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

Primary Purpose

HIV Infection

Status

Completed

Phase

Phase 2

Locations

Australia

Study Type

Interventional

Intervention

apricitabine

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring HIV, apricitabine, drug resistance, reverse transcriptase, lamivudine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Avexa (co-ordinating sites in Australia and Argentina)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ATC 800mg BID

Arm Description

800mg ATC BID

Outcomes

Primary Outcome Measures

Time to virological failure (DHSS definition)

incidence of AEs and laboratory abnormalities

time to withdrawal due to AEs

Secondary Outcome Measures

Change from baseline HIV RNA

Proportion of subjects with plasma HIV RNA <400 and <50 copies/ml

Change from baseline and change in ratio of CD4+ and CD8+ counts

Full Information

NCT ID

NCT00367952

First Posted

August 22, 2006

Last Updated

June 22, 2011

Sponsor

Avexa

1. Study Identification

Unique Protocol Identification Number

NCT00367952

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

August 2006 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Avexa

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infection

Keywords

HIV, apricitabine, drug resistance, reverse transcriptase, lamivudine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ATC 800mg BID

Arm Type

Experimental

Arm Description

800mg ATC BID

Intervention Type

Drug

Intervention Name(s)

apricitabine

Intervention Description

800mg apricitabine twice daily orally for 96 weeks

Primary Outcome Measure Information:

Title

Time to virological failure (DHSS definition)

Time Frame

week 144

Title

incidence of AEs and laboratory abnormalities

Time Frame

Week 144

Title

time to withdrawal due to AEs

Time Frame

Week 144

Secondary Outcome Measure Information:

Title

Change from baseline HIV RNA

Time Frame

weeks 72, 96, 120, and 144

Title

Proportion of subjects with plasma HIV RNA <400 and <50 copies/ml

Time Frame

at weeks 72, 96, 120, and 144

Title

Change from baseline and change in ratio of CD4+ and CD8+ counts

Time Frame

at weeks 72, 96, 120, and 144

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susan W Cox, Ph D

Organizational Affiliation

Avexa

Official's Role

Study Director

Facility Information:

Facility Name

Avexa (co-ordinating sites in Australia and Argentina)

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3121

Country

Australia

12. IPD Sharing Statement

Learn more about this trial

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

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