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
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 and adolescents. This study will also determine whether maraviroc is safe to use in children and adolescents.
Study Design
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Human Immunodeficiency Virus (HIV)
Intervention
Maraviroc
Location
Pfizer Investigational Site
Phoenix
Arizona
United States
85016
Status
Recruiting
Source
ViiV Healthcare
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00791700
- Information obtained from ClinicalTrials.gov on May 16, 2013
Medical and Biotech [MESH] Definitions
Vif Gene Products, Human Immunodeficiency Virus
Proteins encoded by the VIF GENES of the HUMAN IMMUNODEFICIENCY VIRUS.
Rev Gene Products, Human Immunodeficiency Virus
Proteins encoded by the REV GENES of the HUMAN IMMUNODEFICIENCY VIRUS.
Vpr Gene Products, Human Immunodeficiency Virus
Proteins encoded by the VPR GENES of the HUMAN IMMUNODEFICIENCY VIRUS.
Nef Gene Products, Human Immunodeficiency Virus
Proteins encoded by the NEF GENES of the HUMAN IMMUNODEFICIENCY VIRUS.
Tat Gene Products, Human Immunodeficiency Virus
Proteins encoded by the TAT GENES of the HUMAN IMMUNODEFICIENCY VIRUS.
Clinical Trials
To investigate the relationship between the pharmacokinetics and pharmacodynamics of UK-427,857 and its antiviral effects in patients with human immunodeficiency virus (HIV).
The purpose of this study is to assess whether a dosing adjustment is needed in patients with renal impairment.
The objective of this study is to provide Maraviroc on a compassionate use basis to antiretroviral treatment experienced patients infected with CCR5-tropic HIV-1 with urgent unmet medical...
The new protocol will allow the patients enrolled on A4001050 to have continuous access of Maraviroc and the treatment will not be interrupted until the drug is commercially available in I...
To investigate the effects of food and dose regimen on the antiviral effects of Maraviroc (UK-427,857) in patients with human immunodeficiency virus (HIV)
PubMed Articles
Clinical Utility of Maraviroc.
Maraviroc belongs to the family of chemokine (C-C motif) receptor 5 (CCR5) antagonists that prevent the entry of human immunodeficiency virus (HIV) into host CD4+ T cells by blocking the CCR5 co-recep...
Background:Most human immunodeficiency virus positive patients now have a longer life expectancy, with the advent of highly active antiretroviral therapy. However, they are now at increased risk of de...
Hepatic safety and tolerability in the maraviroc clinical development program.
Maraviroc is the first CCR5 antagonist to be approved for the treatment of HIV-1 infection. It is generally well tolerated, with a similar side-effect profile to placebo in controlled studies. Many ag...
Maraviroc binds to the pocket of extracellular loops of the cell surface CCR5 and prevents R5 HIV-1 from using CCR5 as a coreceptor for entry into CD4-positive cells. To evaluate the contribution of t...
Human immunodeficiency virus (HIV) entry into susceptible cells involves the interaction between viral envelope glycoproteins with CD4 and a chemokine receptor (coreceptor), namely CCR5 and CXCR4. Thi...
