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Nelfinavir

Phase 2

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
Double-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment120
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
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 PatientPHASE2 COMPLETED 120 - -Jun 24, 200515 United States, Puerto Rico
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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 — 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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