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Expanded Access

September 1999

These new drugs are currently available free of charge while awaiting FDA approval.

Protease Inhibitors

ABT-378

888-711-7193

Abbott Laboratories, the developers of a new protease inhibitor ABT-378, (see New Antivirals in Development), will start an early access program for the drug in September. This will initially be a very small program, allowing only 700 people worldwide, early access to the drug (about one-half in the US). This program will expand rapidly beginning in January, 2000. To qualify for the program, people must have all of the following:

  • Less than 50 CD4+ cells (within the past three months) and greater than 10,000 copies HIV RNA or an active opportunistic infection within the past three months
  • Intolerance to and/or failure (viral load increases) to at least two previously used protease inhibitors
  • Unable to construct a viable combination without ABT-378

To register patients in the program, physicians should call (888) 711-7193. In the US, the drug will be accessed through about 35 clinics, though people need not be receiving their medical care through those clinics to qualify for the program. For locations of these clinics, please call Project Inform's National HIV/AIDS Treatment Hotline.

NtARTIs (Nucleotide Analog Reverse Transcriptase Inhibitors)

Adefovir

800-445-3235

For anyone failing current therapy and requiring an additional new drug for treatment strategy.

Tenofovir (PMPA)

Phone number not available yet. Call Project Inform's Hotline for an update.

Entry criteria same as for ABT-378. This will be a very small program limited to 300 people in the US. The program will begin in October, 1999, but unlike the ABT-378 program, it will not expand until after June, 2000.


Back to the Project Inform Perspective September 1999 contents page.




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