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

June 22, 2011 updated by: Avexa

An Open Label Long Term Safety Extension Study of Apricitabine in Treatment-experienced HIV-1 Infected Subjects

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3121
        • Avexa (co-ordinating sites in Australia and Argentina)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ATC 800mg BID
800mg ATC BID
Drug: apricitabine
800mg apricitabine twice daily orally for 96 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to virological failure (DHSS definition)
Time Frame: week 144
week 144
incidence of AEs and laboratory abnormalities
Time Frame: Week 144
Week 144
time to withdrawal due to AEs
Time Frame: Week 144
Week 144

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline HIV RNA
Time Frame: weeks 72, 96, 120, and 144
weeks 72, 96, 120, and 144
Proportion of subjects with plasma HIV RNA <400 and <50 copies/ml
Time Frame: at weeks 72, 96, 120, and 144
at weeks 72, 96, 120, and 144
Change from baseline and change in ratio of CD4+ and CD8+ counts
Time Frame: at weeks 72, 96, 120, and 144
at weeks 72, 96, 120, and 144

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avexa

Investigators

  • Study Director: Susan W Cox, Ph D, Avexa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

August 22, 2006

First Submitted That Met QC Criteria

August 23, 2006

First Posted (Estimate)

August 24, 2006

Study Record Updates

Last Update Posted (Estimate)

June 23, 2011

Last Update Submitted That Met QC Criteria

June 22, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVX-201E

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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