Viracept Expanded Access Program

Agouron Pharmaceuticals

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Nelfinavir mesylate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002165

259B

Study 515

AG1343 - 515

Details and patient eligibility

About

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.)

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.