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Rilpivirine/Emtricitabine/Tenofovir

Phase 2

HIV | Small molecule | Infectious Disease |Gilead Sciences, Inc.|Last Updated: Mar 17, 2021

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment150
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02104700Switch From Nevirapine-based Regimen to Once a Day Rilpivirine/Emtricitabine/TenofovirPHASE2 COMPLETED 150Apr 1, 2014Jul 1, 2016Mar 17, 20211 Rwanda
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Study Endpoints
Primary Endpoints
Explore Efficacy
24 weeks

To compare proportion of subjects successfully maintaining a plasma viral load \<200 copies /mL at week 24 in subjects randomized to rilpivirine/emtricitabine/tenofovir vs. in those randomized to initially continue nevirapine-based ART in this pilot study.

Secondary Endpoints
HIV RNA levels
24 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Rilpivirine/Emtricitabine/TenofovirACTIVE_COMPARATOR"Immediate switch": RILPIVIRINE/ EMTRICITABINE /TENOFOVIR FDC QDAY at randomization.
Nevirapine/Lamivudine/ plus other NNRTIACTIVE_COMPARATOR"Delayed switch": Continue NEVIRAPINE 200MG BID + LAMIVUDINE 300MG + OTHER NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR (NRTI) through 24 weeks then switch to RILPIVIRINE 25MG/ EMTRICITABINE 200MG/TENOFOVIR 300MG FDC QDAY and then follow through 48 weeks.
Interventions
NameTypeDescription
Rilpivirine/Emtricitabine/TenofovirDRUGRilpivirine 25mg/Emtricitiabine 200mg/Tenofovir 300mg FDC qday
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. A second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test or a previous detectable HIV RNA level * HIV RNA ...

Countries:Rwanda
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