Completed

Nelfinavir Mesylate (Viracept) Access for HIV-Positive Patients with Low CD4 Count

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What is being tested

Nelfinavir mesylate

Drug
Who is being recruted

Blood-Borne Infections+13

+ Urogenital Diseases

+ Genital Diseases

Over 13 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorAgouron Pharmaceuticals
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

The study focuses on providing a drug called nelfinavir mesylate (Viracept) to HIV positive patients. This is specifically for those who can't take the three commercially available protease inhibitors due to various reasons like failure, intolerance, or contraindication. The study also targets patients with a CD4 cell count of 50 or less. The goal is to help these patients manage their condition better, especially since they have limited treatment options. The study also aims to gather more information on the safety of using nelfinavir mesylate (Viracept). Participants in the study will receive nelfinavir mesylate (Viracept) as part of their treatment. The study will monitor the safety of the drug and its effects on the participants. It's important to note that participants who can't take indinavir and/or ritonavir due to intolerance, contraindication, or prior failure are now eligible for the Viracept Program.

NCT00002165
Principal SponsorAgouron Pharmaceuticals
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 13 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeHIV Infections

Criteria

4 inclusion criteria required to participate
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)

Patients must have HIV infection

People now qualify for the Viracept Program if they are unable to take indinavir and/or ritonavir due to intolerance, contraindication or prior failure

4 exclusion criteria prevent from participating
Indinavir required

Prior therapy with Viracept

Ritonavir required

Saquinavir required

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Agouron Pharmaceuticals Inc

San Diego, United StatesOpen Agouron Pharmaceuticals Inc in Google Maps
CompletedOne Study Center