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
NCT ID: NCT00791700
Last Updated: 2020-04-28
Study Results
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View full resultsBasic Information
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UNKNOWN
PHASE2
103 participants
INTERVENTIONAL
2009-04-22
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PARALLEL
TREATMENT
NONE
Study Groups
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Maraviroc
Subjects will be stratified by age and formulation into one of the following cohorts:
Cohort 1: ≥2-\<6 years of age, maraviroc liquid formulation; Cohort 2: ≥6-\<12 years of age, maraviroc tablet formulation; Cohort 3: ≥6-\<12 years of age, maraviroc liquid formulation and Cohort 4: ≥12-\<18 years of age, maraviroc tablet formulation.
Maraviroc
Maraviroc will be administered twice daily either as a liquid or tablet formulation, depending on the age of the subject. The dosage administered will be dependent upon the subject's body surface area as well as the background therapy.
Interventions
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Maraviroc
Maraviroc will be administered twice daily either as a liquid or tablet formulation, depending on the age of the subject. The dosage administered will be dependent upon the subject's body surface area as well as the background therapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
2 Years
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
ViiV Healthcare
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Children's Hospital Los Angeles
Los Angeles, California, United States
Children's Hospital of Orange County
Orange, California, United States
Alfred I. DuPont Hospital for Children
Wilmington, Delaware, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Rainbow Center at University of Florida Health
Jacksonville, Florida, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Grady Health System, IDP
Atlanta, Georgia, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Pediatric Infectious Disease Clinic
Jackson, Mississippi, United States
Batson Specialty Clinic
Jackson, Mississippi, United States
University of Mississippi
Jackson, Mississippi, United States
Cincinnati Center for Clinical Research
Cincinnati, Ohio, United States
Children's Medical Center of Dallas
Dallas, Texas, United States
Children's Memorial Hermann Hospital
Houston, Texas, United States
UT Physician
Houston, Texas, United States
VCU Health System Clinical Research Services
Richmond, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Instituto de Infectologia Emilio Ribas
São Paulo, São Paulo, Brazil
Condomínio Edifício Parque Paulista
São Paulo, , Brazil
Clinica Pediatrica Azienda Ospedaliera di Padova
Padua, , Italy
Farmacia Interna
Padua, , Italy
IRCCS Ospedale Pediatrico Bambino Gesu
Roma, , Italy
Struttura Complessa a Direzione Universitaria Immunologia, Reumatologia e Malattie Infettive
Torino, , Italy
Hospital Infantil de Mexico Federico Gomez
Mexico City, Mexico City, Mexico
Centro Hospitalar Universitario do Algarve, EPE
Faro, , Portugal
Centro Hospitalar de Lisboa Central, EPE
Lisbon, , Portugal
Centro Hospitalar de Lisboa Norte, EPE
Lisbon, , Portugal
Hospital S. João, E.P.E
Porto, , Portugal
Hospital San Juan Research Unit
San Juan, PR, Puerto Rico
Iatros International
Bloemfontein, Free State, South Africa
Lakeview Hospital
Benoni, Gauteng, South Africa
Dr George Mukhari Hospital
Ga-Rankuwa, Gauteng, South Africa
Dr. Jan Fourie Medical Centre
Dundee, KwaZulu-Natal, South Africa
Embassy Drive Medical Center
Pretoria, , South Africa
Hospital Sant Joan de Deu
Esplugues de Llobregat, Barcelona, Spain, Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Department of Pediatric, Faculty of Medicine, Khon Kaen University
Muang, Changwat Khon Kaen, Thailand
Department of Pediatrics, Faculty of Medicine, Chiang Mai University
Muang, Chiang Mai, Thailand
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),
Bangkok, , Thailand
Department of Pediatrics, Faculty of Medicine, Siriraj Hospital
Bangkok, , Thailand
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2008-006873-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A4001031
Identifier Type: -
Identifier Source: org_study_id
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