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Gardel clinical trial with once daily variation
Mar 2, 2014

Dear Dr. Young, The GARDEL clinical trial (NTC reference NCT01237444) concluded that viral suppression can be achieved with a regimen of 2 active drugs (Lamivudine plus Kaletra). The trial was done with twice-daily dosage of each of these drugs. Since both drugs can also be administered once daily, would taking them that way achieve the same result? Thank you. With kind regards, Santiago.

Response from Dr. Young

Hello Santiago and thanks for posting your interesting question.

The Gardel study showed that Kaletra + 3TC (dosed twice daily) was very similar to Kaletra + the usual 2nukes for first line treatment.

I was lucky to ask your question to Dr. Pedro Cahn, my colleague, friend, and the lead investigator for GARDEL study. He said that GARDEL used twice daily Kaletra because this dosing tends to be much better tolerated than once-daily Kaletra treatment; and in some countries, once-daily Kaletra is not approved for use.

We speculated that the twice daily has slightly better pharmacokinetic properties too. Thinking outside of the study, it would be reasonable to speculate that once someone was stable, undetectable and tolerating the twice daily regimen that a switch/simplification to once-daily could be considered.

One has to wonder if similar results could have been achieved with other better tolerated, once-daily boosted PIs. But that wasn't the study.

Hope that helps, BY



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