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Comparator: raltegravir

Phase 3

Human Immunodeficiency Virus | Small molecule | Other |Merck & Company, Inc.|Last Updated: Mar 21, 2017

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
UNCONTROLLED
Total Trials1
Total Enrollment209
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00764946A Study of Raltegravir in a Diverse Cohort of HIV-Infected Patients (0518-055)PHASE3 COMPLETED 209 — — Oct 1, 2008Feb 1, 2011Mar 21, 2017 - —
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Study Endpoints
Primary Endpoints
Number of Participants Who Achieved HIV Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
Week 48

Numbers of participants with HIV RNA copies \<50 copies/mL were summarized by race for each time point.

Number of Participants With One or More Adverse Events
Week 48

Numbers of participants with one or more adverse events were summarized by race.

Number of Participants Who Discontinued Due to an Adverse Event
Week 48

Numbers of participants who discontinued due to an adverse event were summarized by race.

Secondary Endpoints
Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48
Week 48
Mean Change From Baseline to Week 48 in HIV RNA
Baseline and Week 48
Mean Change From Baseline to Week 48 in CD4 Cell Count
Baseline and Week 48
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALraltegravir
Interventions
NameTypeDescription
Comparator: raltegravirDRUG400 mg tablets taken twice daily. Total treatment period is 48 weeks.
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Eligibility Criteria
Age Range16 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patient is HIV positive * Patient agrees to use (or have their partner use) birth control as defined by the study doctor Exclusion Criteria: * If female, pregnant or breastfeeding * Patient has used an investigational agent in the last 30 days * Patient has acute hepatitis *...

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