A Duel centre dose-Ranging trial of Emmelle (dextrin sulphate) gel in preparation for an African Microbicide trial
Testing the safety of a vaginal gel to prevent HIV infection before it is used more widely in Africa
What was this study about?
One way in which researchers are trying to prevent the spread of HIV is through a gel which a woman inserts into her vagina before having sexual intercourse. Such a gel would be useful for people who cannot, or do not want to, practice abstinence or use condoms. They could be of particular value to women, especially in developing countries where the incidence of HIV-AIDS is high. A number of gels have been tested to date.
The DREAM trial aimed to look at the safety of a gel containing dextrin sulphate (DS, also called Emmelle). It followed the SHIELD trial. The DREAM trial looked for the highest possible dose of Emmelle that would be safe to give in a vaginal gel.
This trial had 2 parts. In the first part of the trial, HIV negative women were randomised into 3 groups:
- Women in the first group were given a gel which contained 4% DS
- Women in the second group were given a gel which contained 1% DS
- Women in the third group were given a placebo gel
After this first part, researchers agreed to continue to test the 4% gel. In this second part of the trial:
- One group of HIV negative women were given the 4% gel
- A second group of HIV negative women were given a placebo
- A group of HIV positive women were given the 4% gel
What difference did this study make?
Researchers were surprised by the number of women who had some spotting (bleeding) between their periods in the first part of this trial. But more women who used the placebo gel had spotting than those who used the gel which contained DS.
Because of this finding, researchers included a new group to the second part of the trial. This group were given no gel and acted as a control group. In this second part of the trial, we found that women who had the 4% gel had significantly more bleeding between their periods than those who received no gel.
Overall, it seemed that the bleeding did not seem related to the DS itself. It was therefore decided to continue with the next trial, MIA 001, after amending the design of this slightly and ensuring that a safety review took place early on in the trial.
Type of study
Who funded the study?
The drugs company ML Laboratories PLC.
When did it take place?
This study began recruiting people in 2000 and closed in 2001. The results were published in 2002.
Where did it take place?
Women attended centres in Antwerp and London.
Who was included?
50 HIV negative women took part in the first part of this trial. 30 HIV negative women took part in the second part of this trial. 20 HIV positive women took part in the second part of this trial.