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NCT00002165 Clinical Trial

Viracept Expanded Access Program

HIV Infections Clinical Trial

Official title:
Viracept Expanded Access Program

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00002165
Other study ID # 259B
Secondary ID Study 515AG1343
Status Completed
Phase N/A
First received November 2, 1999
Last updated June 23, 2005

Study information
Verified date October 1996
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.)

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility 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 Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Nelfinavir mesylate

Locations
Country Name City State
United States Agouron Pharmaceuticals Inc San Diego California

Sponsors (1)
Lead Sponsor Collaborator
Agouron Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

New protease inhibitor available through expanded access. Posit Aware. 1996 Nov-Dec;7(6):7. — View Citation

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