Study of Once Daily Elvucitabine Versus Lamivudine in Subjects With a Documented M184V Mutation
Status:
Completed
Trial end date:
2007-10-01
Target enrollment:
Participant gender:
Summary
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.