Overview

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

Status:
Withdrawn

Trial end date:
2012-05-01

Target enrollment:
0

Participant gender:
All

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-302; or (b)met the criteria for virological failure/lack of response, and consequently wish to withdraw early from studies AVX-301 or AVX-302.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Avexa

Criteria

Inclusion Criteria:

- 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 Criteria:

- 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