Abbott expands early-access program for ABT-378/r (Kaletra)

Abbott Laboratories have announced that more HIV-positive patients will now have access to its investigational protease inhibitor Kaletra (lopinavir/ritonavir) via the company’s Early Access Program.

The company, based in Abbott Park, Ill, relaxed the criteria that HIV-positive patients must meet to receive Kaletra, formerly ABT-378/r. The drug will now be available to any HIV-positive patient who needs it to “construct a viable regimen, without CD4 cell count or viral load restrictions,” Abbott said in a news release.

Because of a limited supply of the drug, which is currently in phase III trials, Abbott’s Early Access Program was previously open only to patients with HIV who met select entry criteria.

Developed in cooperation with key regulatory agencies and HIV advocacy groups, Abbott’s Kaletra Early Access Program operates in 21 countries worldwide and has enrolled 6100 patients with advanced HIV.


Some UK physicians are still unaware that ABT-378 is available on named patient and open access studies. Interested physicians should contact Abbott in the UK on: 01628 644 370.

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