Monday 1 December is World AIDS Day 2014. The theme for World AIDS Day 2014 is “Focus, Partner, Achieve: An AIDS-free generation”. At MRC CTU at UCL, our studies are targeted towards this aim in a variety of ways.
Our current studies are focussed both on preventing HIV transmission and also on how to treat people who are already infected with HIV. We also work collaboratively with a range of partners – from community groups to patient representatives – in order to ensure that our research is effectively carried out and affects change where change is most needed: on the ground.
One example of the prevention work that we are doing is the PROUD study, which is based in the UK. The study is looking at whether a taking a daily tablet, called Truvada-PrEP, can safely reduce the risk of gay men and other men who have sex with men being infected with HIV.
The rate of HIV infection amongst men who have sex with men living in the UK is high, and is still rising. In 2012, over 3,250 people men in this group tested positive, which is the highest figure ever reported.
The Trial Management Group worked with community groups and representatives to best plan the running of the trial. They also held meetings with trial participants, to get their views on research priorities and study procedures.
The results of the interim analysis of the data collected in the PROUD study were announced in October 2014. These results show that Truvada-PrEP is highly protective against HIV for gay men and other men who have sex with men at high risk of infection. On this basis, we have offered participants on the deferred arm of the study (who have not yet started PrEP) the opportunity to start PrEP early.
This result is a major step forward towards the control of HIV transmission in gay men in the UK. The final results will provide evidence to support making PrEP available on the NHS, and pave the way for future research into PrEP regimens.
Many of our current HIV studies are conducting research in treatment. For example, the START study, which is aimed at answering an important unanswered question in HIV treatment: when is the best time to start HIV medications?
START is aiming to evaluate whether starting HIV medicines earlier than current practice will reduce the risk of developing traditional AIDS illnesses or other serious non-AIDS illnesses. It is a large, global study which has enrolled 4,688 participants in 36 countries across the world. Whatever the findings of the trial, the size of the study and the amount of data it collects will be a valuable resource for future research against HIV.
Another of our current studies is a randomised controlled trial called REALITY. The trial is taking place in Uganda, Zimbabwe, Malawi and Kenya, and is testing three new methods of treatment aimed at reducing deaths amongst people with AIDS.
Like START, the patients who are taking part in the REALITY trial already have HIV-infection but have never received antiretroviral therapy (ART) against the infection before participating in the trial. The patients taking part in REALITY have low CD4 counts (a measure of how effectively their immune system is functioning). Each person who joins the trial has a CD4 count below 100, meaning that the HIV virus has progressed significantly and is severely impacting their immune system.
REALITY compares three methods of treatment that take place over the first 12 weeks of treatment. All are aimed at reducing early mortality in the participants. The first method involves increasing their dose of ART, and the second involves an additional medication against additional infections. The third method involves taking a nutritional supplement. These are all compared against the current standard of care.
There are still significant numbers of people in sub-Saharan Africa with an advanced stage of HIV who have not yet received any form of ART. We hope the REALITY trial will tell us how we can reduce deaths among these people.
Unusually for the MRC CTU at UCL, Lablite is working on healthcare systems research in Uganda, Malawi and Zimbabwe outside of the context of clinical trials. Together these 3 countries are home to 11% of the total number of people living with HIV across the world.
The UN Millennium Development Goals aimed to achieve universal access to treatment for HIV/AIDS by 2010. This has not yet been achieved, particularly in countries like Malawi, Uganda and Zimbabwe, where the majority of the population live in rural areas.
Lablite follows on from the work of the DART and ARROW trials. The aim of the project is to increase access to HIV treatment for people living in rural areas by decentralising healthcare provision. This means moving centres of treatment away from major hospitals in urban areas, and into local, smaller-scale health centres.
The DART trial demonstrated how effective ART is at keeping people with HIV alive. The work of the Lablite project is not about testing a new treatment, but about making sure that people living in rural areas of Malawi, Uganda and Zimbabwe can access treatment.
Achieving an AIDS-free generation
Research like this is vital if we are to achieve “an AIDS-free generation”. It is only made possible thanks to the partnership of doctors, nurses, researchers, people living with HIV, community groups, national governments and funders.