Pharmacogenetics of Antiretroviral Drugs

NCT ID: NCT00435656

Last Updated: 2011-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Brief Summary

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In this research project, we will study the genetic determinants that influence the pharmacokinetics of antiretroviral drugs used in the treatment of diseases caused by the HIV.

Detailed Description

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The development of new active substances is a continuous source of progress in pharmacotherapy. However, the search for an optimal use of existing molecules constitutes another possible way of progress. In the particular field of anti-infectious therapy, an optimization of treatments could minimize the emergence of resistance phenomena that require the continuous development of new active molecules.

Pharmacogenetics is the scientific discipline seeking to improve the response to drug therapies (better clinical efficiency and reduction of side effects) by taking into consideration the genetic characteristics of the patient. Drugs with a narrow therapeutic index constitute a main target of this emerging field. The combination of therapeutic drug monitoring and pharmacogenetics already allows to optimize the use of some drugs among which oral anticoagulants, immunosuppressants, antiepileptics, antidepressors, antibiotics or antivirals….

In this research project, we will study the genetic determinants that influence the pharmacokinetics of antiretroviral drugs used in the treatment of diseases caused by the HIV. We will put a particular emphasis on viral protease inhibitors (atazanavir, saquinavir, lopinavir, ritonavir)and non-nucleosides reverse transcriptase inhibitors (nevirapine and efavirenz). For those drugs, the clinician often faces a double therapeutic risk, either of insufficient dosing (clinical inefficacy and emergence of resistance) or of excessive dosing (toxicity). The optimization of drug dosing is especially crucial because some of these drugs often represent the last choice in multi-resistant patients.

Conditions

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HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* HIV infected patients

Exclusion Criteria

* pregnant women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université Catholique de Louvain

OTHER

Sponsor Role collaborator

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Laure Elens

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vincent Haufroid, PharmD PhD

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

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Cliniques universitaires saint Luc

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2006/11OCT/AC/189

Identifier Type: -

Identifier Source: org_study_id

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