10,000 African women to take part in a major HIV prevention trial
25 October 2005
Healthy women in Uganda and South Africa are enrolling this week in a trial to test a microbicide – PRO 2000 – which aims to protect against HIV and other sexually transmitted infections. The trial, which has been developed by the Microbicides Development Programme (MDP), is opening at clinics in Johannesburg, South Africa and the Masaka district in Uganda. It will expand to other sites in South Africa, Tanzania and Zambia by the end of the year. It is a key component of the £42m Programme, funded by the UK Government’s Department for International Development (DfID) and the Medical Research Council (MRC), and co-ordinated by the MRC Clinical Trials Unit (CTU) and Imperial College, London, in collaboration with a number of other academic and research institutions in Africa and the UK.
PRO 2000 is a topical vaginal microbicide developed as a gel by the US pharmaceutical company Indevus. The compound has been shown in laboratory tests to block the entry of HIV in human cells and to protect animals against infection. In addition to its demonstrated activity against HIV infection, it has also been shown to be effective in the laboratory against other STI pathogens such as herpes, chlamydia, and the bacterium that causes gonorrhoea.
Approximately 10,000 healthy women will take part in this trial, which is expected to last three to four years. Each woman will be randomly assigned to receive a placebo or PRO 2000 at one of two strengths (0.5% or 2%). The women will be asked to apply the product prior to sexual intercourse. In addition, all participants will receive condoms and risk-reduction counselling at trial entry and subsequent clinic visits. The trial will evaluate the effectiveness of PRO 2000 in preventing HIV as well as gonorrhoea, herpes and chlamydia. Safety data will be reviewed regularly by an independent data safety monitoring committee.
Over half of all people living with HIV in the developing world are women, with the majority of new adult infections acquired through heterosexual intercourse. In addition, more than 400 million new cases of STIs occur each year. Dr Anatoli Kamali of the MRC unit in Uganda and the lead scientist for the Masaka site said, “There is a significant need among sexually active women for female-controlled methods of HIV and STI prevention. The highest HIV infection rates are found in sub-Saharan Africa, which is why these large-scale trials are being conducted in this area.” Dr Sibongile Walaza of the Reproductive Health Research Unit in Johannesburg added, “If microbicides are shown to be effective, they would ideally be used in addition to condoms, but even on their own they could significantly reduce transmission of HIV and STIs.”
The trial is coordinated by the MRC’s Clinical Trials Unit, where the data from the sites will be combined for analysis. The clinical trials manager, Julie Bakobaki said, “Early safety studies of this particular microbicide have been extremely encouraging. It’s very exciting after four years of preparatory work to reach the point of enrollment into this trial. Showing this microbicide protects against HIV would represent a tremendous breakthrough in the fight against the spread of HIV/AIDs.”
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Note to Editors
- Medical Research Council Programme on AIDS in Uganda, Masaka, Uganda
- Reproductive Health Research Unit, Chris Hani Baragwanath Hospital, Johannesburg, South Africa
- Medical Research Council (South Africa) Durban, South Africa
- Africa Centre for Health and Population Studies, Mtubatuba, South Africa
- LSHTM/NIMR/AMREF Collaborative Research Projects, Mwanza, Tanzania
- University of Zambia School of Medicine, MDP Zambia, Mazabuka
- Medical Research Council (South Africa), Durban, South Africa
- Reproductive Health and Research Unit, University of the Witswatersrand, Johannesburg, South Africa
- The Africa Centre for Health and Population Studies, Somkhele, KwaZulu Natal, South Africa
- African Medical and Research Foundation (AMREF) and the National Institute for Medical Research (NIMR), Mwanza, Tanzania
- Uganda Virus Research Institute/Medical Research Council, Entebbe, Uganda
- University Teaching Hospital, Lusaka, Zambia
- Contract Laboratory Services, Johannesburg, South Africa
- London School of Hygiene and Tropical Medicine, London, UK
- MRC Social and Public Health Sciences Unit, University of Glasgow, UK
- St George’s Hospital Medical School, London, UK
- Southampton University, Southampton, UK
- Population Services International (Europe), UK
- University of York, UK
- Eradicate extreme poverty and hunger
- Achieve universal primary education
- Promote gender equality and empower women
- Reduce child mortality
- Improve maternal health
- Combat HIV/AIDS, malaria and other diseases
- Ensure environmental sustainability
- Develop a global partnership for development
