Individualized Antiretroviral Therapy

Launched by HOSPITAL ITALIANO DE BUENOS AIRES · Dec 20, 2017

Keywords

ClinConnect Summary

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 with an HIV infection who have not received prior antiretroviral treatment.

II) Specific objectives and working hypothesis Establish the usefulness of PG and TDM in determining the efficacy, safety and cost/effectiveness of a first-line antiretroviral therapy containing either efavirenz or atazanavir in patients with HIV infection who have not received prior antiretroviral therapy.

II b. Wor...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.