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zidovudine and lamivudine

Phase 3

HIV Infections | Small molecule | Infectious Disease |Gilead Sciences, Inc.|Last Updated: Jul 4, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment220

FDA Designations

No designations recorded

Clinical trial landscape

zidovudine and lamivudine · 1 trial · 1 indication

Phase 3 1
NCT00323544SWEET: Once Daily Truvada Versus Twice Daily Combivir for the Treatment of HIV InfectionHIV Infections
COMPLETED220 Analytics
PHASE3COMPLETED
SWEET: Once Daily Truvada Versus Twice Daily Combivir for the Treatment of HIV Infection
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary endpoint for the study is a change from baseline in absolute haemoglobin at Week 24.

Secondary Endpoints

The secondary endpoints in this study include: Change from baseline in absolute haemoglobin at Week 48
Lipids profile: change from baseline in total cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL), TC/HDL, and triglyceride (TG)
Quality of life (QoL)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
zidovudine and lamivudine (Combivir®)DRUG -
emtricitabine and tenofovir DFDRUG -
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Eligibility Criteria

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

Inclusion Criteria: 1. Patients of either sex aged \> 18 years. 2. HIV positive. 3. Stable antiretroviral therapy consisting of efavirenz (EFV) given with Combivir® or zidovudine (AZT) + lamivudine (3TC) for at least 6 months. 4. Patients with viral loads \< 50 copies/ml on last 2 consecutive tests...

Countries:United Kingdom
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Frequently asked questions about zidovudine and lamivudine

What is zidovudine and lamivudine used for in HIV Infections?

Zidovudine and lamivudine is a combination of two small molecule antiretroviral drugs used for the treatment of HIV Infections. It is being developed by Gilead Sciences, Inc. (NASDAQ: GILD) and is currently in Phase 3 clinical development. The drug is intended for adult patients, as the clinical trial enrolled individuals aged 18 years and older.

What does zidovudine and lamivudine target?

Zidovudine and lamivudine are nucleoside reverse transcriptase inhibitors (NRTIs) that target the HIV reverse transcriptase enzyme. By inhibiting this enzyme, the drugs interfere with the replication of the HIV virus, reducing viral load in patients with HIV Infections. This mechanism is the basis for their use in antiretroviral therapy.

Who makes zidovudine and lamivudine?

Zidovudine and lamivudine is developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol GILD. Gilead Sciences is conducting clinical trials to evaluate the safety and efficacy of this combination therapy for the treatment of HIV Infections.

What phase is zidovudine and lamivudine in?

Zidovudine and lamivudine is in Phase 3 clinical development for the treatment of HIV Infections. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trial, known as SWEET, has been completed, and the drug is being evaluated for its efficacy and safety in this late-stage study.

What clinical trials is zidovudine and lamivudine in?

Zidovudine and lamivudine has been studied in one Phase 3 clinical trial with the identifier NCT00323544, titled "SWEET: Once Daily Truvada Versus Twice Daily Combivir for the Treatment of HIV Infection." This completed trial enrolled 220 participants in the United Kingdom and was an uncontrolled, randomized study involving adult patients with HIV Infections.