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maraviroc

Phase 2

HIV-1 Infection | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Sep 5, 2014

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00993148Maraviroc Plus Darunavir/Ritonavir for Treatment-Naïve Patients Infected With R5-tropic HIV-1PHASE2 COMPLETED 25May 1, 2010Apr 1, 2013Sep 5, 20145 United States
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Study Endpoints
Primary Endpoints
Percentage of Participants With Plasma HIV-1 RNA >50
24 weeks

Percentage of participants with confirmed plasma HIV-1 RNA \> 50 copies/mL

Secondary Endpoints
Percentage of Participants With Virologic Failure or Off Study Treatment Regimen
24 weeks
Percentage of Participants With Plasma HIV-1 RNA >50 Copies/mL
48 weeks
Signs/Symptoms or Laboratory Toxicities of Grade 3 or Higher
96 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Maraviroc plus darunavir/ritonavirEXPERIMENTALSingle arm open label trial of maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily for 96 weeks
Interventions
NameTypeDescription
maravirocDRUG150 mg tab by mouth once daily for 96 weeks
darunavirDRUG800 mg tab by mouth once daily for 96 weeks
ritonavirDRUG100 mg capsule by mouth once daily for 96 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * HIV-1 infection, as documented by any licensed HIV test kit and confirmed by Western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA any time prior to study entry * Plasma HIV-1 RNA 5, 000 to 500,000 copies/mL obtain...

Countries:United States
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