the trial assessed the pharmacokinetics and long term plasma exposure of the following antiretrovirals: atazanavir when combined to ritonavir and the tenofovir/emtricitabine fixed-dose combination. All drugs will be delivered in MEMS electronic device to monitor dosing history.
The trial is a phase II, open label, non-randomized, prospective multicenter trial to assess the pharmacokinetics and long term plasma exposure of the following antiretrovirals: atazanavir when combined to ritonavir and the tenofovir/emtricitabine fixed-dose combination. All drugs will be delivered in MEMS electronic device to monitor dosing history.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Hopital du Kremlin Bicêtre Service de médecine interne
Kremlin Bicëtre, France
Hopital Bichat CIC
Paris, France
pharmacokinetic parameters of atazanavir (ATV) when combined with ritonavir (RTV) and tenofovir/emtricitabine
Time frame: week 4
pharmacokinetics of emtricitabine and tenofovir; intraindividual variability in ARVs concentrations; adherence measured with MEMS records and validated ANRS observance autoquestionnaire; relationships between virological response or side event occurrence
Time frame: Week 24
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