HIV InfectionPhase 2NCT00367952
A Long Term, Safety Study of Apricitabine in HIV-infected Subjects
A Phase 2 study testing apricitabine in people with HIV Infection, run by Avexa at 1 site in Australia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infection
- What is being tested?
- apricitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2006to Jan 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completed AVX-201 protocol, Plasma HIV RNA <5000 copies/ml, CD4 cells >50
Who cannot join
- Pregnant or breastfeeding females, withdrawal from AVX-201
Trial locations and contacts
1 site in 1 country.
Australia1 site
Avexa (co-ordinating sites in Australia and Argentina)
Melbourne, Victoria, 3121
About this study
Official title: 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
Read the 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.
- Conditions
- HIV Infection
- Being tested
- apricitabine
- Keywords
- HIV, apricitabine, drug resistance, reverse transcriptase, lamivudine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apricitabineDrug
800mg apricitabine twice daily orally for 96 weeks
| Study group | Role | What they receive |
|---|---|---|
| ATC 800mg BID | Experimental | 800mg ATC BID Receives: Drug: apricitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to virological failure (DHSS definition)
Measured: week 144
incidence of AEs and laboratory abnormalities
Measured: Week 144
time to withdrawal due to AEs
Measured: Week 144
Secondary outcomes (3)
Change from baseline HIV RNA
Measured: weeks 72, 96, 120, and 144
Proportion of subjects with plasma HIV RNA <400 and <50 copies/ml
Measured: at weeks 72, 96, 120, and 144
Change from baseline and change in ratio of CD4+ and CD8+ counts
Measured: at weeks 72, 96, 120, and 144
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avexa
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Susan W Cox, Ph D, Study director, Avexa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367952
- Sponsor's protocol ID
- AVX-201E
- Status last verified
- Jun 2011
- First submitted
- 22 Aug 2006
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Long Term Safety Extension Study of Apricitabine in Treatment-experienced HIV-1 Infected Subjects
- ClinicalTrials.gov ID
- NCT00367952
- Acronym / sponsor ID
- AVX-201E
- Conditions
- HIV Infection
- Keywords
- HIV, apricitabine, drug resistance, reverse transcriptase, lamivudine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- AvexaIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 24 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATC 800mg BID | Experimental | Drug: apricitabine800mg ATC BID |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Completed AVX-201 protocol, Plasma HIV RNA <5000 copies/ml, CD4 cells >50
Key exclusion criteria (1 listed)
- Pregnant or breastfeeding females, withdrawal from AVX-201
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| apricitabine800mg apricitabine twice daily orally for 96 weeks | Drug | ATC 800mg BID |
Primary outcome
Time to virological failure (DHSS definition)
Time frame: week 144
incidence of AEs and laboratory abnormalities
Time frame: Week 144
time to withdrawal due to AEs
Time frame: Week 144
3 secondary outcomes
Change from baseline HIV RNA
Time frame: 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
Change from baseline and change in ratio of CD4+ and CD8+ counts
Time frame: at weeks 72, 96, 120, and 144
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan W Cox, Ph D study director
Avexa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing apricitabine in people with HIV Infection, run by Avexa at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to virological failure (DHSS definition) (time frame: week 144). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011.