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Efavirenz

Phase 3

HIV Infections | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Sep 7, 2015

Success Probability

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Market & Valuation

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Trial Design

Double-BlindUNCONTROLLED
Total Trials1
Total Enrollment730

FDA Designations

No designations recorded

Clinical trial landscape

Efavirenz · 2 trials · 2 indications

Phase 3 1Phase 1 1
NCT00005918Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected PatientsHIV Infections
COMPLETED730 Analytics
PHASE3COMPLETED
Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Difference from placebo of Efavirenz (EFV) in change from period-specific baseline in the QT interval corrected for heart rate (HR) via Fridericia's method (QTcF) at postdose extraction times (ΔΔQTcF)
Days 1, 2, 5, 6, 19 and 20

QTcF = QT corrected for Fridericia's formula

Secondary Endpoints

Difference from placebo of EFV in change from period-specific baseline in other ECG parameters: HR, PR, QRS, and uncorrected QT following 14 days of dosing
Days 1, 5 and 19
Difference from placebo of Moxifloxacin in change from period-specific baseline in QTcF (ΔΔQTcF) following a single dose
Days 1, 5 and 19
Number and percent of subjects having a maximum QTcF, HR, PR, and QRS outside of pre-specified categories and those having a maximum ΔQTcF outside of pre-specified categories
Days 1, 5 and 19
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Study Design & Arms

MaskingDOUBLE
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Moxifloxacin, Placebo, EfavirenzEXPERIMENTALMoxifloxacin, Placebo, Efavirenz single dose as specified

Interventions

NameTypeDescription
EfavirenzDRUG -
LamivudineDRUG -
StavudineDRUG -
MoxifloxacinDRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites77

Inclusion Criteria Patients may be eligible for this study if they: * Are at least 18 years old. Patients living in USA, Puerto Rico, Australia, Brazil, Singapore, and Thailand can be at least 12 years old (need consent of parent or guardian if under 18). * Have a viral load of at least 2,000 copi...

Countries:United StatesArgentinaAustraliaBelgiumBrazilCanadaFranceIsraelItalyMexicoPortugalPuerto RicoRussiaSouth AfricaSpainThailand
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Frequently asked questions about Efavirenz

What is Efavirenz used for?

Efavirenz is used for HIV infections and HIV/AIDS. It is a small molecule being developed by Bristol-Myers Squibb Company for the treatment of these infectious disease conditions. The drug has been studied in clinical trials involving patients with HIV infections.

Who makes Efavirenz?

Efavirenz is developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company has conducted clinical trials to evaluate the drug's effectiveness and safety in treating HIV infections and HIV/AIDS.

What phase is Efavirenz in?

Efavirenz is in Phase 3 clinical development. It has completed one Phase 3 trial with 730 participants and one Phase 1 trial with 58 healthy volunteers. The drug remains investigational and is not yet approved for commercial use.

What clinical trials is Efavirenz in?

Efavirenz has been studied in two completed trials. NCT00005918 was a Phase 3 study of stavudine forms in HIV-infected patients with 730 participants. NCT02164812 was a Phase 1 study of Efavirenz's effect on ECG QTcF interval in healthy subjects with 58 participants.

How does Efavirenz work?

Efavirenz is a small molecule developed for HIV infections. As a non-nucleoside reverse transcriptase inhibitor, it works by blocking the reverse transcriptase enzyme that HIV needs to replicate. This mechanism helps reduce viral load in patients with HIV/AIDS.