The Department for International Development (DfID) has awarded a grant of £16 million to the UK's Medical Research Council (MRC) for a five-year programme of research on microbicide gels, aimed at preventing HIV and other sexually transmitted infections.
The new programme brings together researchers in Cameroon, South Africa, Tanzania, Uganda and Zambia with those in several UK institutions. The principal investigators, based in London, are Dr Charles Lacey at the Imperial College Faculty of Medicine and Dr Sheena McCormack at the MRC Clinical Trials Unit.
The programme will take two products - named as Interneuron's PRO 2000 (naphthalene sulphonate polymer gel) and ML Laboratories' Emmelle (dextrin sulphate gel) - into full scale double-blind placebo-controlled clinical trials. These will be designed to find out whether the products protect women from vaginal transmission of HIV and, if so, how. Animal studies have suggested that both products may be able to give some protection against HIV-related viruses. Both products have already been tested by women volunteers in small safety studies in the UK, Belgium and Uganda (Emmelle) or the UK, USA, Belgium and South Africa (PRO 2000). They have been shown not to cause the inflammation which stopped the development of previous microbicides, based on nonoxynol-9.
This new programme complements the full-scale trials planned by the US National Institutes of Health (for PRO 2000 and BufferGel) and the Population Council (CarraGuard). It also aims to lay the foundations for testing the next generation of candidate microbicides. It is hoped that future products will show higher efficacy than is expected for the present ones and may prevent transmission of the virus through anal sex as well as penis-vagina sex. There is talk of producing a choice of microbicides which are either contraceptive or allow pregnancy, although it is still not altogether clear how the contraceptive effects of any microbicides will be evaluated.
The launch event, in DfID's London headquarters, was hosted by Clare Short MP, Britain's Secretary of State for International Development, who spoke of the need to invest in health to combat poverty. It was held jointly with the MRC and the Rockefeller Foundation, which has just announced no less than five reports on priorities for microbicide development (for an executive summary in pdf format, click here). A key claim, based on models developed by the London School of Hygiene and Tropical Medicine, is that a 60 per cent effective microbicide, used half of the time by people who could easily be reached through existing services, could prevent as many as 2.5 million new HIV infections every year.
Dr Geeta Rao Gupta, Director of the US-based International Center for Research on Women, spoke of the need for woman-controlled methods of HIV prevention, which microbicides promise to meet. However, Dr Alan Stone of the International Working Group on Microbicides pointed out that microbicides would be equally likely to protect men from exposure to HIV from women, even though it would be impractical to set up clinical trials to prove it.
The Rockefeller Foundation, which was the prime mover in setting up the International AIDS Vaccine Initiative, is now sponsoring a similar public-private partnership for microbicides, with an acting Executive Director, Zeda Rosenberg, based at Family Health International in the USA. This will operate with three advisory committees, one focussed on the scientific issues and clinical pipeline, a second on developing clinical trial sites, and a third on advocacy for access to future microbicides. It is clearly intended to complement and build on existing inter-agency coalitions in the microbicides field, rather than to compete with them.
For an overview of microbicide development, click here. There are additional information sources listed in aidsmap's Links section.