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Indinavir

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00002379The Safety and Effectiveness of Adefovir Dipivoxil Plus Indinavir Combined With Zidovudine or Lamivudine or Stavudine in HIV-Infected Patients Who Have Not Taken Anti-HIV DrugsPHASE2 COMPLETED 100 - -Jun 24, 200515 United States, Puerto Rico
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Study Design & Arms
PurposeTREATMENT
Interventions
NameTypeDescription
Indinavir sulfateDRUG -
LevocarnitineDRUG -
Adefovir dipivoxilDRUG -
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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