Women sought to help with HIV clinical trial
Posted on 22 September 2009
Women, aged between 18 and 45 and in good health, are being asked to help a team from the Hull York Medical School (HYMS) Experimental Medicine Unit to test a gel that neutralises HIV.
The phase one trial is sponsored by the University of York and York Hospital NHS Foundation Trust in partnership with HYMS.
The microbicide gel is seen as potentially providing a female-controlled defence against HIV which could have a significant impact in helping to restrict the spread of the disease.
The team led by Professor Charles Lacey want to test the safety of the vaginal gel and to gauge how long the gel remains active in the vagina. The trial, which is funded by the European Commission, will involve 30 women. The molecules in the gel which act against HIV have been administered by injection previously and shown to be safe.
Professor Lacey said: “This aims to give women choices about protecting themselves, both in developing countries and in the developed world. We believe this gel may have a long duration of action and perhaps can be used independent of sex – women can apply it at any time.
“We shall screen applicants to make sure that they meet the health criteria for the trial and to establish they have no other condition that might affect the outcome. We need to have a group of women in similarly good health.”
Women who wish to take part in the trial must be available for three months. They will have to attend an initial screening visit to check their general health and suitability for the study. Selected volunteers will then be asked to re-attend on several occasions, beginning two to six weeks after the screening visit.
During this time women will be monitored by Professor Lacey and his team, who will interview participants a month after the trial to assess their views on using the gel.
Testing and monitoring will be carried out by medical staff in the newly opened Experimental Medicine Unit at York Hospital. This Unit has been specifically developed, in partnership with HYMS, to test new medicines.
Volunteers who take part in the study will receive a small payment, and anyone interested should contact David Thompson by telephone at 01904 721893 or email mabgel@yorkhivresearch.org.uk
Further information is available at www.yorkhivresearch.org.uk
ENDS
Notes to editors:
- More information on the University of York www.york.ac.uk
- More information on Hull York Medical School at www.hyms.ac.uk
- More information on York Hospitals NHS Foundation Trust at http://www.yorkhospitals.nhs.uk/
- Clinical trials involving new drugs are classified into four phases. Phase One trials are the first stage of testing in human subjects. Phase 2 and 3 studies are much larger (hundreds to thousands of participants) and take place in a more ‘real life’ setting. New drugs have to pass through the first 3 phases before receiving approval from the regulatory authorities. Phase 4 is post marketing surveillance to observe for rarer or delayed side effects that are not picked up in earlier studies.
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