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Efavirenz

Phase 2

HIV Infections | Small molecule | Infectious Disease |Gilead Sciences, Inc.|Last Updated: Jul 17, 2013

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 Trials2
Total Enrollment180
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00822315Efficacy and Safety of 2 Raltegravir Doses in Naive HIV-1-infected Patients Receiving Rifampin for Active TuberculosisPHASE2 COMPLETED 155Jul 1, 2009May 1, 2012Jul 17, 20139 Brazil, France
NCT00002234Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected PatientsPHASE2 COMPLETED 25 - -Jun 24, 20055 United States
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Study Endpoints
Primary Endpoints
Virologic success, using Time to Loss of Virologic Response (TLOVR) algorithm: -Plasma HIV RNA below 50 copies/ml at week 20, confirmed at week 24 -Absence of permanent treatment discontinuation -Absence of death -Still follow-up at week 24
24 weeks
Secondary Endpoints
Proportion of patients with virologic response with the following definitions: - Plasma HIV RNA <50 copies/ml at week 24 - Rate of strategy discontinuation and treatment changes - Proportion of death - Proportion of patients loss to follow-up
24 weeks
Proportion of patients with virologic response with the following definitions: o Plasma HIV RNA <50 copies/ml o Plasma HIV RNA <400 copies/ml
24 and 48 weeks
Evolution in HIV RNA and HIV DNA (total and 2 LTR circular) from baseline to week 48
48 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATORefavirenz
2EXPERIMENTALraltegravir 400 mg
3EXPERIMENTALraltegravir 800 mg
Interventions
NameTypeDescription
efavirenzDRUGtenofovir 245 mg / lamivudine 300 mg / efavirenz 600 mg
raltegravirDRUGtenofovir 245 mg / lamivudine 300 mg / raltegravir 400 mg
Adefovir dipivoxilDRUG -
LamivudineDRUG -
DidanosineDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Adult patients (at least 18 years old) * Plasma HIV RNA \> 1000 copies/ml * HIV-1-infection confirmed by ELISA and Western blot or Immunofluorescence * ART naïve patients or * ART for less than 3 months and more than 6 months ago ; an HIV resistance genotype at baseline showin...

Countries:BrazilFranceUnited States
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