HIV Clinical Trial
Official title:
Open, Parallel and Randomised Pilot Clinical Trial to Evaluate the Utility of the Therapeutic Monitoring of Plasma Levels of Efavirenz in Hiv-Infected Patients Initiating an Antiretroviral Treatment Regimen With Sustiva
This is a study on the utility of the modification of doses of efavirenz guided by its plasma concentration (therapeutic drug monitoring) in HIV-infected patients initiating treatment with Sustiva.
Currently, efavirenz is dosed systematically, without taking into account the individual
characteristics of each individual patient. However, plasma concentration of efavirenz may
widely vary between different subjects that receive the same dose of the drug
(interindividual variability).
Therapeutic drug monitoring (TDM) signifies individualised pharmacological dosing, based on
the plasma levels that each patient presents. This strategy has been broadly used in the
field of the treatment of other medical conditions and is acquiring growing interest in the
field of antiretroviral treatment. Thus, the use of TDM for the treatment of naïve patients
with nelfinavir or with indinavir has translated into an increase in the proportion of
individuals with suppressed viral load and also into a reduction in HAART-induced adverse
events . However, data on the utility of the therapeutic monitoring of the levels of
efavirenz in HIV-infected patients are very scant.
On the basis of the above, it might be thought that the modification of the doses of
efavirenz, guided by its plasma concentration, in patients receiving this drug and whose
plasma levels of efavirenz are outside the therapeutic range, might improve the tolerability
of the treatment without compromising virological efficacy.
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