HIV trial ‘could be answer for women’

2012-04-18 10:23

Sydney – Two microbicides clinical trials – one of which is aimed at providing women with a tool to prevent HIV infection without relying on their partners – are about to start in South Africa.

The first trial involves a vaginal ring which will contain an antiretroviral (ARV) drug and the other is an ARV-based rectal gel which will be tested by men who have sex with men.

The ring trial is expected to start in three sites in South Africa in  July or August. The rectal microbicides trial is set to launch early next year.

The ring, which will be made of silicone, will contain a commonly used ARV drug, dapivirine. The drug will continuously release into the vaginal tissue for 28 days. After four weeks it will be removed by the user and replaced with a new one.

The study will be conducted over two years and the result are expected in early 2015.

Said Zeda Rosenberg of the International Partnership for Microbicides: “This is an exciting initiative and if it works it could be the answer that women have been looking for.”

Scientists are hoping that the ring would prevent HIV transmission from men to women during sex.

It is hoped that when the HI virus infects the woman’s healthy cells during sex and later tries to multiply it will be interrupted by the ARVs present in the vaginal tissue.

Over 34 million people are living with HIV in the world and half of them are women. It is further estimated that two-thirds of the 17 million HIV positive women are living in Southern Africa.

Said Rosenberg: “The majority of women acquire HIV through heterosexual intercourse and the only way to prevent further infections is to provide women with a tool they can use without relying on their partners.”

The rectile microbicides gel trial will only recruit men in South Africa at first. Women will be recruited in follow-up trials. Participants will use an ARV-based gel with 1% of the drug tenofovir.

Said Ian McGowan of the Microbicides Trials Network: “It would be unrealistic to exclude women from the trial because they have anal sex as well.

“The gel has been used in several vaginal microbicides trial before and its safety and acceptability in the rectum has been proven. Although at first there were gastrointestinal side effects, we have sorted this out,” he said.

The rectal trial will involve 186 men and transgender women from South Africa, Thailand, Peru and the United States.

Results are expected at the end of 2014.

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