Expanded Access Program for Atazanavir

Bristol-Myers Squibb, the developer of a once-daily protease inhibitor, atazanavir, will start the first phase of a large expanded access program around May 15.

To qualify, people must meet the following criteria:

• be 16 or older
• a viral load over 5,000 while on HAART
• CD4+ count below 300
• Unable to construct a HAART regimen due to one or more of the following:
  • Previous treatment failure on HAART
  • Significantly high triglycerides or lipids
  • Other toxicity or intolerance, as defined by the protocol
  • Drug-drug interaction

  or

  • HAART-related high lipid levels that are unresponsive to lipid-lowering agents, regardless of viral load or CD4+ count

Some exclusions will also affect applicants, including:

• Current use of Kaletra, Crixivan or Sustiva (due to lack of drug interaction)
• Underlying heart disease or irregular heart beat

The requirements may change over the course of the program as new information becomes available. To register patients in the program, physicians should call 1-877-726-7327.

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This article was provided by Project Inform. It is a part of the publication What's New.