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MRC Clinical Trials Unit on World AIDS Day 2010

01 December 2010

1st December 2010 marks the 22nd World AIDS Day - an annual reminder that that the HIV epidemic has not gone away and that there are still many things to be done. The theme this year is "Universal access and Human Rights" and the day falls just after the UNAIDS 2010 progress report was published. Globally, the report has a note of cautious optimism - there were 2.6 million new infections in 2009, down from 3.1 in 1999. AIDS-related deaths in 2009 numbered 1.8 million - down from 2.1 million in 2004.

However, the report highlights some of the inequalities in HIV that the MRC Clinical Trials Unit (CTU) has been working hard to address over the past few years. It states, for example, that whilst the epidemic in sub-Saharan Africa is stable or declining and antiretroviral therapy (ART) coverage has increased by 9% since 2008, in 2009 only 3.9 of the 10.6 million people in need of ART were getting it. HIV prevalence among adults is 5% in the same region - 4% more than in any other region - and there are now 2.5 million children under the age of 15 living with HIV worldwide.

The MRC CTU has been instrumental in two major HIV trial publications since the last World AIDS Day in 2009, both of which were working with sub-Saharan populations: DART and MDP301. DART, the largest clinical trial of ART for people with HIV infection in Africa, demonstrated that regular laboratory tests offer little additional clinical benefit to populations when compared to careful clinical monitoring, opening up the way for decentralised ART delivery. MDP301, the largest international clinical trial to date into a preventative HIV gel, found PRO2000 gel safe and highly acceptable to women and their partners. Although there was no evidence of effectiveness with PRO2000, through their participation in MDP301 over 20,000 women were given counselling to help them practice and negotiate safe sex and lead healthier lives.

These landmark trials, along with other ongoing research, demonstrate CTU's commitment to research which benefits those least equal in the fight against HIV. Decentralising ART delivery significantly reduces the cost of HIV treatment and widens access to those who have no means or are too sick to travel large distances to get the treatment they need. In the light of the CAPRISA 004 tenofovir results - a microbicide gel which showed 39% success rate in prevention of HIV infection - the 89% reported gel use in MDP is extremely significant, indicating that an effective formulation would be widely used across female sub-Saharan populations.

CTU scientists are working alongside other groups to investigate strategies for early treatment of HIV. The main question addressed by SPARTAC - a trial which will report its results in 2011 - is whether a short period of treatment in the initial stages of infection can delay the need for treatment in the longer term. The research is being carried in Africa, Europe, Australia and Brazil and could have significant results for scientists looking at the long-term effects of HIV therapies. START, an ongoing international trial, is investigating the optimal time of starting anti-HIV treatment. 

MRC CTU also has a broad range of activities relating to childhood HIV in Africa and elsewhere. The African trials aim to provide evidence of how to treat large numbers of children through development of simplified, cost-effective, easily administered treatment regimens which can be delivered by healthcare workers in areas where sophisticated facilities are not available - more than 70% children in Africa live in rural areas. This includes the ARROW, CHAPAS and CHER trials.  CTU also coordinates trials in Europe, Thailand and the Americas through Paediatric European Network for the Treatment of AIDS and works closely with the adult HIV infections group, to ensure that paediatric trials focus on questions that are either child-specific or where answers may differ from adults.

The major trials in Africa have, through CTU's collaboration with African partners, had an important secondary effect - showing that research excellence can be achieved in an African setting. The trials have built research capacity in Africa and forged strong links with African scientists who have become world leaders in the field. More than this, participation in the clinical trials has created a strong community spirit in their participant populations. Many participants have become HIV activists in their local communities, encouraging their peers to be tested for HIV, and to seek treatment when they become unwell. Their example has helped to reduce the stigma that is still associated with positive HIV status and to disseminate HIV prevention messages.

Whilst World AIDS day 2010 is a chance to look back over the devastation of nearly 30 years of the HIV epidemic with some hope, it is also a reminder that there is a long way to go before there is equal access to treatment and preventative measures across major cultural, geographic and gender divides.