A randomised, vaginal microbicide trial to assess the safety of dextrin sulphate gel 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-Saharan Africa infected with HIV are women. Researchers are developing a new range of products called microbicides. Microbicides 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.
A number of gels have been tested to date. The MIA 001 trial aimed to look at the safety of a gel containing dextrin sulphate (DS). It followed the SHIELD trial and the DREAM trial, both of which had taken place in Europe.
The aim of the MIA 001 study was to look at the safety of using DS gel either twice daily or before sex only in women in Uganda. The DREAM trial had found that the highest dose for European women was 4% DS – although researchers were concerned that some women had bleeding between their periods. Because of this concern, the MIA 001 trial was designed in two parts. In the first part of the trial, 35 HIV negative women were given the DS gel to use twice daily, DS gel to use before sex only, a placebo gel or no gel.
Researchers then looked at the results of this part of the trial before moving to the second part. In the second part of the trial, a further 65 HIV negative women were given either the DS gel or a placebo gel to use twice daily. HIV infected women whose partners were also HIV infected also took part in this second part of the trial.
What difference did this study make?
This trial led researchers to conclude that DS gel was safe to test further.
Vaginal bleeding was reported as frequently by participants who were given the gel with DS as by participants who were given the placebo gel, or who had no gel. DS gel appeared to be acceptable to over 95% of the users.
Type of study
Who funded the study?
This trial was funded by the European Commission.
When did it take place?
This study began recruiting women in August 2001 and closed in November 2002. The results were published in 2005.
Where did it take place?
Who was included?
109 women took part in this trial.