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Pharmacogenomics of New Antiretrovirals

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ClinicalTrials.gov Identifier: NCT02514369
Recruitment Status : Unknown
Verified July 2015 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was:  Recruiting
First Posted : August 3, 2015
Last Update Posted : August 3, 2015
Sponsor:
Collaborator:
Université Catholique de Louvain
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study Description
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Brief Summary:
Some genetic polymorphisms are known to interfere with ARV metabolism and are therefore likely to explain some of the inter-individual variations (efficacy,toxicity,resistance) observed during ART. The most common form of human DNA variations consists of a change of a base in the nucleotide sequence of an individual at a given position, the single nucleotide polymorphism (SNP). Therefore,the purpose of this research will be the identification and characterization of the clinical impact of several SNPs in gene coding for transport proteins (e.g.ABCB1,ABCC1) and biotransformation enzymes (e.g.CYP3A4,CYP2B6) known to be involved in the pharmacokinetic pathway of selected ARV drugs for which the therapeutic response is difficult to predict. Aside,the influence of these SNPs on the response to treatment (CD4+cell,viral load) and on the toxicity will be evaluated. Plasma concentrations of ARV drugs correlate with therapeutic efficacy but also with the risk of toxicity and of virological failure, which is the basis of the therapeutic drug monitoring. However,given the intracellular location of HIV, analyzing intracellular drug concentrations is fundamental and the investigators will also focus of this new topic.

Condition or disease
HIV

Study Design
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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Pharmacogenetics of New Antiretroviral Drugs
Study Start Date : November 2012
Estimated Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Impact of pharmacogenomics on plasma concentration of new antiretroviral drugs [ Time Frame: up to 48 months ]
  2. Impact of pharmacogenomics on intracellular concentration of new antiretroviral drugs [ Time Frame: up to 48 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
HIV1-positive patients
Criteria

Inclusion Criteria:

  • HIV-1 positive treated with drug of interest

Exclusion Criteria:

  • <18 years old
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02514369


Contacts
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Contact: Leila Belkhir, MD 003227647087 leila.belkhir@uclouvain.be

Locations
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Belgium
Cliniques universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact: Leila Belkhir, MD    003227647087    leila.belkhir@uclouvain.be   
Sub-Investigator: Vincent Haufroid, Pharm PhD         
Sub-Investigator: Bernard Vandercam, MD         
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Université Catholique de Louvain
More Information
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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT02514369     History of Changes
Other Study ID Numbers: ARVLB01
First Posted: August 3, 2015    Key Record Dates
Last Update Posted: August 3, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
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Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents