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MK0831

Phase 3

HIV Infections | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Nov 30, 2015

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 Trials1
Total Enrollment -
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00543530Pediatric Expanded Access Program-Oral Solution (0831-908)PHASE3 COMPLETED -Mar 1, 2001Dec 1, 2002Nov 30, 2015 -
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
MK0831DRUG -
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Eligibility Criteria
Age Range3 Years — 16 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Not tolerating current ART regime laboratory status is stable * Able to take oral liquid medications but have difficulty swallowing capsules * Weigh at least 10 kg (22 lbs) Exclusion Criteria: * Has had more than 2 episodes of moderate to severe diarrhea or vomiting lasting ...

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