Published on 1 December 2009
Universal access and human rights is key to this year’s World AIDS Day. The European & Developing Countries Clinical Trials Partnership (EDCTP) wishes to express its commitment to fighting HIV/AIDS, a disease that continues to be a major threat to the livelihoods of our global village. By funding research on HIV/AIDS prevention and treatment in Africa where it is so urgently needed, EDCTP and its partners work towards equal access to care.
Sub-Saharan Africa remains the region most heavily affected by HIV. In 2008, sub-Saharan Africa accounted for 67% of HIV infections worldwide, 68% of new HIV infections among adults and 91% of new HIV infections among children. The region also accounted for 72% of the world’s AIDS-related deaths in 2008.
Source: AIDS epidemic update 2009 (UNAIDS)
Partnerships in fighting HIV/AIDS
EDCTP joins European and African countries in the fight against HIV/AIDS, tuberculosis and malaria in Africa. Clinical trials on HIV/AIDS that are funded by EDCTP typically join researchers and research institutes from several European and African countries. They form large research groups that exchange knowledge, train and mentor each other. Their institutions foster and strengthen collaborations which benefit from each other’s expertise.
Funding is provided by EDCTP and its European Members States, national research agencies and institutes, Public-Private Partnerships (PPPs) and Product Development Partnerships (PDPs), as well as the private sector.
EDCTP has set priorities in its HIV/AIDS funding, examples of which are outlined below.
Simplifying HIV treatment
In Africa, access to HIV treatment is often limited because many Africans live far from healthcare facilities and need to travel long distances to a health clinic. Many HIV treatment regimens are very demanding and based on Western circumstances, making it hard for HIV-infected Africans and health systems to comply.
One example of a successful project is the CHAPAS trial on the antiretroviral (ARV) drug Triomune, a three-in one drug used to treat HIV-infected children. Triomune is specifically designed for children.
In August 2007 the FDA gave a tentative approval to Triomune. The follow-up CHAPAS 3 trial expands this work through evaluation of new fixed-dose combinations tablets. Currently Triomune is available in Zambia and Uganda.
Preventing transmission of HIV from mother to child
The risk of mother-to-child transmission of the HIV virus (MTCT) during pregnancy is estimated to vary between 25 and 48%. EDCTP funds trials that aim to protect the child from being infected with HIV during pregnancy, while making sure that the mother receives proper treatment that is safe for the child.
EDCTP-funded clinical trials on HIV MTCT investigate the safety and efficacy of antiretroviral (ARV) regimens containing drugs such as tenofovir, lamivudine and nevirapine, mostly used in combination to prevent drug resistance. Preliminary results of one of the trials already indicate that significant improvements can be made.
Preparing Africa for an HIV vaccine
An effective AIDS vaccine could be the ultimate bullet to shatter the scourge that has ravaged humanity, especially in sub-Saharan Africa. Currently, one vaccine candidate has been successfully tested in humans, and several vaccine candidates are in early development stages.
A large group of funders together with EDCTP have provided support for projects that will ensure that promising HIV vaccine candidates will actually be tested and developed for Africa. The projects involve the development and strengthening of research sites and building cohorts of high-risk groups like adolescents, customers of commercial sex workers and fishermen of the lakes in east and central Africa. Researchers will also assess acceptability of HIV vaccine trials among these populations and study immunological factors that may lead to development of vaccines against the specific strains of the HIV virus that are most common in Africa.
Microbicides as a prevention strategy
Microbicides are products that women could use vaginally to protect themselves against being infected with the HIV virus. Many microbicide trials are ongoing with promising results, but more development and evaluation is needed. Funding commitments are important to continue current developments.
EDCTP provides funding to prepare African sites for future clinical trials on a number of promising microbicides. Among them is PRO 2000 gel, which has already shown a 30% reduction in HIV infections. It is hoped that the EDCTP-funded MDP301 trial results will provide evidence of an even more significant reduction of HIV infections.
HIV and tuberculosis co-infections
HIV fuels the tuberculosis (TB) epidemic and in Africa, it is the single most important factor contributing to the increase of TB since 1990. EDCTP therefore chooses not to work on these two diseases in isolation, but to work on a strategy which incorporates both. Moreover, the emergence of drug resistance affects the development and implementation of prevention and treatment in an increasing pace.
On 15 August 2009, EDCTP launched a call for proposals to support clinical trials on treatment of HIV/AIDS including major co-infections like tuberculosis. With this call, EDCTP aims to increase knowledge about HIV and co-infections thus helping to stop co-infections.
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