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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
  Purpose

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.


Condition Phase
HIV Infections
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional

Resource links provided by NLM:


Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Estimated Enrollment: 200
Study Start Date: September 2007
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

HIV infected patients

Criteria

Inclusion Criteria:

  • HIV infected patients

Exclusion Criteria:

  • pregnant women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435656

Locations
Belgium
Cliniques universitaires saint Luc
Brussels, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Université Catholique de Louvain
Investigators
Principal Investigator: Vincent Haufroid, PharmD PhD Cliniques universitaires Saint-Luc
  More Information

No publications provided

Responsible Party: Laure Elens, PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT00435656     History of Changes
Other Study ID Numbers: 2006/11OCT/AC/189
Study First Received: February 14, 2007
Last Updated: August 24, 2011
Health Authority: Belgium: Institutional Review Board

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Human immunodeficiency virus

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014