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
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infection focused on measuring HIV, apricitabine, drug resistance, reverse transcriptase, lamivudine
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
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
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
No
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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