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Amprenavir/ritonavir

Phase 2

HIV Infections | Small molecule | Infectious Disease |Abbott Laboratories|Last Updated: Apr 1, 2008

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 Trials2
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00038519Amprenavir/Ritonavir or Saquinavir/Ritonavir in HIV-Infected Subjects Following Failure With Kaletra as Their Second Protease InhibitorPHASE2 COMPLETED 16Apr 1, 2001 -Jul 28, 200652 United States, Argentina +8
NCT00038532Amprenavir/Ritonavir, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Subjects Following Failure With Kaletra (ABT-378/Ritonavir) as Their First Protease Inhibitor Based HAARTPHASE2 COMPLETED 24Apr 1, 2001 -Apr 1, 200854 United States, Argentina +9
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Study Endpoints
Primary Endpoints
Proportion of subjects with plasma HIV RNA levels below the limit of quantification (400 copies/mL) at week 24 and the time until loss of virologic response through week 48
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Amprenavir/ritonavirDRUG -
Saquinavir/ritonavirDRUG -
EfavirenzDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites52

Inclusion: * Subject must remain on current antiretroviral therapy during screening until a new regimen is initiated. * Subject demonstrates reduced susceptibility to lopinavir. * Subject's two most recent viral loads obtained after at least 16 weeks of lopinavir/ritonavir therapy, and while still ...

Countries:United StatesArgentinaBrazilCanadaFranceItalyPolandPuerto RicoSpainUnited KingdomGermany
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