CLINICAL TRIALS PROFILE FOR ELVUCITABINE

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.
NCT00312039 ↗	Study of Once Daily Elvucitabine Versus Lamivudine in Subjects With a Documented M184V Mutation	Completed	Alexion 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.

Clinical Trial Conditions for Elvucitabine

Condition Name

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

Condition MeSH

Condition MeSH for
Intervention	Trials
HIV Infections	5
Acquired Immunodeficiency Syndrome	1
Infections	1
Immunologic Deficiency Syndromes	1

Clinical Trial Locations for Elvucitabine

Trials by Country

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

Trials by US State

Trials by US State for
Location	Trials
Florida	4
New York	3
Georgia	3
California	3
Texas	3

Clinical Trial Progress for Elvucitabine

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for Elvucitabine

Sponsor Name

Sponsor Name for
Sponsor	Trials
Achillion Pharmaceuticals	4
Alexion Pharmaceuticals	4
Saint Michael	1

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	9
Other	6