A clinical trial is examining whether it is possible to limit damage to the immune system by treating people soon after they are infected with HIV with a short course of antiretroviral drugs.
For most people in high-income countries, HIV is considered a chronic illness that can be managed with medication. But the virus still causes extensive damage to the immune system, and treatment with antiretrovirals is a lifelong commitment. Once the course of treatment is started, usually within three to five years of infection, it needs to be strictly followed and taken for life.
The clinical trial study, known as SPARTAC (Short Pulse Anti Retroviral Therapy at HIV Seroconversion), is following 371 individuals, recruited in eight countries across four continents. The trial, which began recruiting at the end of 2004, is due to be completed this month, and the results will be announced in 2011. If positive, the findings could have a major impact on how HIV is managed worldwide.
In the first few months after infection, the immune system recognises the infection and produces antibodies in an attempt to eliminate the virus. Unless tested, most people will be unaware that they have been infected at this stage. However, the immune system never successfully clears HIV. Instead, the virus hides away, slowly weakening the body’s defences and destroying CD4 cells, which play a key part in the infected person’s immune response.
When the number of remaining CD4 cells falls below a certain level – 350 cells per cubic millimetre – an individual needs to begin treatment with antiretroviral drugs. These drugs prevent the virus from doing further damage to the immune system. Without antiretrovirals, the immune system becomes so compromised that the individual is at high risk of developing life-threatening infections.
Several small studies have suggested that treatment during the first few months of infection could potentially alter the rate of immune damage and so delay the need to commence lifelong treatment. This hypothesis has not yet been tested in a large enough study to definitively determine whether it is correct.
Researchers at Imperial College London, together with colleagues from the Medical Research Council Clinical Trials Unit and the University of Oxford, have been conducting the SPARTAC trial to test this hypothesis. The trial has been conducted in collaboration with investigators across the UK, the Republic of Ireland, Uganda, South Africa, Australia, Brazil, Italy and Spain.
“Antiretroviral drugs are effective at treating HIV, but can have unpleasant side-effects, and once started must be taken for life,” explains Dr Sarah Fidler, who is leading the Imperial College London research trial. “From the patient’s perspective, the longer we can postpone lifelong treatment, the better. Plus, it could also mean a more cost-effective treatment over a person’s lifetime so it would be a win-win situation.”
If the findings prove positive, it will be crucial for doctors to treat the disease at this early stage, even if only for a short time. This means, however, that people would need to be tested and diagnosed within weeks of infection. Dr Fidler believes that this approach will strengthen the call for more widespread testing for HIV – but even if the trial shows that a short course of antiretrovirals has no effect, she says, routine testing would still be beneficial.
“Around one in four infected people in the UK do not know they are infected, and will seek care and start treatment at a later time than that recommend by the treatment guidelines. Routine testing, for example when a person is admitted to hospital, would help us diagnose the disease earlier, offering better treatment options.
“What’s also particularly important about diagnosing people at this early stage when their viral load is at its highest making them highly infectious, is that it gives the infected individual a chance to modify their sexual behaviour to help prevent the spread of HIV to others.”
The trial has been undertaken in both high-income and resource-poor settings and across the key different risk groups: heterosexuals, men who have sex with other men, and African women. If the findings are shown to have an impact, therefore, they will be acceptable and feasible globally, although conflicting healthcare pressures may make implementation variable.
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About the Wellcome Trust
The Wellcome Trust is a global charitable foundation dedicated to achieving extraordinary improvements in human and animal health. It supports the brightest minds in biomedical research and the medical humanities. The Trust’s breadth of support includes public engagement, education and the application of research to improve health. It is independent of both political and commercial interests.
About Imperial College London
Consistently rated amongst the world’s best universities, Imperial College London is a science-based institution with a reputation for excellence in teaching and research that attracts 14 000 students and 6000 staff of the highest international quality. Innovative research at the College explores the interface between science, medicine, engineering and business, delivering practical solutions that improve quality of life and the environment – underpinned by a dynamic enterprise culture.
Since its foundation in 1907, Imperial’s contributions to society have included the discovery of penicillin, the development of holography and the foundations of fibre optics. This commitment to the application of research for the benefit of all continues today, with current focuses including interdisciplinary collaborations to improve global health, tackle climate change, develop sustainable sources of energy and address security challenges.
In 2007, Imperial College London and Imperial College Healthcare NHS Trust formed the UK’s first Academic Health Science Centre. This unique partnership aims to improve the quality of life of patients and populations by taking new discoveries and translating them into new therapies as quickly as possible.
The International Clinical Trial Research Management Office is part of the Division of Medicine at Imperial College and manages a number of large international research grants which include multi-centre clinical trials of HIV prevention technologies and treatment of HIV infection as well as other non-HIV related trials.
About the Medical Research Council Clinical Trials Unit
The Medical Research Council Clinical Trials Unit is one of the UK’s leading centres for clinical research.It specialises in cancer and HIV/AIDS, but also undertakes research in other areas, including tuberculosis, rheumatoid arthritis, and mental health. Unit staff design, conduct, analyse and publish clinical trials, observational studies, meta-analyses and other systematic reviews of clinical or public health importance.