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stavudine, efavirenz, lamivudine

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

UNCONTROLLED
Total Trials1
Total Enrollment900

FDA Designations

No designations recorded

Clinical trial landscape

stavudine, efavirenz, lamivudine · 1 trial · 2 indications

Phase 3 1
NCT00116298Rollover Study for Zerit (Stavudine) ER Studies (-096, -099)HIV Infections
COMPLETED900 Analytics
PHASE3COMPLETED
Rollover Study for Zerit (Stavudine) ER Studies (-096, -099)
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety: Frequency and severity of AEs, and treatment discontinuations for AEs; population trends for triglycerides and cholesterol. Primary efficacy outcome: proportion of subjects with HIVRNA <400, <50, and change in viral load over the study period

Secondary Endpoints

Efficacy: Changes in CD4 cell counts
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
stavudine, efavirenz, lamivudineDRUG -
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Eligibility Criteria

SexALL
Healthy VolunteersNo
Study Sites63

Inclusion Criteria: * Completed d4T studies AI455-096 or AI455-099 * Have demonstrated compliance with the study medication and treatment visits * Provide written informed consent * Agree to use a barrier method of birth control (such as condoms) during the study * Have a negative pregnancy test wi...

Countries:United StatesArgentinaBelgiumBrazilCanadaFranceIsraelItalyMexicoPortugalPuerto RicoRussiaSingaporeSouth AfricaSpainThailand
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Frequently asked questions about stavudine, efavirenz, lamivudine

What is Stavudine used for?

Stavudine is an investigational small molecule being studied for the treatment of HIV Infections and AIDS Dementia Complex. It is being developed by Bristol-Myers Squibb Company (BMY) and is currently in Phase 3 clinical development. Stavudine is not approved and remains under investigation for these indications.

What does Stavudine target?

Stavudine is a small molecule being studied for HIV Infections and AIDS Dementia Complex. Its molecular target has not been disclosed in the available information, so its specific mechanism of action is not described here. The drug is in Phase 3 clinical trials for these infectious disease indications.

Who makes Stavudine?

Stavudine is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting Phase 3 clinical trials for Stavudine in HIV Infections and AIDS Dementia Complex. Stavudine is an investigational small molecule and has not been approved for these uses.

What phase is Stavudine in?

Stavudine is in Phase 3 clinical development. It is being studied for HIV Infections and AIDS Dementia Complex, with two completed Phase 3 trials. Stavudine is investigational and not yet approved, as it remains in clinical trials for these indications.

What clinical trials is Stavudine in?

Stavudine has two completed Phase 3 trials: NCT00002246, which evaluated stavudine (d4T) for AIDS Dementia Complex with 20 participants in the US, Australia, and UK, and NCT00116298, a rollover study for Zerit (stavudine) ER with 900 participants across multiple countries. Both trials are completed.

Is Stavudine the same as Zerit?

Stavudine is also known as Zerit, as referenced in the clinical trial NCT00116298, which is titled 'Rollover Study for Zerit (Stavudine) ER Studies'. This indicates that Zerit is a brand name for stavudine. Stavudine is being developed by Bristol-Myers Squibb Company for HIV Infections and AIDS Dementia Complex.