Viracept Expanded Access Program

Completed · Not applicable

Conditions studied: HIV Infections

In brief

To make nelfinavir mesylate (Viracept) available for treatment of HIV positive patients who are unable to take the three commercially available protease inhibitors (because of failure, intolerance, or contraindication) and who have a CD4 cell count of \<= 50. To obtain additional information on the safety profile of nelfinavir mesylate (Viracept). (PER AMENDMENT 1/8/97: People now qualify for the Viracept Program if they are unable to take indinavir and/or ritonavir due to intolerance, contraindication or prior failure.)

Key facts

Study ID

NCT00002165

Run by

Agouron Pharmaceuticals

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have:
• HIV infection.
• CD4 T cell count <= 100 cells/mm3.
• Failed, been intolerant of or had a contraindication to all three commercially available protease inhibitors (saquinavir, indinavir and ritonavir).
• (PER AMENDMENT 1/8/97:
• People now qualify for the Viracept Program if they are unable to take indinavir and/or ritonavir due to intolerance, contraindication or prior failure.)

You may not qualify if…

• Prior Medication:
• Excluded:
• Prior therapy with Viracept.
• Required:
• Indinavir.
• Saquinavir.
• Ritonavir.

Where it is running

• Agouron Pharmaceuticals Inc — San Diego, California, United States

Full record on ClinicalTrials.gov

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