Status:

WITHDRAWN

A Long Term Safety Study of Apricitabine in HIV-infected Patients

Lead Sponsor:

Avexa

Conditions:

HIV Infections

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

This study will examine the long term safety of apricitabine in HIV-1 infected patients from studies AVX-301 or AVX-302. Eligible patients are those who have either (a)completed studies AVX-301 or AVX...

Detailed Description

The clinical study AVX-301 studies the efficacy and safety of 800mg and 1200mg BID ATC in combination with an optimized background in patients who are HIV-1 infected and have failed treatment with emt...

Eligibility Criteria

Inclusion

  • Patients who complete studies AVX-301 or AVX-302 or :Patients who meet the criteria for virologic failure/lack of response in study AVX-301 or AVX-302
  • 18 years of age, or older
  • Male, or non-pregnant, non-breastfeeding female patients, who agree to comply with the applicable contraceptive requirements of the protocol.

Exclusion

  • Prior withdrawal from AVX-301 or AVX-302
  • Current acute or chronic hepatitis B virus infection
  • Current treatment for hepatitis C virus infection
  • Renal Function not adequate

Key Trial Info

Start Date :

May 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2012

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00686270

Start Date

May 1 2008

End Date

May 1 2012

Last Update

June 23 2011

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