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Generated: June 18, 2019

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CLINICAL TRIALS PROFILE FOR ELVUCITABINE

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Clinical Trials for Elvucitabine

Trial ID Title Status Sponsor Phase Summary
NCT00300573 Randomized, Double-Blind Study Comparing Dexelvucitabine (DFC) to Lamivudine (3TC) in Subjects With Resistance to NRTIs, PIs, and NNRTIs Terminated Incyte Corporation Phase 2 The study will compare the safety and efficacy of an investigation nucleoside analog reverse transcriptase inhibitor (NRTI), dexelvucitabine (DFC), to an approved NRTI, lamivudine (3TC) in HIV treatment-experienced patients who are resistant to 3 classes of antiretroviral therapies (NRTIs, PIs and NNRTIs). Patients meeting eligibility requirements will have a new 'optimized' background regimen (OBR) selected for them by their investigator based on prior ARV treatment history and the results of HIV genotype and phenotype tests performed during the screening period. In addition to treatment with the new OBR, patients will be randomized to receive treatment with either DFC or 3TC in a blinded fashion. There is a 50 percent chance a patient will receive DFC or 3TC. Treatment in the study may continue for up to 96 weeks. Patients with an inadequate response to therapy after 16 weeks will have the option to change their OBR and the option to switch to receive the other study medication (i.e., DFC to 3TC or 3TC to DFC).
NCT00312039 Study of Once Daily Elvucitabine Versus Lamivudine in Subjects With a Documented M184V Mutation Completed Achillion Pharmaceuticals Phase 1/Phase 2 HIV-1 infected patients receiving long-term therapy with lamivudine or emtricitabine (nucleoside reverse transcriptase inhibitors [NRTIs]) are at risk for the development of a mutation at position M184 on the HIV reverse transcriptase gene. This mutation confers resistance to both drugs (> 100 fold increase in IC50). In-vitro studies with elvucitabine have shown that HIV-1 isolates with the M184V mutation show only a 10-fold increase in IC50 as compared to wild type HIV-1. Achillion Pharmaceutical's intention is to demonstrate that 10 mg of elvucitabine, administered once per day for 14 days with continued background anti-HIV-1 medications, will demonstrate a fall in HIV-1 RNA plasma levels, as compared to baseline. The data from this study will guide dosing in future long-term studies in HIV-1 infected patients with the M184V mutation.
NCT00350272 Elvucitabine/Efavirenz/Tenofovir vs. Lamivudine/Efavirenz/Tenofovir in HIV-1 Infected, Treatment Naive Subjects Completed Achillion Pharmaceuticals Phase 2 Elvucitabine is a novel nucleoside analog that is being studied as a treatment for patients infected with HIV-1. This Phase II study will enroll 60 HIV-1 naive subjects to assess the efficacy and safety of elvucitabine compared to lamivudine in combination with tenofovir and efavirenz measured by changes in the patient's HIV-RNA level and CD4 cell count. The study treatment will be 12 weeks of blinded study medication followed by an additional 84 weeks of open label treatment if the patient's response to treatment meets certain endpoints. Also there will be assessment of the pharmacokinetics of elvucitabine during the study.
NCT00380159 Open-Label, 48 Week Extension Study of Elvucitabine in Combination With Background ART For Subjects Who Have Completed Study ACH443-014A Completed Achillion Pharmaceuticals Phase 2 To assess the safety of 48 weeks of treatment with 10 mg of elvucitabine in combination with background ART in subjects who completed protocol ACH443-014A and meet the inclusion and exclusion criteria.
NCT00405249 Safety Study of Elvucitabine in HIV-1 Subjects Completed Thomas Jefferson University Phase 2 The purpose of this 28 day study is to assess the viral kinetics and safety of elvucitabine.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Elvucitabine

Condition Name

Condition Name for
Intervention Trials
HIV Infections 5
Human Immunodeficiency Virus 1
HIV-1 Infection 1
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Condition MeSH

Condition MeSH for
Intervention Trials
HIV Infections 5
Acquired Immunodeficiency Syndrome 1
Immunologic Deficiency Syndromes 1
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Clinical Trial Locations for Elvucitabine

Trials by Country

Trials by Country for
Location Trials
United States 31
Puerto Rico 2
Germany 1
Dominican Republic 1
Spain 1
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Trials by US State

Trials by US State for
Location Trials
Florida 4
Texas 3
New York 3
Georgia 3
California 3
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Clinical Trial Progress for Elvucitabine

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 2 5
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 5
Terminated 1
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Clinical Trial Sponsors for Elvucitabine

Sponsor Name

Sponsor Name for
Sponsor Trials
Achillion Pharmaceuticals 4
Incyte Corporation 1
Orlando Immunology Center 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Other 6
Industry 5
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