Viracept Expanded Access Program

Sponsor

Agouron Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00002165

Collaborator

(none)

Location

Study Details

Study Description

Brief 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.)

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Nelfinavir mesylate	N/A

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

Viracept Expanded Access Program

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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