Identification of Susceptibility to Abacavir Hypersensitivity Reaction (HSR) in HIV-1 Infected Patients in Sydney, Australia and Development of Mechanisms for Risk Reduction

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12607000030471

Acronym

Abacavir Hypersensitivity Study

Enrollment

500

Registered

2007-01-11

Start date

2007-01-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is being conducted in order to determine the proportion of HIV-1 patients attending Holdsworth House Medical Practice that may be susceptible to abacavir hypersensitivity reaction (HSR), which is associated with a genetic marker HLA-B*5701. Abacavir is a drug used in combination with other antiviral drugs, which is helpful in treating HIV infection. Abacavir is generally well tolerated, but 5-8% of patients develop an allergic reaction to the drug and the allergic reaction is much more common in those patients who have the genetic marker HLA-B*5701. Abacavir HSR is an allergic reaction characterised by respiratory and gastrointestinal symptoms that may be life threatening if abacavir dosing continues. Thus avoiding the use of abacavir in patients carrying this genetic marker will reduce the likelihood of developing a potentially serious allergic reaction. The study also aims to set up a model for a Registry where patient HLA-B*5701 results can be entered and made available to doctors who are licensed to prescribe HIV therapies in Australia via a secure password protected system. Ideally the Registry will be web-based, but if this is not feasible, it will be paper-based and managed by a recognised independent body already involved in the HIV field.

Interventions

Testing • Strategy: sequence-specific primer (SSP) - amplify only intron 2 and exon 3 of a limited subset of HLA types • 5’ primer in intron 2 hybridises to all B*57 and B*58 sequences but not others • 3’ primer is a universal HLA-B primer • If Polymerase chain reaction (PCR) negative: then not HLA-B*5701 • If PCR positive: then possibly HLA-B*57 – sequence PCR amplicon to distinguish HLA-B*57from HLA-B*58 – Use Single Nucleotide Polymorphism (SNPs) to determine HLA-B*5701 (or 06 or 08) or not – Can distinguish these alleles from other HLA-B*57alleles and from HLA-B*58 Condition being observed 1. Prevalence of HLA-B*5701 in abacavir-naïve HIV-1 participants 2. Prevalence of HLA-B*5701 in abacavir-experienced participants who has also had abacavir HSR Duration of the Trial January to June 2007 No. HLA-B*5701 is a specific DNA sequence present in a small percentage of the total population. This sequence is part of the immune system and is associated with hypersensitivity reaction when given the HIV drug treatment abacavir.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Documented HIV-1 infection. 2. Abacavir treatment naive or 3. Previous abacavir HSR. 4. Able to understand and willing to sign informed consent. 5. Able to return for discussion of B*5701 test results.

Exclusion criteria

1. Previous abacavir exposure with no diagnosis of abacavir HSR 2. Patients unable to submit a blood sample 3. Unable to understand English where translator not available.

Outcome results