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HIV gels for women begin trials

28th July 2009

A conference in South Africa has heard that a new generation of gels is undergoing tests in the hope of producing an effective way for women to protect themselves from HIV/AIDS.

hiv

So far, trials of antiretroviral microbicides have raised hopes, but ended in disappointment. Results of the last of the 'first generation' gels, PRO 2000 are still in the pipeline, with Phase III trial results expected later in the year.

Two international partnership organisations are preparing for Phase I trials of vaginal gels or rings containing anti-HIV drugs, researchers said.

The U.S.-funded International Partnership for Microbicides (IPM) and the Microbicide Trials Network (MTN), hope that the products, which contain antiretroviral drugs, will inhibit HIV infection in women.

In the absence of an AIDS vaccine, specialists say development of a microbicide is needed to protect women whose partners refuse to use condoms, particularly in poorer countries.

Trials of a number of microbicides, which can be applied by women in the form of gels, films, creams and sponges, have all failed so far to produce a safe, effective candidate to prevent transmission of HIV and other sexually transmitted diseases.

The new generation of topical antiretrovirals (ARVs) are intended to inhibit HIV infection by blocking the virus from replicating in the cells it initially infects.

Vaginal rings can be inserted to give protection in the case of unanticipated sex, while gels would need to be carried around and applied before sex, IPM chief executive Zeda Rosenberg said at the 5th International AIDS Society (IAS) conference in Cape Town.

The purpose of the trials is to investigate the effectiveness and usability of the two different approaches.

Rosenberg said she hoped the drugs could be offered in various forms such as gels, tablets or rings, giving a women a choice.

In one trial conducted by MTN, researchers will compare a gel containing the antiretroviral tenofovir with a placebo gel, tenofovir tablets, tablets containing both tenofovir and emtricitabine, another antiretroviral and placebo tablets.

The team has already begun recruiting 5,000 southern African women for the study, who will receive safer sex counselling and a supply of condoms.

Meanwhile, trials of rectal gels for men and women, and those investigating safety of tenofovir gels in pregnant women will also begin, alongside an IPM phase I/II safety trial of a gel containing the ARV dapirivine.
 
Participants who acquire HIV during the trials are offered treatment and are invited to enrol in MTN0015, a long-term observational study.

Experts running previous microbicidal gel trials say women report finding them empowering, as they find it easier to communicate within relationships about safe sex and condom use after participating.

They say a marketable microbicide is still several years away, however.


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Comments

Anonymous

Tuesday 28th July 2009 @ 12:26

It is innacurate to say that "development of a microbicide is needed to protect women whose partners refuse to use condoms, particularly in poorer countries."

Microbicides are also developed for women who do not want to use condoms (because they want to get pregant for example) or for woman and men who do not have access to condoms.

Holly Seltzer

Tuesday 28th July 2009 @ 22:04

Thank you for your coverage. Microbicides based on the same antiretroviral (ARV) drugs that have proven effective in treatment could indeed give women the upper hand in the fight against HIV. While there is still a long way to go, it is inaccurate to say that trials of antiretroviral microbicides have so far “ended in disappointment.” To date, no ARV-based microbicide trial has reported efficacy results.

The ongoing PRO2000 study is testing the last of the “first generation” microbicide candidates, which are based on non-specific antimicrobial agents. While previous first generation microbicide studies have been largely disappointing, the field is focusing on “next generation” ARV-based candidates that specifically target HIV and can be used in novel, longer-lasting formulations. IPM is focusing on ARV-based products such as gels that would be used daily and independent of the time of sex, as well as vaginal rings that could potentially protect women for up to a month.

With support from 12 European and North American donor governments (including the UK), foundations, industry, and scientists and partners in many developing countries, IPM is committed to developing safe and effective microbicides and making them accessible to all women who need them as quickly as possible.

Holly Seltzer
Senior Communications Officer
International Partnership for Microbicides


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