Study of the Efficacy and Safety of Apricitabine, a New NRTI, to Treat Drug-resistant HIV Infection

• Status: Terminated
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Apricitabine is a new NRTI which is active against drug-resistant HIV. NRTIs are often included as part of patients' treatment, but many HIV-infected patients develop resistance to commonly used NRTIs such as lamivudine (3TC) and emtricitabine (FTC). This study will examine whether including apricitabine as part of patients' treatment is more effective than including lamivudine,when patients change treatment because of drug resistance.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Avexa
• Treatments: Lamivudine

Criteria

Inclusion Criteria:

• HIV-1 positive with M184V/I mutation in reverse transcriptase;

• 18 years of age or older;

• Currently taking lamivudine (3TC) or emtricitabine (FTC)

Exclusion Criteria:

• Female patients who are pregnant or breastfeeding;

• Current hepatitis B virus (HBV) infection;

• Current treatment for hepatitis C virus infection;

• Renal function not adequate