Expired Study
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San Diego, California 92121


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.)


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.


Study is Available At:


Original ID:

259B


NCT ID:

NCT00002165


Secondary ID:

Study 515


Study Acronym:


Brief Title:

Viracept Expanded Access Program


Official Title:

Viracept Expanded Access Program


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

13 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

NIH AIDS Clinical Trials Information Service


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety Study, Primary Pu


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Study Dates

Verification Date:October 1996
Last Changed Date:June 23, 2005
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Nelfinavir mesylate

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Agouron Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:[No authors listed] New protease inhibitor available through expanded access. Posit Aware. 1996 Nov-Dec;7(6):7. No abstract available.
PMID:11363981

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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