Study of Once Daily Elvucitabine Versus Lamivudine in Subjects With a Documented M184V Mutation

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Achillion Pharmaceuticals; Alexion Pharmaceuticals
• Treatments: Dexelvucitabine; Lamivudine

Criteria

Inclusion Criteria:

• Clinically stable HIV-1 infected patients

• Ages > 18 and < 65 years

• Documented M184V mutation

• CD4 cell count > 100 cells/mL

• Plasma HIV-1 RNA levels > 5000 and < 150,000 copies/mL

• Currently receiving lamivudine or emtricitabine

• Other hematologic and metabolic parameters must be met.

• Provide written informed consent

• Other inclusion criteria apply.

Exclusion Criteria:

• Hepatitis B antigen positive

• HIV-1 genotype positive for more than or equal to 4 protease mutations

• HIV-1 genotype positive for more than or equal to 2 non-nucleoside reverse transcriptase inhibitor (NNRTI) mutations

• Previous therapy with cytotoxic or myelosuppressive drugs in the past 3 months

• Evidence or history of cirrhosis

• Women who are pregnant or breast feeding

• Other exclusion criteria apply.