ClinicalTrials.gov
ClinicalTrials.gov Menu

Viracept Expanded Access Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00002165
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Viracept Expanded Access Program

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS





Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002165


Locations
United States, California
Agouron Pharmaceuticals Inc
San Diego, California, United States, 92121
Sponsors and Collaborators
Agouron Pharmaceuticals

Publications:
ClinicalTrials.gov Identifier: NCT00002165     History of Changes
Other Study ID Numbers: 259B
Study 515
AG1343 - 515
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: October 1996

Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome
HIV Protease Inhibitors
CD4 Lymphocyte Count
Nelfinavir
Anti-HIV Agents

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Nelfinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents