A phase III trial to test the effectiveness of PRO2000/5
How well does a microbicide gel work to prevent HIV infection, and how safe is it?
What is this study about?
The majority of the 25 million adults in sub-Sahara Africa infected with HIV are women. Microbicides are a new range of products under development which might prevent transmission of HIV and other sexually transmitted infections (STIs) when used before sex.
They will be useful for people who cannot, or do not want to, practise abstinence or use condoms. They will be affordable, easy to use and of particular value to women, especially in developing countries where the incidence of HIV-AIDS and other STIs is high.
The Microbicides Development Programme (MDP) is a partnership to develop vaginal microbicides for the prevention of HIV transmission. It brings together academic institutions, non-profit organisations and pharmaceutical companies. The MDP aims to:
- Undertake a trial to test the effectiveness of a candidate microbicide in Africa.
- Conduct social science research into acceptability and barriers to the uptake of microbicides that will subsequently facilitate marketing and access to a successful gel.
- Evaluate new microbicide products in safety studies in the UK and Africa.
The MDP301 trial will test how effective the PRO 2000/5 microbicide gel is at preventing vaginally acquired HIV infection, and how safe the gel is.
Type of study
Who is funding the study?
The trial is funded by the UK Department for International Development and the MRC and is administered by the MRC Clinical Trials Unit and Imperial College London.
When is it taking place?
This trial started recruiting women in October 2005. Recruitment closed on the 15th of August 2008 and follow up was completed on 18th September 2009.
Where is it taking place?
Recruitment took place in Tanzania, Uganda, Zambia and three sites in South Africa.
Who is included?
We recruited 9,404 sexually active women.