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Viracept Expanded Access Program

NCT ID: NCT00002165

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.)

Detailed Description

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Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Nelfinavir mesylate

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agouron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Locations

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Agouron Pharmaceuticals Inc

San Diego, California, United States

Site Status

Countries

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United States

References

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

Reference Type BACKGROUND
PMID: 11363981 (View on PubMed)

Other Identifiers

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Study 515

Identifier Type: -

Identifier Source: secondary_id

AG1343 - 515

Identifier Type: -

Identifier Source: secondary_id

259B

Identifier Type: -

Identifier Source: org_study_id