Press room ... 2002 archive

Atazanavir Expanded Access

May 15, 2002

San Francisco—Bristol-Myers Squibb has started enrolling patients in an early access program to provide the experimental protease inhibitor, atazanavir, to eligible patients infected with HIV who are in need of an investigational antiretroviral agent.

An early access program (EAP) provides medicines to patients in need prior to the medicine's approval. Atazanavir is in the late stage of clinical development as a product to treat HIV infection in combination with other antiretroviral agents.

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 (defined as a triglyceride level  > 750 mg/dL) 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 information)
• 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.