Virus-HIV Clinical Trial
Official title:
QD Isentress as Switch Strategy in Virologically Suppressed HIV-1 Infected-Patient
Raltegravir (RAL) is a very effective antiretroviral drug with a favorable long term
tolerability. RAL offers many advantages such as lack of drug-drug interactions, a good
safety profile particularly on lipids, inflammation and bone parameters. Ral can be an very
interesting for patient with comorbidities and comedications, intolerance or toxicities with
their current ARV treatment. However its current formulation of one tablet of 400mg twice a
day coul not suit many patients.
A new once-a-day formulation of RAL has been developed, with two tablets of 600 mg QD.
Pharmacokinetic study in healthy volunteers has shown that this dosing provides increased RAL
exposure compared to the standard formulation of 400 mg given twice a day.
The objective of this study is to evaluate the maintain of virologic suppression with
raltegravir 600mg 2 tablets qd as part of a triple antiretroviral regimen in virologically
controlled patients.
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