For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. 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

  1. X4
  2. or dual/mixed-tropic virus detected by the Trofile™ viral tropism assay
  3. Concomitant therapy with other investigational agents (other than experimental ARV agents available through pre-approval access programs)
  4. 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;
  5. 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.
  6. Other laboratory values ≥Grade 3, must be reviewed by Pfizer.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
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Study’s details


Contition

Human Immunodeficiency Virus,Human Immunodeficiency Virus (HIV)

Age (in years)

2 - 18

Phase

Phase 2

Participants needed

103

Est. Completion Date

Jun 2023

Treatment type

Interventional


Sponsor

ViiV Healthcare

ClinicalTrials.gov identifier

NCT00791700

Study number

A4001031

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