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Lamivudine/Zidovudine

Phase 3

HIV Infections | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: May 4, 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment500

FDA Designations

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Clinical trial landscape

Lamivudine/Zidovudine · 1 trial · 1 indication

Phase 3 1
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
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

Study Design & Arms

ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Lamivudine/ZidovudineDRUG -
Nelfinavir mesylateDRUG -
StavudineDRUG -
DidanosineDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion Criteria Patients may be eligible for this study if they: * Are HIV-positive. * Have a viral load of at least 2,000 copies/ml and a CD4 count of at least 200 cells/mm3. * Are at least 18 years old. * Agree to practice sexual abstinence or to use effective barrier methods of birth control...

Countries:United StatesCanada
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Frequently asked questions about Lamivudine/Zidovudine

What is Lamivudine/Zidovudine used for in HIV Infections?

Lamivudine/Zidovudine is a fixed-dose combination of two antiretroviral drugs used for the treatment of HIV Infections. It is being developed by Bristol-Myers Squibb Company and is currently in Phase 3 clinical development. The drug is a small molecule intended to suppress HIV replication and improve patient outcomes.

What does Lamivudine/Zidovudine target?

Lamivudine/Zidovudine targets HIV by combining two nucleoside reverse transcriptase inhibitors. Lamivudine and zidovudine both inhibit the HIV reverse transcriptase enzyme, which is essential for viral replication. By blocking this enzyme, the combination helps reduce the viral load in patients with HIV Infections.

Who makes Lamivudine/Zidovudine?

Lamivudine/Zidovudine is developed by Bristol-Myers Squibb Company, a global biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the safety and efficacy of this combination therapy for HIV Infections.

What phase is Lamivudine/Zidovudine in?

Lamivudine/Zidovudine is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trial, NCT00002429, has been completed, and the results will inform potential regulatory submissions for the treatment of HIV Infections.

What clinical trials is Lamivudine/Zidovudine in?

Lamivudine/Zidovudine has one completed Phase 3 clinical trial, NCT00002429, titled 'Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen.' The trial enrolled 500 participants with HIV Infections in the United States and Canada.

Is Lamivudine/Zidovudine the same as Combivir?

Lamivudine/Zidovudine is a combination of lamivudine and zidovudine, which are also marketed under the brand name Combivir. However, the specific formulation being studied by Bristol-Myers Squibb in the Phase 3 trial may differ from the commercially available product. The trial evaluates this combination as part of an investigational regimen.