at
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sites
4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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Miami, FL
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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Orange, CA
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1600 Rockland Road
Wilmington, Delaware 19803
(302) 651-4200
Alfred I. duPont Hospital for Children Nemours began more than 70 years ago with the...
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1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
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Atlanta, Georgia 30322
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Cincinnati, OH
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1935 Medical District Dr
Dallas, Texas 75235
(214) 456-7000
Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
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Houston, Texas 77030
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Jackson, Mississippi 39213
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Jackson, Mississippi 39216
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Jackson, Mississippi 39216
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655 West 8th Street
Jacksonville, Florida 32209
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Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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417 North 11th Street
Richmond, Virginia 23298
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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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