A Long Term Safety Study of Apricitabine in HIV-infected Patients
June 22, 2011 updated by: Avexa
A Phase 3, Open Label 96-week Extension Study of the Safety of Apricitabine in Treatment-experienced HIV-1 Infected Patients Who Have Completed Protocol AVX-301 or AVX-302 or Who Have Met the Criteria for Open-label Access to ATC Because of Virological Failure/Lack of Response
This study will examine the long term safety of apricitabine in HIV-1 infected patients from studies AVX-301 or AVX-302.
Eligible patients are those who have either (a)completed studies AVX-301 or AVX-302; or (b)met the criteria for virological failure/lack of response, and consequently wish to withdraw early from studies AVX-301 or AVX-302.
Study Overview
Detailed Description
The clinical study AVX-301 studies the efficacy and safety of 800mg and 1200mg BID ATC in combination with an optimized background in patients who are HIV-1 infected and have failed treatment with emtricitabine or lamivudine and have confirmed M184V/I mutation.
Patients who do not achieve at least a 0.5 log10 copies/mL decrease in plasma HIV RNA by Week 16, or who experience a >1.0 log10 copies/mL increase (confirmed on two separate occasions at least one week apart) in plasma HIV RNA from nadir at or after Week 16, are eligible for screening for entry into this study.
In addition, patients who complete study AVX-301 are also eligible for screening.
The clinical study AVX-302 is similar and studies the efficacy and safety of a single dose of ATC (determined in AVX-301).
Patients in AVX-302 who experience virologic failure or lack of virologic response will similarly be eligible for screening for entry into this study.
In addition, patients who complete study AVX-302 are also eligible for screening.
This is a phase 3, open-label, multi-center study of up to 96 weeks duration.
Patients will receive for up to 96 weeks open-label ATC, initially at a dose of 1200mg orally BID.
Following selection of the optimum ATC dose in protocol AVX-301 and termination of one of the two ATC doses (800mg or 1200mg orally BID) in protocol AVX-301, patients in this protocol will be transferred to the optimum dose, if required.
The total number of patients expected to be enrolled in studies AVX-301 and AVX-302 is approximately 1866 in total.Patients will receive ATC orally in combination with their existing ART.
Background antiretroviral therapy (ART) may be revised at any time during the study at the discretion of the investigator but must not include lamivudine, emtricitabine, zalcitabine or any other deoxycytidine analogue NRTI.
The study will examine the safety and tolerability of long term treatment with apricitabine in combination with other ART.
Study Type
Interventional
Phase
- Phase 3
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 and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients who complete studies AVX-301 or AVX-302 or :Patients who meet the criteria for virologic failure/lack of response in study AVX-301 or AVX-302
- 18 years of age, or older
- Male, or non-pregnant, non-breastfeeding female patients, who agree to comply with the applicable contraceptive requirements of the protocol.
Exclusion Criteria:
- Prior withdrawal from AVX-301 or AVX-302
- Current acute or chronic hepatitis B virus infection
- Current treatment for hepatitis C virus infection
- Renal Function not adequate
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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 1
apricitabine
|
Initially 1200mg apricitabine twice daily orally.
Following the determination of the optimum dose (800mg or 1200mg twice daily) in the pre-ceeding study AVX-301,patients may be switched to the optimum dose,if required.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The number, type and severity of SAEs occuring during the study
Time Frame: Week 96
|
Week 96
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mike Saag, Professor, UAB Centre for AIDS Research, Birmingham, Alabama, 35294-2050, USA
- Study Director: Susan W Cox, PhD, Avexa Ltd
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
May 1, 2008
Primary Completion (ANTICIPATED)
May 1, 2012
Study Completion (ANTICIPATED)
May 1, 2012
Study Registration Dates
First Submitted
May 27, 2008
First Submitted That Met QC Criteria
May 28, 2008
First Posted (ESTIMATE)
May 29, 2008
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-303
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.