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Nelfinavir

Phase 2

HIV Infections | Small molecule | Infectious Disease |Gilead Sciences, Inc.|Last Updated: Jun 24, 2005

Success Probability

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Market & Valuation

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Trial Design

Double-BlindUNCONTROLLED
Total Trials1
Total Enrollment120

FDA Designations

No designations recorded

Clinical trial landscape

Nelfinavir · 1 trial · 1 indication

Phase 2 1
NCT00002184A Phase II, Stratified, Randomized, Double-Blind, Multi-Center Study of the Safety and Efficacy of Adefovir Dipivoxil (ADF) at Two Dose Levels in Triple Combination Therapies With Protease Inhibitors (PI) and Nucleoside Reverse Transcriptase Inhibitors (RTI) for the Treatment of HIV-Infected PatientHIV Infections
COMPLETED120 Analytics
PHASE2COMPLETED
A Phase II, Stratified, Randomized, Double-Blind, Multi-Center Study of the Safety and Efficacy of Adefovir Dipivoxil (ADF) at Two Dose Levels in Triple Combination Therapies With Protease Inhibitors (PI) and Nucleoside Reverse Transcriptase Inhibitors (RTI) for the Treatment of HIV-Infected Patient
HIV InfectionsUnlock trial analytics

Study Design & Arms

MaskingDOUBLE
PurposeTREATMENT

Interventions

NameTypeDescription
Nelfinavir mesylateDRUG -
LevocarnitineDRUG -
Adefovir dipivoxilDRUG -
SaquinavirDRUG -
LamivudineDRUG -
StavudineDRUG -
ZidovudineDRUG -
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Eligibility Criteria

Age Range16 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria Patients must have: * Laboratory diagnosis of HIV infection (positive HIV antibody test confirmed by Western blot, p24 antigen assay, HIV-1 RNA, or HIV-1 culture). * An HIV-1 RNA plasma titer \>= 5000 copies/ml within 14-21 days prior to the baseline visit. * CD4 cell count \>= ...

Countries:United StatesPuerto Rico
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Frequently asked questions about Nelfinavir

What is Nelfinavir used for in HIV Infections?

Nelfinavir is an investigational small molecule being studied for the treatment of HIV Infections. It is currently in Phase 2 clinical development. The drug is being evaluated in combination with other antiretroviral therapies, including protease inhibitors and nucleoside reverse transcriptase inhibitors, for HIV-infected patients.

Who makes Nelfinavir?

Nelfinavir is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is conducting clinical research to evaluate the safety and efficacy of Nelfinavir in patients with HIV Infections.

What phase is Nelfinavir in?

Nelfinavir is in Phase 2 clinical development for the treatment of HIV Infections. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial has been completed to evaluate its safety and efficacy in HIV-infected patients.

What clinical trials is Nelfinavir in?

Nelfinavir has been studied in one completed Phase 2 clinical trial, identified as NCT00002184. This was a stratified, randomized, double-blind, multi-center study that enrolled 120 HIV-infected patients in the United States and Puerto Rico. The trial evaluated Nelfinavir in triple combination therapies with protease inhibitors and nucleoside reverse transcriptase inhibitors.

Is Nelfinavir the same as Adefovir Dipivoxil?

No, Nelfinavir is not the same as Adefovir Dipivoxil. The completed clinical trial NCT00002184 evaluated Adefovir Dipivoxil at two dose levels in combination with protease inhibitors and nucleoside reverse transcriptase inhibitors for HIV treatment. Nelfinavir is a separate investigational drug being developed by Gilead Sciences for HIV Infections.