This trial is concluded. This means the trial has been completed. The results of the trial are summarised in the 'results' section of this page. You cannot enrol in this trial.
About this trial
This is an observational study looking at a particular genetic sequence sometimes found in the immune system which is directly associated with the risk of developing a hypersensitivity reaction (a severe, sometimes life-threatening reaction) to the HIV antiretroviralA medication or other substance which is active against retroviruses such as HIV. drug abacavir. The genetic sequence associated with this problem is known as HLA-*B5701 and it is present in a small percentage of the population. It is this percentage of people who are at risk of a severe reaction when they start abacavir, so it is not used in people who have this genetic trait.
In this study, patients are tested for the presence or absence of this genetic sequence, to help establish how common it is. The researchers then enter this information into a registry. The aim of this is to trial a way of recording this information, and having it available to medical practitioners who may need it, in a safe and secure way.
This model could then be used more generally by other doctors to develop systems so that the collection of this information may become more routinely used as part of standard HIV care.
This is an observational study, so there is no actual specific treatment entailed. People consenting to the study will be required to undertake two visits to the clinic, where they will be tested for the HLA-*B5701 sequence, and then return for their results. People testing positive will be advised they should never be treated with abacavir.
Background information
Abacavir hypersensitivity reaction, which typically occurs soon after the commencement of treatment, can be extremely dangerous. Symptoms can include rash, blisters, ulceration, and other severe immunological problems. It is thought that roughly three percent of people may experience this reaction. In a number of cases, people have died following extremely severe reactions.
People commencing a regimen including either Kivexa or Trizivir should note that abacavir is a component of both of these fixed-dose combinations. (Fixed-dose combinations are popular as they simplify the number of pills entailed in treatment.)
For the majority of people able to tolerate it, abacavir is widely regarded as a very useful HIV treatment. It has relatively few side effects and it works very well against HIV.
| Official title: | Identification of susceptibility to abacavir hypersensitivity reaction (HSR) in HIV-1 infected patients in Sydney, Australia and Development of Mechanisms for Risk Reduction |
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| What is this trial studying? | Side effect management |
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| Start date: | January 2007 This may be the proposed or expected start date for trials which have not yet started. |
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| Links to further information: | |
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| Can I access this treatment other than by enrolling in this trial? | HLA-*B5701 testing is available through some Australian laboratories. Availability varies between state to state. A hospital-based HIV specialist or your HIV s100 prescribing doctor can provide further advice.
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| Tags: | HLA-B*5701, hypersensitivity reactions |
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Who can enrol in this trial?
You may be eligible to participate in this trial if you meet the following criteria:
- At least 18 years old
- You have never taken abacavir OR you have taken it but experienced a hypersensitivity reaction
You
will not be eligible to participate in this trial if you meet any of the following criteria:
- You have previously taken abacavir and did not experience a hypersensitivity reaction
This is a summary of key inclusion and exclusion criteria for this trial. There may be other criteria which may exclude some people from participation in this trial. Some laboratory tests may also be required. Consult your doctor, or view the trial protocol or informed consent documentation to see the full range of exclusion and inclusion criteria.
Results:
See link above for abstract detailing outcomes
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