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emtricitabine/tenofovir alafenamide

Phase 2

Acceptability of Health Care | Small molecule | Other |Gilead Sciences, Inc.|Last Updated: Jul 29, 2024

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
RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment330
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05458765Project Engage: Oral PrEP AcceptabilityPHASE2 COMPLETED 330Jun 21, 2022Jul 25, 2024Jul 29, 20243 South Africa, Zimbabwe
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Study Endpoints
Primary Endpoints
Compare the discontinuation rate between arms
3 months

Acceptability will be assessed by discontinuation of study product

Secondary Endpoints
Adherence to study product
3 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
F/TAFACTIVE_COMPARATORdaily oral tablet
F/TDFACTIVE_COMPARATORdaily oral tablet
Interventions
NameTypeDescription
emtricitabine/tenofovir alafenamideDRUG200mg/25mg tablet, once daily dosing for 24 weeks
Emtricitabine / Tenofovir Disoproxil Oral TabletDRUG200mg/300mg tablet, once daily dosing for 24 weeks
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Eligibility Criteria
Age Range15 Years — 24 Years
SexFEMALE
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: 1. Female, age 15 to 24 years (inclusive) 2. Literate, per local standards, to English and/or local language 3. In general good health, per participant reported medical history and investigator judgement, without any clinically significant systemic disease including but not limi...

Countries:South AfricaZimbabwe
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