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 |
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.
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
20
sites
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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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
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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University of South Florida The University of South Florida is a high-impact, global research university...
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Alfred I. duPont Hospital for Children Nemours began more than 70 years ago with the...
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Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
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Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
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655 West 8th Street
Jacksonville, Florida 32209
Jacksonville, Florida 32209
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Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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111 Michigan Ave NW
Washington, District of Columbia
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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