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Pharmacogenomics of New Antiretrovirals

NCT02514369 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 179

Last updated 2024-01-16

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Université Catholique de Louvain

    collaborator OTHER

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    lead OTHER

Principal Investigators

  • Leila Belkhir, MD · Université Catholique de Louvain

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02514369 on ClinicalTrials.gov