A randomised, placebo controlled, vaginal microbicide trial assessing the safety of PRO 2000/5 Gel (P) versus vehicle placebo in Uganda
Testing the safety of a vaginal gel to prevent HIV infection
What was 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, practice 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 MIA 002 trial aimed to look at the safety of a gel called PRO 2000/5 in two different strengths – 0.5% and 2%. It compared results between women using each concentration of the gel twice daily with women using a placebo gel twice daily, and women using no gel.
This study enabled researchers to develop a phase III trial – MDP301.
What difference did this study make?
Both concentrations of the PRO 2000/5 gel were found to be safe and acceptable to women.
Type of study
Who funded the study?
This project was funded by the Medical Research Council (UK) and International Collaboration with Developing Countries Programme of the European Commission and supported by Imperial College, London. Indevus Pharmaceuticals, Inc. supplied PRO 2000 gel.
When did it take place?
This study began recruiting women in June 2003 and closed in September 2004. The results were published in 2010.
Where did it take place?
Who was included?
180 women in Uganda took part in this trial.