End in sight for innovative HIV prevention trials

2014-10-27 16:29

Exciting HIV trials aimed at developing products that can prevent or reduce the risk of HIV transmission from men to women are nearing final stages.

The trials being conducted in South Africa and other countries are testing various prevention tools including a microbicide gel and vaginal rings containing antiretroviral drugs.

The majority of the studies are expected to be completed next year. And if all goes well, the products which are sold by researchers as an empowerment HIV prevention tool for women, will be available in the general market within five years.

Speaking ahead of the HIV Research for Prevention conference which officially begins in Cape Town tomorrow, Sharon Hellier who is a principal researcher at the Microbicide Trials Network (MTN), said the ongoing microbicide trials are an answer for women.

“They give women the power to protect themselves from HIV. We know that some women find it difficult to negotiate safe sex due to various reasons but the discreet gel and vaginal ring gives them the opportunity to use protection without consent from their partners,” said Hellier.

Constant condom use has been the biggest stumbling block in HIV prevention with local and international studies showing that condom use is declining across the world. A more recent local study, 2012 SA National HIV Prevalence, Incidence and Behaviour Survey, – conducted by the Human Sciences Research Council – showed that condom use has decreased significantly in the past five years in men and women aged 15 to 49.

The survey also highlighted that men often have the power to decide on condom use in relationships.

Hellier said it was for this reason that they are empowering women with microbicide products.

“Our whole idea (with microbicides or products developed to prevent the transmission of HIV or other sexually transmitted infections when applied in the vagina or rectum) is to maximise choices so that we can optimise effectiveness,” she said.

Hellier also explained that the advantage of microbicides is effective in such a way that they deliver a lot of drugs to the site of infection, which is the cervix and rectum. The cervix, which is part of the vagina, and anus are high risk areas of HIV infection with the anus being the highest due to the gut being thin and fragile.

The following trials are currently being conducted:

»Tenofovir gel

FACTS 001 is a large-scale trial of 1% tenofovir gel in South African women. It was launched in October 2011 and enrolled nearly 3000 women. The trial is testing the same BAT-24 dosing strategy evaluated in CAPRISA 004.

Results are expected in early- to mid-2015. If this trial confirms the CAPRISA 004 results, the next step would be to present the data to regulatory authorities for possible product licensure and possible access.

The CAPRISA 004 trial in 889 South African women found that tenofovir gel reduced women’s risk of HIV infection via vaginal sex by 39% overall. Women in the trial were counselled to use the gel within 12 hours before and after sex, a regimen known as BAT-24. The results were announced in July 2010.

» Dapivirine ring

Vaginal rings are products made of flexible plastic that fit inside the vagina and provide sustained delivery of drugs over a period of time. Some vaginal rings are already used to deliver hormonal contraception.

The Dapivirine ring is being tested for its ability to reduce the risk of HIV infection. It slowly releases the antiretroviral drug Dapivirine. A new ring has to be inserted every four weeks to maintain drug delivery.

Two current trials are evaluating whether the ring is safe and effective at reducing the risk of HIV infection - ASPIRE (MTN 020) was launched by the Microbicide Trials Network (MTN) in 2012 and enrolled 2629 women in Malawi, South Africa, Uganda and Zimbabwe. Results are expected in late 2015 or early 2016.

The other trial, The Ring Study (IPM 027) is enrolling 1950 women at sites in Uganda and South Africa. Results are expected in late 2016.

» Rectile microbicide

The rectile microbicide 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.

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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