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abacavir/lamivudine

Phase 3

Infection, Human Immunodeficiency Virus I | Small molecule | Infectious Disease |GSK plc|Last Updated: Mar 24, 2020

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
RandomizedUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment406
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00046176A HIV Study Of A Fixed-Dose Combination Tablet In Antiretroviral Experienced PatientsPHASE3 COMPLETED 240Aug 26, 2002May 17, 2004Mar 24, 202056 United States, Costa Rica +2
NCT00044577New Tablet Containing Two FDA Approved Anti-HIV Drugs For Antiretroviral Therapy Experienced HIV-1 Infected SubjectsPHASE3 COMPLETED 166Jul 16, 2002May 25, 2004Mar 24, 202076 United States, Belgium +7
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Study Endpoints
Primary Endpoints
Proportion of non-virologic failures through Week 48. Treatment-limiting adverse events over 48 weeks.
48 weeks
HIV viral load response as measured by change from baseline in HIV-1 RNA over 24 and 48 weeks. Safety
48 weeks
Secondary Endpoints
Viral load response at Week 24 and 48 T-cell count Disease progression Health outcomes Resistance
48 weeks
Viral load response T-cell count Health Outcomes Resistance
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
abacavir/lamivudineDRUG -
abacavirDRUG -
lamivudineDRUG -
tenofovirDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites56

Inclusion Criteria: * Currently receiving an initial antiretroviral therapy (ART) regimen composed of the drug abacavir (ABC) 300mg twice a day, plus the drug 3TC (lamivudine) 150mg twice a day in combination with either a protease inhibitor or non-nucleoside reductase inhibitor (NNRTI) for at leas...

Countries:United StatesCosta RicaPanamaPuerto RicoBelgiumCanadaFranceGermanyItalyPortugalSpainUnited Kingdom
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