- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002165
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.)
Study Overview
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
San Diego, California, United States, 92121
- Agouron Pharmaceuticals Inc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Protease Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Nelfinavir
Other Study ID Numbers
- 259B
- Study 515
- AG1343 - 515
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on Nelfinavir mesylate
-
Agouron PharmaceuticalsCompletedHIV Infections | Cytomegalovirus RetinitisUnited States
-
Agouron PharmaceuticalsCompletedHIV Infections | Mycobacterium Avium-Intracellulare InfectionUnited States
-
Agouron PharmaceuticalsCompleted
-
Agouron PharmaceuticalsCompletedHIV Infections | Sarcoma, KaposiUnited States
-
Agouron PharmaceuticalsCompleted
-
National Cancer Institute (NCI)Completed
-
Bristol-Myers SquibbTerminatedHIV InfectionsUnited States, Mexico, Canada, Puerto Rico, Thailand
-
Pharmacia and UpjohnCompletedHIV InfectionsUnited States
-
Merck Sharp & Dohme LLCCompletedHIV InfectionsUnited States
-
Swiss Group for Clinical Cancer ResearchCompletedLymphoma | Leukemia | Multiple Myeloma and Plasma Cell Neoplasm | Mature T-cell and Nk-cell NeoplasmsSwitzerland