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Pitavastatin

Phase 3

HIV | Small molecule | Infectious Disease |Gilead Sciences, Inc.|Last Updated: Sep 4, 2025

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-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment7,769
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02344290Evaluating the Use of Pitavastatin to Reduce the Risk of Cardiovascular Disease in HIV-Infected AdultsPHASE3 COMPLETED 7,769Mar 26, 2015Aug 21, 2023Sep 4, 2025137 United States, Botswana +11
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Study Endpoints
Primary Endpoints
Incidence Rate of Major Adverse Cardiovascular Event (MACE)
From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).

MACE is a composite of cardiovascular (CV) death, myocardial infarction, hospitalization for unstable angina, stroke, transient ischemic attack (TIA), peripheral arterial ischemia, coronary, carotid or peripheral arterial revascularization, or death from an undetermined cause. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via cause-specific relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Non-CV deaths (without preceding event of interest) were treated as competing events and censored. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy).

Secondary Endpoints
Incidence Rate of Cardiac Ischemia or Myocardial Infarction
From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).
Incidence Rate of Cerebrovascular Event (Stroke or TIA)
From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).
Incidence Rate of Peripheral Arterial Ischemia
From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
PitavastatinEXPERIMENTALParticipants received pitavastatin once a day for the entire time they were in study follow-up.
PlaceboPLACEBO_COMPARATORParticipants received placebo for pitavastatin once a day for the entire time they were in study follow-up.
Interventions
NameTypeDescription
PitavastatinDRUGOne tablet (4 mg) taken once daily, orally with or without food
PlaceboDRUGOne tablet taken once daily, orally with or without food
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Eligibility Criteria
Age Range40 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites137

Inclusion Criteria: * Individual with HIV-1 * Combination antiretroviral therapy (ART) for at least 180 days prior to study entry * CD4+ cell count greater than 100 cells/mm\^3 * Acceptable screening laboratories including: * Fasting low-density lipoprotein (LDL) cholesterol as follows: * I...

Countries:United StatesBotswanaBrazilCanadaHaitiIndiaPeruPuerto RicoSouth AfricaSpainThailandUgandaZimbabwe
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