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 unconfirmed · Phase 2

Conditions studied: Human Immunodeficiency Virus

In brief

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.

Key facts

Study ID

NCT00791700

Run by

ViiV Healthcare

People needed

103

Starts

2009-04-22

Expected to finish

2023-06-30

Last updated by the study team

2020-04-28

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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 — Padova, Italy
• Farmacia Interna — Padova, 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

Full record on ClinicalTrials.gov

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