Status:
UNKNOWN
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
Lead Sponsor:
ViiV Healthcare
Collaborating Sponsors:
Pfizer
Conditions:
Human Immunodeficiency Virus
Eligibility:
All Genders
2-18 years
Phase:
PHASE2
Brief Summary
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 22 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00791700
Start Date
April 22 2009
End Date
June 30 2023
Last Update
April 28 2020
Active Locations (41)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
2
Children's Hospital of Orange County
Orange, California, United States, 92868
3
Alfred I. DuPont Hospital for Children
Wilmington, Delaware, United States, 19803
4
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010