Status:
COMPLETED
Individualized Antiretroviral Therapy
Lead Sponsor:
Hospital Italiano de Buenos Aires
Conditions:
Pharmacogenetics
HIV
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The efficacy and safety of antiretroviral therapy and the damage caused by chronic inflammation in the presence of the virus has recently lead to the consideration of initiating antiretroviral therapy...
Detailed Description
I) General Objectives To establish the overall impact of pharmacogenomic (PG) analysis and therapeutic drug monitoring (TDM) for the selection of the proper dose of efavirenz or atazanavir in patients...
Eligibility Criteria
Inclusion
- Adult patients with diagnosis of chronic HIV infection confirmed by Western blot and / or HIV viral load
- Patients in whom (according to the judgment of the treating physician) antiretroviral therapy should be initiated and this treatment will be a regimen based on Efavirenz or Atazanavir.
- Availability of a baseline genotyping test confirming the absence of primary resistance for the selected drugs.
- Signature of the informed Consent Form
Exclusion
- Patients who remain untreated or those treated with a regimen that does not include efavirenz or atazanavir
- Lack of understanding of the study characteristics or rejection to have samples taken for the pharmacological studies.
- Patients who are not expected to continue their follow-up at the research center for at least one year
- Patients with coinfections or comorbidities that prevent a dose adjustment of efavirenz or atazanavir based on pharmacological parameters.
Key Trial Info
Start Date :
October 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT03385473
Start Date
October 5 2017
End Date
December 31 2019
Last Update
September 9 2025
Active Locations (1)
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1
Hospital Italiano de Buenos Aires - Infectious Diseases Section
Buenos Aires, Buenos Aires F.D., Argentina, 1181