Recent Updates
Recently added Catalysts

Indinavir

Phase 3

HIV Infections | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Jun 24, 2005

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDBiomarker
Total Trials7
Total Enrollment918
FDA Designations
No designations recorded
Clinical Trials (7)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00002208A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 Mg q 8 h Versus 1,200 Mg q 12 h in Combination With Zidovudine and 3TCPHASE3 COMPLETED 400 - -Jun 24, 200515 United States
NCT00002220Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success With NelfinavirPHASE3 COMPLETED 120 - -Jun 24, 200511 United States
NCT00002406A Comparison of Two Dose Levels of Indinavir Combined With Two Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTIs) in HIV-Infected PatientsPHASE3 COMPLETED 350 - -Jun 24, 200529 United States
NCT00002410A Study of Three Different Anti-HIV Drug Combinations in HIV-Infected PatientsPHASE3 COMPLETED - - -Jun 24, 200541 United States, Puerto Rico
NCT00002235A Study on the Safety and Effectiveness of Twice-Daily Nelfinavir Plus Twice-Daily Indinavir Plus Efavirenz in HIV-Positive Patients Who Have Never Taken Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease InhibitorsPHASE2 COMPLETED 6 - -Jun 24, 20055 United States
NCT00002361Safety and Effectiveness of an Anti-HIV Drug Combination in HIV-Positive Patients Who Have Failed Previous Treatment With Protease InhibitorsPHASE2 COMPLETED 30 - -Jun 24, 20058 United States
NCT00002351A Study of L-735,524 in HIV-Positive Children and AdolescentsPHASE1 COMPLETED 12 - -Jun 24, 20051 United States
Unlock Drug Trial Details
Study Design & Arms
PurposeTREATMENT
Interventions
NameTypeDescription
Indinavir sulfateDRUG -
LamivudineDRUG -
StavudineDRUG -
ZidovudineDRUG -
EfavirenzDRUG -
LevocarnitineDRUG -
Adefovir dipivoxilDRUG -
Nelfinavir mesylateDRUG -
RitonavirDRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range16 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria Patients must have: * HIV-1 seropositive status. * CD4 count greater than 100 cells/mm3. * Viral RNA above 10,000 copies/mL. * Consent from parent or guardian if less than 18 years of age. Exclusion Criteria Prior Medication: Excluded: * Prior therapy with protease inhibitor...

Countries:United StatesPuerto Rico
Unlock Eligibility Criteria