A Long Term Safety Study of Apricitabine in HIV-infected Patients
NCT00686270 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2011-06-23
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.
Conditions
- HIV Infections
Interventions
- DRUG
-
apricitabine
Initially 1200mg apricitabine twice daily orally. Following the determination of the optimum dose (800mg or 1200mg twice daily) in the pre-ceeding study AVX-301,patients may be switched to the optimum dose,if required.
Sponsors & Collaborators
-
Avexa
lead INDUSTRY
Principal Investigators
-
Mike Saag, Professor · UAB Centre for AIDS Research, Birmingham, Alabama, 35294-2050, USA
-
Susan W Cox, PhD · Avexa Ltd
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-05-31
- Primary Completion
- 2012-05-31
- Completion
- 2012-05-31
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