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zidovudine, lamivudine and nevirapine

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment650

FDA Designations

No designations recorded

Clinical trial landscape

zidovudine, lamivudine and nevirapine · 1 trial · 2 indications

Phase 3 1
NCT00197613The Adult Antiretroviral Treatment and Resistance Study (Tshepo)AIDS
COMPLETED650 Analytics
PHASE3COMPLETED
The Adult Antiretroviral Treatment and Resistance Study (Tshepo)
AIDSUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

Time to drug resistance, rates of point mutations at virological failure, adherence to study medication.
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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 -
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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:Botswana
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Frequently asked questions about zidovudine, lamivudine and nevirapine

What is zidovudine, lamivudine and nevirapine used for?

Zidovudine, lamivudine and nevirapine is a combination of three antiretroviral drugs used for the treatment of AIDS and HIV infection. It is being developed by Bristol-Myers Squibb Company (BMY) as a small molecule therapy for infectious disease.

What does zidovudine, lamivudine and nevirapine target?

Zidovudine, lamivudine and nevirapine targets HIV reverse transcriptase. Zidovudine and lamivudine are nucleoside reverse transcriptase inhibitors, while nevirapine is a non-nucleoside reverse transcriptase inhibitor. Together they block viral replication by inhibiting this enzyme.

Who makes zidovudine, lamivudine and nevirapine?

Bristol-Myers Squibb Company (ticker: BMY) is developing zidovudine, lamivudine and nevirapine. The drug is a combination of three small molecule antiretroviral agents intended for the treatment of AIDS and HIV infection.

What phase is zidovudine, lamivudine and nevirapine in?

Zidovudine, lamivudine and nevirapine is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed, with no active trials currently ongoing.

What clinical trials is zidovudine, lamivudine and nevirapine in?

Zidovudine, lamivudine and nevirapine was studied in a Phase 3 trial with NCT number NCT00197613, titled "The Adult Antiretroviral Treatment and Resistance Study (Tshepo)". This completed trial enrolled 650 participants with AIDS or HIV infection in Botswana, with a minimum age of 18 years.