HIV clinical trials London
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."
The Patients Voice in HIV/AIDS Clinical Trial Participation: What motivates the willingness of HIV infected people to take part in HIV/AIDS clinical trials?
Book (LAP LAMBERT Academic Publishing)
BMC Medical Research Methodology at the 35th Annual Conference of the .. — BMC Pediatrics
The conference will focus on issues such as design and analysis of clinical trials, methods in biostatistics and development of clinical prediction models.
What is the HIV rate in New York?
About 72 cases per 100,000 which is about three times the national average.