Viracept Expanded Access Program

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.)

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Agouron Pharmaceuticals
• Treatments: Nelfinavir

Criteria

Inclusion Criteria

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.)

Exclusion Criteria

Prior Medication:

Excluded:

Prior therapy with Viracept.

Required:

• Indinavir.

• Saquinavir.

• Ritonavir.