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Efavirenz

Phase 4FDA approved

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

Efavirenz development status

FDA approval on record Sep 17, 1998
Approval holderBristol Myers Squibb
ApplicationNDA020972
Highest phase Phase 4 (NCT00224458)
Phase scored for GILDPhase 2
Registered trials 92 across 30 sponsors since Nov 1999

Efavirenz target and mechanism

ModalitySmall molecule

Also known as Efavirenz (EFV)

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials3
Total Enrollment205

FDA Designations

No designations recorded

Efavirenz clinical trials

Efavirenz · 3 trials · 2 indications

Phase 2 3
NCT00822315Efficacy and Safety of 2 Raltegravir Doses in Naive HIV-1-infected Patients Receiving Rifampin for Active TuberculosisHIV Infections
COMPLETED155 Analytics
NCT00002234Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected PatientsHIV Infections
COMPLETED25 Analytics
NCT00002419Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor TreatmentHIV Infections
COMPLETED25 Analytics
PHASE2COMPLETED
Efficacy and Safety of 2 Raltegravir Doses in Naive HIV-1-infected Patients Receiving Rifampin for Active Tuberculosis
HIV InfectionsUnlock trial analytics
PHASE2COMPLETED
Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients
HIV InfectionsUnlock trial analytics
PHASE2COMPLETED
Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor Treatment
HIV InfectionsUnlock trial analytics

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 -
Abacavir sulfateDRUG -
AmprenavirDRUG -
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Eligibility Criteria

Age Range18 Years to 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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Frequently asked questions about Efavirenz

What is Efavirenz used for?

Efavirenz is used to treat HIV Infections. It is an antiretroviral small molecule studied as part of combination regimens in HIV-infected patients, including treatment-experienced patients and those receiving rifampin for active tuberculosis. The clinical trials listed for Efavirenz enrolled adults and adolescents with HIV Infections.

Who makes Efavirenz?

Efavirenz is developed by Gilead Sciences, Inc., which trades under the ticker GILD. The company is listed as the developer of the Efavirenz program in HIV Infections.

What phase is Efavirenz in?

Efavirenz is in Phase 2 clinical development for HIV Infections. Three Phase 2 trials are registered, of which two are completed and none are currently active. The completed studies together enrolled 205 participants.

What clinical trials is Efavirenz in?

Registered Efavirenz trials include NCT00822315, which studied two raltegravir doses in naive HIV-1-infected patients receiving rifampin for active tuberculosis, and NCT00002419 and NCT00002234, which evaluated anti-HIV drug combinations including Efavirenz in HIV-infected patients. All three Phase 2 trials are completed.

Is Efavirenz the same as EFV?

Yes, Efavirenz is also known as Efavirenz (EFV), so EFV is simply the abbreviated name for the same drug. Searches for either name refer to the same small molecule developed by Gilead Sciences for HIV Infections.

How were the Efavirenz trials designed?

The Efavirenz Phase 2 trials were randomized and active controlled, and none were double blind. Enrollment ranged from 25 to 155 participants. The studies took place in the United States, Brazil, and France, and enrolled patients aged 13 years and older, with no healthy volunteers.