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AVX754 (a New Nucleoside Reverse Transcriptase Inhibitor [NRTI]) to Treat Drug-resistant HIV

NCT ID: NCT00126880

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

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2008-01-31

Brief Summary

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The study will measure how safe and effective AVX754 (a new drug for the treatment of HIV) is in treating HIV-1 infected people who have failed treatment with lamivudine.

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Detailed Description

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Lamivudine or emtricitabine are commonly used in combination with other drugs for first-line treatment of HIV infection. Although effective initially, many people later on develop resistance to some or all of the drugs (including lamivudine) leading to virological failure. Resistance is associated with characteristic mutations, which for lamivudine is the M184V mutation. A change to new, active drugs must take place when patients fail their current regime, to regain control of the virus. Although there are other types of drugs available for second line treatment, there is currently no fully active, well tolerated cytidine analogue that can replace lamivudine in a second-line regimen when patients fail first line treatment. This study will measure the efficacy and safety of AVX754 (a novel cytidine analogue with activity against HIV resistant to other nucleosides) as part of a new regimen to treat patients who have failed treatment containing lamivudine, compared to the best alternative new regimen which continues to include lamivudine.

Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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600mg BID ATC

600mg BID ATC

Group Type EXPERIMENTAL

AVX754

Intervention Type DRUG

apricitabine, 600mg BID or 800mg BID

800mg BID ATC

800mg BID ATC

Group Type EXPERIMENTAL

AVX754

Intervention Type DRUG

apricitabine, 600mg BID or 800mg BID

150mg BID 3TC

150mg BID 3TC

Group Type ACTIVE_COMPARATOR

3TC

Intervention Type DRUG

3TC, 150mg BID

Interventions

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AVX754

apricitabine, 600mg BID or 800mg BID

Intervention Type DRUG

3TC

3TC, 150mg BID

Intervention Type DRUG

Other Intervention Names

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apricitabine lamivudine

Eligibility Criteria

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Inclusion Criteria

* HIV-1 infected
* M184V mutation in reverse transcriptase
* Currently taking lamivudine
* Viral load \>2000 copies/ml

Exclusion Criteria

* Hepatitis B surface antigen positive
* Pregnant or breastfeeding females
* Hepatitis C RNA positive and requiring treatment
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-201

Identifier Type: -

Identifier Source: org_study_id

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