20th World AIDS Day - 1 December 2008
EDCTP continues to empower Africa to prevent and treat HIV/AIDS
On 1 December 2008 the European and Developing Countries Clinical Trials Partnership (EDCTP) joins the world to commemorate the 20th World AIDS Day and wishes to express its commitment to the theme "Lead - Empower - Deliver". HIV/AIDS continues to be a major threat to the livelihoods of our global village. Recently the United Nations Joint Programme on HIV/AIDS (UNAIDS) stated that global estimates of the HIV epidemic have stabilised. Despite this observation statistics still show unacceptably high levels of new HIV infections and AIDS deaths. The report states that in 2007, there were an estimated 33 million people living with HIV worldwide. The UNAIDS report also shows that in 2007, 35% of new HIV infections and 38% of AIDS deaths were from Southern Africa and that 67% of all people living with HIV live sub-Saharan Africa. These are alarming statistics that call for joint and accelerated action.
EDCTP's strategy for HIV drugs, vaccines and microbicides
EDCTP joins European and African countries in a concerted action to empower sub-Saharan Africa to alleviate the burden of HIV/AIDS by accelerating the development of drugs, vaccines and microbicides. We urgently need to revaluate existing interventions and accelerate the discovery and development of new or improved interventions. In its joint programme of action EDCTP has targeted to fund clinical trials for HIV/AIDS drugs, vaccines and microbicides while actively developing human capacity and infrastructure for clinical research in sub-Saharan Africa.
HIV treatment
The main drug trials needed in developing countries, especially in Africa, are those that address regimens with lower overall drug exposure (to reduce cost, complexity and resistance) and those that investigate what are the optimal starting times, and means of monitoring and managing drug use both in children and in adults. The latter includes trials on prevention of HIV transmission from mother to child (MTCT) and pharmacokinetics of existing regimens. The objectives for EDCTP therefore include to:
* Simplify and standardise ARV regimens in adults and children
* Develop new treatment strategies
* Prevent Mother to child transmission of HIV
* Treat opportunistic infections.
Examples of HIV treatment research projects funded by EDCTP are:
* HIV Treatment - CHAPAS Trials: Children with HIV in Africa: Pharmacokinetics and Adherence of Simple Antiretroviral Regimens (Zambia)
* HIV/PMTCT - Back-up with AZT/3TC or single dose FTC/TDF in order to avoid NNRTI resistance after single dose NVP for PMTCT (Tanzania)
* HIV/PMTCT - Improving the balance between efficacy and development of resistance in women receiving single dose nevirapine (Zambia)
* HIV/PMTCT - Impact of HAART during pregnancy and breastfeeding on MTCT and Mothers Health: The Kesho Bora Study (South Africa)
* HIV/PMTCT - A double blind randomised placebocontrolled trial of the efficacy and safety of infant peri-exposure prophylaxis with lamivudine to prevent HIV-1 transmission by breastfeeding (Burkina Faso, South Africa, Uganda and Zambia)
HIV Vaccines
Currently there is no successfully tested HIV vaccine for humans. In addition there are few, if any, research sites in Africa with the capacity for conducting clinical trials of HIV vaccines. Therefore, the EDCTP objectives for vaccine development are to:
* Develop the capacity to measure HIV incidence in defined cohorts
* Prepare selected sites to conduct Phase II trials with candidate vaccines
* Conduct of Phase II studies at African sites
* Pursue clinical development of promising prophylactic and immuno-therapeutic vaccines.
HIV vaccines research currently funded by EDCTP:
* Strengthening long-term clinical and lab research capacity, cohort development and collection of baseline data in Uganda and Malawi for future vaccine trials (Uganda and Malawi)
* Capacity development and strengthening in preparation for HIV vaccine trials in Tanzania and Burkina Faso
* Building capacity of Infant HIV-1 Vaccine Clinical Trial Centres in Nairobi, Kenya and Fajara, The Gambia
* Feasibility of and capacity building for adolescent HIV vaccine trials in South Africa
* HIV vaccine trial capacity building in Tanzania and Mozambique by continued exploration of optimal DNA priming and MVA boosting strategies (Tanzania and Mozambique)
* African-European HIV Vaccine Development Network (South Africa, Tanzania and Mozambique)
Microbicides
Microbicide research is relatively new and a concerted effort is required to find the best strategies in microbicide development. The EDCTP objectives in this area are to:
* Generate safety data on uninfected women and men and also in HIV-infected persons
* Develop capacity for Phase II/III trials
* Conduct Phase II/III trials.
Examples of microbicides research projects funded by EDCTP are:
* Preparing for Phase II vaginal microbicide trials in Rwanda and Kenya: Preparedness studies, capacity building and strengthening of medical referral systems (Rwanda and Kenya)
* Site preparation and capacity strengthening for trials of vaginal microbicides in Tanzania and Uganda (Tanzania)
* Establishing HIV microbicides clinical trial capacity in Mozambique and expanding an existing site in South Africa (Mozambique and South Africa)
HIV and TB co-infections
HIV fuels the TB epidemic and in Africa, and it is the single most important factor contributing to the increase in incidence 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. However, the diagnosis and control of TB is greatly hampered by lack of sensitive, quick and affordable diagnostic tools. This affects not only the conduct of clinical trials, but also delivery of appropriate treatment and prevention. Therefore EDCTP in 2009 will launch an open call for the development of a more effective TB diagnostic tool is an essential component for both clinical research and treatment.
More information:
* Official website World AIDS Day 2008 <http://worldaidsday.org/>
* UNAIDS website <http://www.unaids.org/>
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Daniela Pereira
mailto:Pereira@edctp.org