Back to resultsViracept Expanded Access Program
Primary Purpose
HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nelfinavir mesylate
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, HIV Protease Inhibitors, CD4 Lymphocyte Count, Nelfinavir, Anti-HIV Agents
Eligibility 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.
Sites / Locations
- Agouron Pharmaceuticals Inc
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00002165
First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Agouron Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00002165
Brief Title
Viracept Expanded Access Program
Official Title
Viracept Expanded Access Program
Study Type
Interventional
2. Study Status
Record Verification Date
October 1996
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Agouron Pharmaceuticals
4. Oversight
5. Study Description
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.)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Acquired Immunodeficiency Syndrome, HIV Protease Inhibitors, CD4 Lymphocyte Count, Nelfinavir, Anti-HIV Agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Nelfinavir mesylate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Agouron Pharmaceuticals Inc
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11363981
Citation
New protease inhibitor available through expanded access. Posit Aware. 1996 Nov-Dec;7(6):7.
Results Reference
background
Learn more about this trial
Viracept Expanded Access Program
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