ABT-378/r Compassionate Use Program
Abbott has announced an early access program for ABT-378/r. Due to concerns about drug availability, the program started off small -- limited to the neediest patients with less than 50 CD4 cells. More recently, the maximum CD4 count has risen to 200. At this point, enrollment is open for males and non-pregnant females (13 years or older) who have a CD4 count <200 cells, viral loads over 10,000 copies/ml, and either a documented failure on HAART or intolerance to two PIs. These criteria will be even less restrictive when more of the drug is available, probably in January, 2000, and Abbott expects to have enough drug for a couple thousand patients.
Since entry criteria require that patients are currently failing their drug regimen and because it is recommended that at least two new drugs are added to a failing regimen, it might be advisable for some people to wait -- if feasible -- until other experimental drugs (such as T-20 or tenofovir) are also available to them.
For further information, patients and doctors can call (888) 711-7193 in the US and Canada or 00-800-49-68-59-90 outside North America.
Back to the GMHC Treatment Issues September/October 1999 contents page.
This article was provided by Gay Men's Health Crisis. It is a part of the publication GMHC Treatment Issues. Visit GMHC's website to find out more about their activities, publications and services.