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Clinical Trials/NCT00002165
NCT00002165CompletedNot Applicable

Viracept Expanded Access Program

Agouron Pharmaceuticals1 site in 1 countryStarted: August 31, 2001Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Locations
1
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.)

Study Design

Study Type
Interventional
Primary Purpose
Treatment

Eligibility Criteria

Ages
13 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients must have:
  • •HIV infection.
  • •CD4 T cell count <= 100 cells/mm
  • •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:
  • •Prior therapy with Viracept.
  • •Indinavir.
  • •Saquinavir.
  • •Ritonavir.

Investigators

Sponsor
Agouron Pharmaceuticals
Sponsor Class
Industry

Study Sites (1)

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