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Nelfinavir

Phase 3

HIV Infections | Small molecule | Infectious Disease |Roche Holding AG|Last Updated: Jun 24, 2005

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials5
Total Enrollment1,372

FDA Designations

No designations recorded

Clinical trial landscape

Nelfinavir · 5 trials · 2 indications

Phase 3 4Phase 1 1
NCT00002178A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination With Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive PatientsHIV Infections
COMPLETED375 Analytics
NCT00002374A Study of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs in HIV-1 Infected PatientsHIV Infections
COMPLETED120 Analytics
NCT00002378A Comparison of Three Anti-HIV Drug Combinations Containing Saquinavir Soft Gelatin Capsules Used in HIV-1 Infected PatientsHIV Infections
COMPLETED825 Analytics
NCT00002397A Study of Saquinavir Soft Gel Capsules (SGC) Used in Combination With Two Other Anti-HIV Drugs in Patients With HIV-Associated Kidney DiseaseHIV Infections
COMPLETED24 Analytics
PHASE3COMPLETED
A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination With Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients
HIV InfectionsUnlock trial analytics
PHASE3COMPLETED
A Study of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs in HIV-1 Infected Patients
HIV InfectionsUnlock trial analytics
PHASE3COMPLETED
A Comparison of Three Anti-HIV Drug Combinations Containing Saquinavir Soft Gelatin Capsules Used in HIV-1 Infected Patients
HIV InfectionsUnlock trial analytics
PHASE3COMPLETED
A Study of Saquinavir Soft Gel Capsules (SGC) Used in Combination With Two Other Anti-HIV Drugs in Patients With HIV-Associated Kidney Disease
HIV InfectionsUnlock trial analytics

Study Design & Arms

PurposeTREATMENT

Interventions

NameTypeDescription
RitonavirDRUG -
Nelfinavir mesylateDRUG -
SaquinavirDRUG -
Delavirdine mesylateDRUG -
StavudineDRUG -
LamivudineDRUG -
ZidovudineDRUG -
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Eligibility Criteria

Age Range16 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria Patients must have: * HIV RNA \>= 5000 copies/ml by Amplicor assay. * Signed, informed consent from parent or legal guardian for patients less than 18 years old. Previous treatment with antiretrovirals.

Countries:United StatesGermanyItalyPuerto RicoSpainUnited Kingdom
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Frequently asked questions about Nelfinavir

What is Nelfinavir used for?

Nelfinavir is an investigational small molecule being developed for the treatment of HIV Infections. It is currently in Phase 3 clinical development, though all five recorded trials have been completed. The drug is being studied in combination with other antiretroviral therapies in HIV-1 infected patients.

Who makes Nelfinavir?

Nelfinavir is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials for this small molecule drug candidate in the infectious disease therapeutic area, specifically targeting HIV Infections.

What phase is Nelfinavir in?

Nelfinavir is in Phase 3 clinical development. However, all five clinical trials associated with the drug have been completed, with no active trials currently ongoing. The completed trials enrolled a total of 1,372 participants across various studies.

What clinical trials is Nelfinavir in?

Nelfinavir has been studied in five completed clinical trials, including NCT00002178, NCT00002374, NCT00002378, and NCT00002380. These trials evaluated the drug in combination with other antiretrovirals in HIV-1 infected patients, including a pediatric study. The trials were conducted primarily in the United States and other countries.

Is Nelfinavir FDA approved?

Nelfinavir is an investigational drug and is not FDA approved. It is currently in Phase 3 clinical development, but all recorded trials have been completed. The drug has not received approval for the treatment of HIV Infections and remains under investigation.