Viracept Expanded Access Program - Full Text View

Sponsored by:	Agouron Pharmaceuticals
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002165

Purpose

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	Intervention
HIV Infections	Drug: Nelfinavir mesylate

MedlinePlus related topics: AIDS

Drug Information available for: Nelfinavir Nelfinavir Mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Safety Study
Official Title:	Viracept Expanded Access Program

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002165

Locations

United States, California
Agouron Pharmaceuticals Inc
San Diego, California, United States, 92121

Sponsors and Collaborators

Agouron Pharmaceuticals

More Information

Publications:

[No authors listed] New protease inhibitor available through expanded access. Posit Aware. 1996 Nov-Dec;7(6):7. No abstract available.

Study ID Numbers:	259B, Study 515, AG1343 - 515
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002165 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Acquired Immunodeficiency Syndrome
HIV Protease Inhibitors
CD4 Lymphocyte Count
Nelfinavir
Anti-HIV Agents

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
HIV Protease Inhibitors
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Antiviral Agents
Immunologic Deficiency Syndromes
Protease Inhibitors

Virus Diseases
Anti-Retroviral Agents
HIV Infections
Sexually Transmitted Diseases
Nelfinavir
Retroviridae Infections

Additional relevant MeSH terms:

Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection
Antiviral Agents

Pharmacologic Actions
Immunologic Deficiency Syndromes
Protease Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Nelfinavir
Retroviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009