Safety Study of Elvucitabine in HIV-1 Subjects

14-Day Randomized Double-Blind Comparative Viral Kinetic Study of Elvucitabine Versus Lamivudine Once Daily to HIv-1 Subjects With M184V

The purpose of this 28 day study is to assess the viral kinetics and safety of elvucitabine.

This is a 14 day on treat/14 day off treatment randomized, double blind viral kinetic study of elvucitabine versus lamivudine administered once daily to HIV infected subjects with a documented M184V variant.

Inclusion Criteria:

• HIV infected, clinically stable, adults
• HIVRNA 5000 -150,000, CD4 100
• Genotypically documented M184V variant
• Receiving stable ART.

Exclusion Criteria:

• Hep B
• HIV-1 genotype for 4 protease inhibitors
• HIV-1 genotype positive for 2 NNRTI mutations
• Previous therapy with system myelosuppressive potential within 3 months of study start
• Use of Epogen or Neupogen
• History of cirrhosis
• Alcohol or drug dependence
• Inability to tolerate oral medication
• Women who are pregnant or breast feeding