Pharmacogenetics of Antiretroviral Drugs

This study has been completed.
Sponsor:
Collaborator:
Université Catholique de Louvain
Information provided by (Responsible Party):
Laure Elens, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT00435656
First received: February 14, 2007
Last updated: August 24, 2011
Last verified: August 2011

February 14, 2007
August 24, 2011
September 2007
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00435656 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pharmacogenetics of Antiretroviral Drugs
Not Provided

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Probability Sample

HIV infected patients

HIV Infections
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
Not Provided
Not Provided

Inclusion Criteria:

  • HIV infected patients

Exclusion Criteria:

  • pregnant women
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00435656
2006/11OCT/AC/189
Not Provided
Laure Elens, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Université Catholique de Louvain
Principal Investigator: Vincent Haufroid, PharmD PhD Cliniques universitaires Saint-Luc
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP