Viracept Expanded Access Program

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002165
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: October 1996

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002165 on ClinicalTrials.gov Archive Site
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Viracept Expanded Access Program
Viracept Expanded Access Program

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.)

Not Provided
Interventional
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Endpoint Classification: Safety Study
Primary Purpose: Treatment
HIV Infections
Drug: Nelfinavir mesylate
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[No authors listed] New protease inhibitor available through expanded access. Posit Aware. 1996 Nov-Dec;7(6):7. No abstract available.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002165
259B, Study 515, AG1343 - 515
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Agouron Pharmaceuticals
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NIH AIDS Clinical Trials Information Service
October 1996

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP