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abacavir

Phase 3

HIV Infection | Small molecule | Infectious Disease |GSK plc|Last Updated: Sep 30, 2010

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
RandomizedUNCONTROLLED
Total Trials2
Total Enrollment930
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00094367A Study Comparing Safety Of Abacavir And Lamivudine Administered Once-Daily As A Single Tablet Versus The Same Drugs Administered Twice-Daily As Separate Tablets (ALOHA Study)PHASE3 COMPLETED 900Jul 1, 2004Oct 1, 2005Sep 30, 2010178 United States
NCT00320307Comparison of Abacavir Following Once-Daily And Twice-Daily Administration In HIV Infected SubjectsPHASE1 COMPLETED 30Sep 1, 2005 -Oct 16, 20081 United Kingdom
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Study Endpoints
Primary Endpoints
The occurrence of treatment-limiting adverse events after starting study drugs.
To assess the pharmacokinetics of intracellular CBV-TP at steady state following administration of 600 mg QD and 300 mg BID ABC-containing regimens in HIV infected adult subjects.
throughout the study
Secondary Endpoints
occurrence of abacavir HSR
completion of educational training
subject satisfaction with treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Abacavir/LamivudineDRUG -
abacavirDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites178

Inclusion Criteria: * Have HIV-1 infection. * Had not received any prior HIV treatment for more than 14 days. * At least 1000 copies of HIV-1 RNA. * Willing to provide signed informed consent. Exclusion Criteria: * Enrolled in other investigational drug studies. * Female subjects who are pregnant...

Countries:United StatesUnited Kingdom
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