Status:

TERMINATED

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

Lead Sponsor:

Avexa

Conditions:

HIV Infections

Eligibility:

All Genders

18+ years

Phase:

PHASE2

PHASE3

Brief 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...

Detailed Description

ATC has potent antiviral activity both in vitro (against wild-type HIV-1 and HIV-1 with mutations in reverse transcriptase that confer resistance to NRTIs), and in clinical studies in both treatment-n...

Eligibility Criteria

Inclusion

  • HIV-1 positive with M184V/I mutation in reverse transcriptase;
  • 18 years of age or older;
  • Currently taking lamivudine (3TC) or emtricitabine (FTC)

Exclusion

  • Female patients who are pregnant or breastfeeding;
  • Current hepatitis B virus (HBV) infection;
  • Current treatment for hepatitis C virus infection;
  • Renal function not adequate

Key Trial Info

Start Date :

February 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2010

Estimated Enrollment :

239 Patients enrolled

Trial Details

Trial ID

NCT00612898

Start Date

February 1 2008

End Date

January 1 2010

Last Update

January 23 2012

Active Locations (100)

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Page 1 of 25 (100 locations)

1

UAB, 845 19th St South, South Beville Biomedical Research Building

Birmingham, Alabama, United States, 35294-2170

2

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294-2170

3

Southwest Center for HIV/AIDS

Phoenix, Arizona, United States, 85006

4

Living Hope Clinical Foundation, Inc

Long Beach, California, United States, 90813