Conducting tests on 24 women between the ages of 18 – 50, the trial will take place in a dedicated research facility at York Hospital. It will investigate how vaginal gels, known as microbicides, could be used by women to prevent the Human Immunodeficiency Virus (HIV) from spreading.
Drugs which work against HIV are called antiretrovirals (ARVs). Current microbicide gels contain only one of two ARVs, known as Dapivirine and Darunavir. Dapivirine has been used in a previous successful clinical trial and Darunavir has been widely used as an oral tablet to treat people with HIV.
For the first time, a gel containing both ARVs will be trialled for internal application. Volunteers will be monitored to assess how safe the gel is, how long the active ingredients stay in the vagina and whether they are absorbed into the bloodstream. Laboratory based culture tests on genital tract samples will also be undertaken to determine whether the ARVs would be capable of neutralising and blocking the replication of HIV in the cervical cell lining.
Dr Heather Hilliard, a member of the Research team at the York Clinical Research Facility at York Hospital, said: “Throughout the world the most common way in which HIV spreads is through sexual intercourse between men and women. Although condoms are effective in preventing the transmission of HIV, it is not always possible for a woman to get her partner to agree to use them. Therefore, there is an urgent need for other methods of protection that can be used by women.
“The development of microbicide gels, applied inside the vagina using an applicator before sexual intercourse, would mean that women would be able to protect themselves from HIV without necessarily having to discuss this with their partners.”
Professor Charles Lacey, Chair of Clinical Medicine at Hull York Medical School (HYMS) and the Centre for Immunology and Infection at the University of York, and Honorary Consultant Physician in GU/HIV Medicine at York Hospitals Foundation Trust, said: “A microbicide gel containing two different ARVs will theoretically be more effective than current one-drug methods, as it will likely reduce the possibility of the HIV virus becoming resistant, which is a possible danger when using only one ARV.
“The DAPIDAR trial will test the effects of using the vaginal microbicide gel once and also when it is used every day for two weeks. From previous research done using the active ingredients in this microbicide gel in humans, we expect the product to be safe. We hope that people at risk of HIV infection will ultimately benefit from this study, which is especially relevant to people in developing countries where HIV is a major problem.”
For further information about the trial and for information for potential volunteers, visit: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=18176
Source: University of York