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Stavudine

Phase 4FDA approved

AIDS | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Trials Updated: Sep 17, 2012

Stavudine development status

FDA approval on record Dec 31, 2002
Approval holderBristol Myers Squibb
ApplicationNDA021453
Highest phase Phase 4 run by Merck Sharp & Dohme LLC (NCT00002376)
Phase scored for BMYPhase 3
Registered trials 90 across 8 sponsors since Aug 2001

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLEDDMC
Total Trials6
Total Enrollment2,270

FDA Designations

No designations recorded

Stavudine clinical trials

Stavudine · 6 trials · 4 indications

Phase 3 6
NCT00197613The Adult Antiretroviral Treatment and Resistance Study (Tshepo)AIDS
COMPLETED650 Analytics
NCT00116298Rollover Study for Zerit (Stavudine) ER Studies (-096, -099)HIV Infections
COMPLETED900 Analytics
NCT00002429Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug RegimenHIV Infections
COMPLETED500 Analytics
NCT00002224Comparison of Two Anti-HIV Regimens That Include One of Two Forms of Didanosine (ddI)HIV Infections
COMPLETED120 Analytics
NCT00002246A Study to Evaluate the Use of Stavudine (d4T) to Treat AIDS Dementia ComplexAIDS Dementia Complex
COMPLETED20 Analytics
NCT00002371The Safety and Effectiveness of Lamivudine Plus Stavudine or Zidovudine in HIV-Infected Patients Who Have Taken ZidovudineHIV Infections
COMPLETED80 Analytics
PHASE3COMPLETED
The Adult Antiretroviral Treatment and Resistance Study (Tshepo)
AIDSUnlock trial analytics
PHASE3COMPLETED
Rollover Study for Zerit (Stavudine) ER Studies (-096, -099)
HIV InfectionsUnlock trial analytics
PHASE3COMPLETED
Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen
HIV InfectionsUnlock trial analytics
PHASE3COMPLETED
Comparison of Two Anti-HIV Regimens That Include One of Two Forms of Didanosine (ddI)
HIV InfectionsUnlock trial analytics
PHASE3COMPLETED
A Study to Evaluate the Use of Stavudine (d4T) to Treat AIDS Dementia Complex
AIDS Dementia ComplexUnlock trial analytics
PHASE3COMPLETED
The Safety and Effectiveness of Lamivudine Plus Stavudine or Zidovudine in HIV-Infected Patients Who Have Taken Zidovudine
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Time to Virological failure, time to grade 3 or higher toxicity.
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

Time to drug resistance, rates of point mutations at virological failure, adherence to study medication.
Efficacy: Changes in CD4 cell counts
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL

Interventions

NameTypeDescription
(A) zidovudine, lamivudine and nevirapineDRUG -
(B) zidovudine, lamivudine and efavirenzDRUG -
(C) zidovudine, didanosine, and nevirapineDRUG -
(D) zidovudine, didanosine, and efavirenzDRUG -
(E) stavudine, lamivudine, and nevirapineDRUG -
(F) stavudine, lamivudine and efavirenzDRUG -
Adherence Strategy Standard of Care (SOC)PROCEDURE -
Adherence Strategy Community-Based DOTPROCEDURE -
stavudine, efavirenz, lamivudineDRUG -
Lamivudine/ZidovudineDRUG -
Nelfinavir mesylateDRUG -
StavudineDRUG -
DidanosineDRUG -
Indinavir sulfateDRUG -
LamivudineDRUG -
ZidovudineDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria:(1) HIV infection indicated by (a) positive ELISA in two separate blood samples, the second no more than eight weeks prior to randomization), (b) CD4 cell count of less than 200 cells/ml OR CD4 cell count between 201-350 with plasma HIV-1 RNA level of greater than 55,000 copies/ml...

Countries:BotswanaUnited StatesArgentinaBelgiumBrazilCanadaFranceIsraelItalyMexicoPortugalPuerto RicoRussiaSingaporeSouth AfricaSpainThailandAustraliaUnited Kingdom
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Frequently asked questions about Stavudine

What is stavudine used for?

Stavudine is used to treat HIV infection and AIDS, including AIDS dementia complex. It is a small molecule antiretroviral studied in adult patients with HIV Infections and AIDS. Bristol-Myers Squibb Company developed it under the brand name Zerit, and it has been evaluated both as a single agent and in combination regimens.

Who makes stavudine?

Stavudine is developed and manufactured by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company ran the clinical development program for stavudine, including the extended-release Zerit studies and the rollover study for patients completing earlier trials.

What phase is stavudine in?

Stavudine reached Phase 3 clinical development. Four Phase 3 trials are recorded, all of them completed, with no active trials currently listed. The studies together enrolled about 1,600 participants. The program included randomized designs, and the trials were conducted across the United States, Canada, Botswana, and multiple European, Asian, African, and Latin American countries.

What clinical trials is stavudine in?

Stavudine was studied in four completed Phase 3 trials: NCT00197613, the Adult Antiretroviral Treatment and Resistance Study in Botswana; NCT00116298, a rollover study for Zerit extended-release trials; NCT00002429, comparing a regimen including coated didanosine; and NCT00002371, testing lamivudine plus stavudine or zidovudine in patients who had taken zidovudine.

Is stavudine the same as efavirenz or lamivudine?

No. Stavudine is a distinct drug, though it is often studied and used in combination with efavirenz, lamivudine, and nevirapine. Combination regimens pairing stavudine with lamivudine and nevirapine, or with efavirenz, appear in the clinical literature and trial records, but these are separate antiretroviral agents, not alternative names for stavudine.

What is stavudine also known as?

Stavudine is also known by the brand name Zerit, and it is frequently referenced in combination regimens such as stavudine, lamivudine, and nevirapine, or stavudine with efavirenz. Those combination labels describe multi-drug regimens rather than separate names for stavudine itself.