An open phase I trial of 13% cellulose acetate phthalate vaginal microbicide with randomisation to an observation control

How safe is it to use a substance called CAP as a vaginal gel?

What was this study about?

AIDS is the infectious disease that kills most people in the world. So there’s an urgent need not just to find a cure, but also to find a way of preventing it. The MRC CTU has been involved in a project to develop a gel which women could insert into their vaginas before they have sexual intercourse. We hope that a gel like this could help prevent women catching HIV.

CAP was an open label, phase I trial that aimed to test the safety of a substance called cellulose acetate phthalate (CAP).

There were two parts to this trial. Part A was designed to look at how 10 women who did not have HIV reacted to the gel immediately after using it. If there were OK, they were then asked to use the gel every day for 14 days.

Part B of the study aimed to look at 50 women. 40 of them were HIV negative. 10 were HIV infected.

What difference did this study make?

The trial was stopped early after 5 patients had been recruited to Part A. It was found that this particular formulation of the microbicide gel was unacceptable. A different formulation was developed and used in later studies.

Type of study

Randomised trial

Contact details

Who funded the study?

This study was funded by the Medical Research Council and the UK Government’s Department for International Development Microbicide Development Programme.

When did it take place?

This study took place in 2004.

Who was included?

This study aimed to recruit 60 people. But it was stopped after only 5 people had agreed to take part as the gel became very liquid and this was unacceptable.