A phase II double-blind, placebo controlled, randomised, single centre study to assess the safety, tolerability and acceptability of dextrin-2-sulphate (DS) gel in sexually active female subjects and their male sexual partners at low risk of HIV infection
How safe is a gel that might prevent HIV infection?
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 the gel into her vagina before 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 HIV-AIDS is more widespread. A number of gels have been tested to date.
The SHIELD trial aimed to look at the safety of one such gel, called dextrin-2-sulphate (DS). Women who took part in this trial were divided at random into two groups. Women in one group were given the DS gel. Women in the other group were given a placebo gel.
All of the women were asked to use the gel every night over 2 weeks before they had their period. In this first 2 weeks, their male partners were asked to use a condom during sexual intercourse. The women were then asked to use the gel for a further 2 weeks. They were asked not to use condoms during this time. During this second 2 week period, their male partners were asked to take part in a sub-study to look at their experience of the gel, which they would have been in contact with during sexual intercourse.
What difference did this study make?
Based on information from other research, researchers decided to explore higher doses of DS. So the SHIELD trial was closed early, and a new trial called DREAM was developed.
Information collected about the people who took part showed that the DS was safe to use. 11 women (5 of whom received DS, and 6 who were given the placebo) reported bleeding between their periods during gel use. In most cases this bleeding was light and resolved within 24 hours.
Type of study
Who funded the study?
The Medical Research Council.
When did it take place?
This study began recruiting people in 1998 and closed in 2000. The results were published in 2002.
Where did it take place?
This trial took place in the UK.
Who was included?
73 healthy HIV-negative women and 10 male partners took part.