Viracept Expanded Access Program - Full Text View

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
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002165
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:

Virus Diseases

Sexually Transmitted Diseases, Viral

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Nelfinavir

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents

RNA Virus Infections

HIV Protease Inhibitors

Slow Virus Diseases

Anti-HIV Agents

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Protease Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

ClinicalTrials.gov processed this record on December 03, 2008

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