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abacavir/3TC/zidovudine

Phase 2

AIDS-related Kaposi's Sarcoma | Small molecule | Oncology |Abbott Laboratories|Last Updated: Oct 30, 2014

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
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment49
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00834457A Pilot Study Of the Effects of Highly Active Antiretroviral Therapy on Kaposi's Sarcoma in ZimbabwePHASE2 COMPLETED 49Jun 1, 2007Jul 1, 2009Oct 30, 20141 Zimbabwe
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Study Endpoints
Primary Endpoints
Compare effects of twice-daily all-(NRTI) antiretroviral regimen to a once-daily regimen of 2 NRTIs plus a protease inhibitor AIDS-KS subjects with good virologic suppression on all-NRTI regimen.
96 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
2AACTIVE_COMPARATORco-formulated abacavir 300mg/3TC 150mg/zidovudine 300mg po(Trizivir)one tablet twice daily(BID)for 96 weeks
2BACTIVE_COMPARATORco-formulated abacavir 600mg/3TC 300mg orally (as Kivexa) one tablet daily plus fixed dose lopinavir 133.3mg/ritonavir 33.3mg orally (as Aluvia) four tablets daily for 96 weeks
Interventions
NameTypeDescription
abacavir/3TC/zidovudineDRUGcontinued use of oral co-formulated abacavir 300mg/3TC 150mg/zidovudine 300mg for 96 weeks
abacavir /3TC plus ritonavir boosted lopinavirDRUGfixed dose abacavir 600mg/3TC 300mg one tablet po QD for 96 weeks plus fixed dose ritonavir 33.3mg/lopinavir 133.3mg four tablets po QD for 96 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria:Completion of at least 96 weeks of treatment with ABC/3TC/ZDV on protocol Step 1. * Currently receiving ABC/3TC/ZDV on Step 1/initial open-label allNRTI phase of study. * Plasma HIV-1 RNA \< 400 copies/mL on the most recent plasma HIV-1 RNA performed within 4 weeks of Step 2 entr...

Countries:Zimbabwe
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