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Efavirenz

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment180

FDA Designations

No designations recorded

Clinical trial landscape

Efavirenz · 2 trials · 2 indications

Phase 2 2
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
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

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 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 in HIV Infections?

Efavirenz is a small molecule being developed for the treatment of HIV Infections. It is currently in Phase 2 clinical development and is being studied in combination with other antiretroviral drugs. The drug is intended for use in HIV-infected patients, including those with active tuberculosis.

What does Efavirenz target?

Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that targets the reverse transcriptase enzyme of HIV-1. By binding to this enzyme, it blocks the replication of the virus. This mechanism is being evaluated in clinical trials for the treatment of HIV infections.

Who makes Efavirenz?

Efavirenz is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is conducting Phase 2 clinical trials to evaluate the drug's safety and efficacy in HIV-infected patients.

What phase is Efavirenz in?

Efavirenz is currently in Phase 2 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. Two Phase 2 clinical trials have been completed, with a total enrollment of 180 patients, to assess its safety and effectiveness.

What clinical trials is Efavirenz in?

Efavirenz has been studied in two completed Phase 2 clinical trials. NCT00002234 evaluated a once-daily combination of adefovir dipivoxil, didanosine, efavirenz, and lamivudine in 25 HIV-infected patients in the United States. NCT00822315 assessed two doses of raltegravir in 155 HIV-1-infected patients receiving rifampin for active tuberculosis in Brazil and France.

Is Efavirenz the same as Sustiva?

Efavirenz is also known by the brand name Sustiva. It is a non-nucleoside reverse transcriptase inhibitor used in the treatment of HIV infections. The drug is being developed by Gilead Sciences and is currently in Phase 2 clinical trials for this indication.