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Pegylated Interferon alpha 2b

Phase 2

HIV-1 Infection | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Jul 6, 2023

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 Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01935089Pilot Peg-Interferon-a2b in Decreasing Viral DNA in HIVPHASE2 COMPLETED 20Aug 7, 2013May 2, 2016Jul 6, 20233 United States
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Study Endpoints
Primary Endpoints
Change From Baseline in Copies of HIV DNA Per CD4+ T Cell at Week 24
Week 3 and 24

Difference in copies of HIV DNA per CD4+ T cell between baseline and week 24, assessed by Alu-HIVgag polymerase chain reaction

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Interferon alphaEXPERIMENTALpegylated Interferon alpha 2b (Pegintron) 1 µg/kg per week, 20 weeks
Interventions
NameTypeDescription
Pegylated Interferon alpha 2bDRUG1µg/kg/week
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * 18-65 years of age * Body weight between 125 and 299 lbs * Confirmed diagnosis of HIV-1 infection by western blot or by a documented HIV-1 viral load * Currently receiving ART and on ART for \> 1 year * VL \< 50 copies/ml for ≥ 1 year, with at least 2 measurements in the previ...

Countries:United States
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