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Isentress

Phase 3

HIV Infections | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: May 12, 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
RandomizedNO_TREATMENT_CONTROLLEDBiomarker
Total Trials1
Total Enrollment17
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00935480IntensVIH: Impact Of Therapy Intensification By An Integrase Inhibitor +/- CCR5 Inhibitor On The Lymphoid Reservoir For Hiv-1 In Chronically Infected PatientsPHASE3 COMPLETED 17Oct 1, 2010Aug 8, 2014May 12, 20172 France
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Study Endpoints
Primary Endpoints
residual plasma replication between 0 and 50 copies/ml
one year
intracellular HIV RNA levels in circulating lymphocytes (PBMC) and lymphocytes in gut-associated rectal lymphoid tissue (RL
one year
proviral HIV DNA levels in PBMC and RL
one year
Secondary Endpoints
CD4 counts
one year
CD8 activation levels
one year
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
HAART+Raltegravir 12 months (+/-) MaravirocEXPERIMENTAL -
HAARTNO_INTERVENTION -
Interventions
NameTypeDescription
Isentress®DRUGP.O, 1 tablet containing 400 mg every 12 hours
Celsentri®DRUGp.o.: 1 tablet containing 150 mg morning and evening (due to combination with PI/r) or containing 300 mg if fosamprenavir/r is used as the PI (MA)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Male or female patients, aged over 18 years * HIV infection confirmed by Western Blot * Karnofsky score \> 80% * Treatment-experienced patients having received combined antiretroviral therapy including at least 2 RTI and 1 PI/r for at least 12 months with plasma viral load \<5...

Countries:France
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