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Report for Clinical Trial NCT00686270

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 3, Open Label 96-week Extension Study of the Safety of Apricitabine in Treatment-experienced HIV-1 Infected Patients Who Have Completed Protocol AVX-301 or AVX-302 or Who Have Met the Criteria for Open-label Access to ATC Because of Virological Failure/Lack of Response

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.

NCT00686270 HIV Infections
MeSH:Infection HIV Infections

1 Interventions

Name: apricitabine

Description: 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.
Type: Drug
Group Labels: 1


Primary Outcomes

Measure: The number, type and severity of SAEs occuring during the study

Time: Week 96

Purpose: Treatment

Allocation: N/A

Single Group Assignment

There is one SNP


1 M184V

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 HIV Infections Infection HIV Infections 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 emtricitabine or lamivudine and have confirmed M184V/I mutation. --- M184V ---

HPO Nodes