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stavudine, lamivudine, efavirenz

Phase 3

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

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, and efavirenz are used for the treatment of HIV infections. This combination of small molecule antiretroviral drugs was studied as a once-daily regimen for HIV-1 infected subjects. The investigational combination was evaluated in a Phase 3 clinical trial.

Who makes stavudine, lamivudine, efavirenz?

Bristol-Myers Squibb Company (ticker: BMY) is the developer of the stavudine, lamivudine, and efavirenz combination. The company conducted a Phase 3 clinical trial of this antiretroviral regimen for HIV infections.

What phase is stavudine, lamivudine, efavirenz in?

Stavudine, lamivudine, and efavirenz is in Phase 3 clinical development. The combination was studied in a completed Phase 3 trial for HIV infections. It remains investigational and has not been reported as approved.

What clinical trials is stavudine, lamivudine, efavirenz in?

Stavudine, lamivudine, and efavirenz was studied in one completed Phase 3 clinical trial, NCT00135369. The trial enrolled 300 participants with HIV infections in the United States and Puerto Rico. It evaluated switching from a twice-daily or more frequent HAART regimen to a once-daily regimen.

Is stavudine, lamivudine, efavirenz the same as a once-daily HAART regimen?

Stavudine, lamivudine, and efavirenz was studied as a once-daily regimen in the clinical trial NCT00135369. The trial evaluated switching HIV-1 infected subjects from a HAART regimen dosed twice daily or more frequently to this once-daily combination.