A Long Term, Safety Study of Apricitabine in HIV-infected Subjects

NCT ID: NCT00367952

Last Updated: 2011-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2010-01-31

Brief Summary

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The study will examine how safe and effective apricitabine is when given long term (as ongoing treatment) to HIV patients who have already completed the AVX-201 trial

Detailed Description

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An ongoing study (AVX-201) is examining the safety and efficacy of apricitabine compared to 3TC in HIV patients who are failing therapy containing 3TC and have the presence of the M184V mutation in reverse transcriptase. This extension study (AVX-201E) is available to patients who complete the AVX-201 protocol.

Patients will continue to receive apricitabine open label for a further 96 weeks (making a total of 144 weeks from starting AVX-201) in addition to an optimised background. Safety markers and efficacy markers will be followed.

Conditions

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HIV Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ATC 800mg BID

800mg ATC BID

Group Type EXPERIMENTAL

apricitabine

Intervention Type DRUG

800mg apricitabine twice daily orally for 96 weeks

Interventions

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apricitabine

800mg apricitabine twice daily orally for 96 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Completed AVX-201 protocol, Plasma HIV RNA \<5000 copies/ml, CD4 cells \>50

Exclusion Criteria

* Pregnant or breastfeeding females, withdrawal from AVX-201
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Avexa

INDUSTRY

Sponsor Role lead

Responsible Party

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Avexa

Principal Investigators

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Susan W Cox, Ph D

Role: STUDY_DIRECTOR

Avexa

Locations

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Avexa (co-ordinating sites in Australia and Argentina)

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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AVX-201E

Identifier Type: -

Identifier Source: org_study_id

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