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enfuvirtide

Phase 3

HIV Infections | Small molecule | Infectious Disease |Gilead Sciences, Inc.|Last Updated: Apr 7, 2026

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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment195
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00302822Intensification With Enfuvirtide in Naive HIV-infected Patients (ANRS130)PHASE3 COMPLETED 195Apr 1, 2006Dec 1, 2009Apr 7, 20261 France
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Study Endpoints
Primary Endpoints
Immunological success defined as a CD4 cell count above 200 cells per mm3 after 24 weeks of initial antiretroviral treatment
24 weeks
Secondary Endpoints
Virological response, clinical progression, tolerance,toxicity, quality of life under therapy, adherence and resistance mutations emerging in case of virological failure.
from 0 to 48 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IntensificationEXPERIMENTALlopinavir or efavirenz and emtricitabine/tenofovir and intensification with enfuvirtide (week 0 to 24)
StandardACTIVE_COMPARATORlopinavir or efavirenz and emtricitabine/tenofovir
Interventions
NameTypeDescription
enfuvirtideDRUGfrom week 0 to 24
emtricitabine/tenofovirDRUG1 pill/day
lopinavir or efavirenzDRUGinvestigator choice
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Antiretroviral naïve HIV-1 infected patients * CD4 cell count below 100 per mm3, or CD4 cell count below 200/mm3 and past history or presence of B or C(AIDS defining)event * Signed informed consent Exclusion Criteria: * Pregnancy; breast feeding * Coinfection with HIV-2 or i...

Countries:France
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