Elvucitabine/Efavirenz/Tenofovir vs. Lamivudine/Efavirenz/Tenofovir in HIV-1 Infected, Treatment Naive Subjects
Status:
Completed
Trial end date:
2009-04-01
Target enrollment:
Participant gender:
Summary
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.