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stavudine, lamivudine, efavirenz

Phase 3

HIV Infections | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Apr 25, 2011

Target and mechanism

ModalitySmall molecule

Also known as stavudine extended-release, lamivudine, efavirenz

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment300

FDA Designations

No designations recorded

Clinical trial landscape

stavudine, lamivudine, efavirenz · 1 trial · 1 indication

Phase 3 1
NCT00135369Switching HIV-1 Infected Subjects From a Highly Active Anti-Retroviral Treatment (HAART) Regimen Dosed Twice Daily or More Frequently to a Once-Daily RegimenHIV Infections
COMPLETED300 Analytics
PHASE3COMPLETED
Switching HIV-1 Infected Subjects From a Highly Active Anti-Retroviral Treatment (HAART) Regimen Dosed Twice Daily or More Frequently to a Once-Daily Regimen
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Efficacy at week 48

Secondary Endpoints

Safety, tolerability and efficacy at weeks (wks) 24 and 48; Effect on lipids at wks 24 and 48; Adherence, quality of life changes, treatment satisfaction and preference at wks 12, 24 and 48
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
stavudine extended-release, lamivudine, efavirenzDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites47

Inclusion Criteria: * Documented HIV infection * 18 years of age or older and weigh at least 40 kg * Two plasma HIV RNA levels below the limit of quantification (one at least 90 days prior to the screening visit and one within 30 days of the patients baseline visit) * Currently receiving a standard...

Countries:United StatesPuerto Rico
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Frequently asked questions about stavudine, lamivudine, efavirenz

What is stavudine, lamivudine, efavirenz used for?

Stavudine, lamivudine, efavirenz is a once-daily combination antiretroviral regimen being studied for the treatment of HIV-1 infection. It combines three small molecule antivirals in a single daily dosing schedule, and was evaluated in a Phase 3 trial of switching HIV-1 infected adults from a more frequent HAART regimen.

Who is developing stavudine, lamivudine, efavirenz?

Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY, is the developer of the stavudine, lamivudine, efavirenz combination regimen.

What phase is stavudine, lamivudine, efavirenz in?

Stavudine, lamivudine, efavirenz reached Phase 3 development. The combination is investigational and is not described as approved. One Phase 3 trial has been completed, and no trials of this regimen are currently active.

What clinical trials is stavudine, lamivudine, efavirenz in?

Stavudine, lamivudine, efavirenz was studied in one completed Phase 3 trial, NCT00135369, titled Switching HIV-1 Infected Subjects From a Highly Active Anti-Retroviral Treatment (HAART) Regimen Dosed Twice Daily or More Frequently to a Once-Daily Regimen. It enrolled 300 adults aged 18 and older in the United States and Puerto Rico.

Is stavudine, lamivudine, efavirenz the same as stavudine extended-release, lamivudine, efavirenz?

Yes. Stavudine extended-release, lamivudine, efavirenz is another name for the same combination regimen. Both names refer to the once-daily three-drug HIV-1 treatment developed by Bristol-Myers Squibb.

How was the stavudine, lamivudine, efavirenz trial designed?

The Phase 3 trial NCT00135369 was a randomized study with 300 participants, comparing a switch to once-daily dosing against the prior HAART regimen dosed twice daily or more often. It was not double-blind and used an uncontrolled design, and it has been completed.