Story URL: http://news.medill.northwestern.edu/chicago/news.aspx?id=179680
Story Retrieval Date: 8/28/2014 4:12:59 AM CST

Top Stories
Features

Alison W. Bullock & Katherine LaGrave/MEDILL

HIV prevention may now be possible through genetically engineered crops.  Chicago residents express their thoughts. 


Successful clinical trial may give women a new way to prevent HIV

by Alison W. Bullock
Feb 24, 2011


HIV_FYIMAGE

Alison W. Bullock/MEDILL

Federal funding for the global fight against HIV/AIDS has increased only slightly in the last three years. Click on chart to see full-size image. 

HIV_CATEGORYIMAGE

Alison W. Bullock/MEDILL

The majority of HIV/AIDS funding by the U.S. in 2011 will go toward domestic care and treatment programs. Click on chart to see full-size image.

HIV_TRIALS

Alison W. Bullock/MEDILL

Ongoing microbicides trials in the U.S. and abroad. Click on map to see full-size image.

Related Links

Genetically modified plants offer hope for HIV preventionMicrobicide Trials Network

National Women and Girls HIV/AIDS Awareness Day

Pin the protection, condom relay races and safer sex Jeopardy are just a few of the games you can play at the University of Illinois at Chicago’s Safer Sex Fest. The event is being hosted by the university’s Center for Research on Women and Gender on March 9 in observance of National Women and Girls HIV/AIDS Awareness day.

The Safer Sex Fest is in its second year at UIC.

“The goal is to raise awareness about women’s sexual health risk, and also raise awareness on how to protect themselves from STIs and HIV,” said Kristine Zimmerman, community outreach director at the center.

While the event focuses on women’s health, Zimmerman said it is important for everyone to get more comfortable with the idea of safer sex.

“Every game, no matter how silly, has a purpose,” she said.

The event is free and open to the public.

Date: March 9, 2011
Time: 3pm – 5pm
Location: UIC Student Center East, Room 302
750 S. Halsted Street
Chicago, IL 60607

 
Women in the U.S. may have a new way to protect themselves from HIV as early as 2014, some experts say. The success of a clinical trial done in South Africa in July has shown effectiveness in a preventive method called a microbicide.

Microbicides are gels or foams that contain a variety of chemical substances that can destroy some bacteria that cause infection – like HIV. Some are even being made out of genetically engineered crops. While no microbicides are currently on the market, they are being studied and tested to reduce the infection rate of HIV and other sexually transmitted infections.

“A gel with moderate effectiveness could save hundreds of thousands of lives over the course of a few years,” said Jim Pickett, director of prevention advocacy at the AIDS Foundation of Chicago.

Research in the U.S. and overseas is in different stages of clinical trials that could have the product on the market within the next three to 10 years.

Why microbicides for HIV prevention?
The availability of a microbicide would offer an alternative form of prevention for women who may not have access to condoms or partners willing to use them. Women would apply a gel vaginally prior to and following intercourse.

Pickett pointed out that microbicides are a measure for women to protect themselves from HIV in countries where they may have low social status, or in situations where they may not be able to negotiate male condom use.

Though initial research was geared toward protecting women in sub-Saharan Africa from HIV, low-income communities in Chicago could also benefit from the production of an effective microbicide.

Ashley Mojica, an AIDS caseworker at the Howard Area Community Center in North Chicago, said the center’s main clientele are low-income minorities. Women use their health services most.

“This would be beneficial and important to women in our neighborhood, because they are very interested in protecting themselves,” Mojica said.

Male condoms are the main form of prevention for HIV around the world. Some men choose not to use condoms, and others are not educated on how to properly use them. Pickett said it would be empowering to have more than just one option.

“Microbicides would put the power of prevention into the receptive partner’s hands,” he said.

How much microbicides would cost for consumers is what Dr. Ian McGowan calls “the million dollar question.”

McGowan is a co-principal investigator at the Pittsburgh-based Microbicide Trials Network. The network is funded and run by the National Institutes of Health.

Right now, anticipated cost of the product has more to do with the price of an applicator than with the actual gel, he said. Researchers are working on a re-usable applicator that would bring down the price considerably.

The product’s power and effectiveness will be measured by how widely available it is.

“It will be important that microbicides remain as economical and affordable as possible so we can get it into the hands of people who need it,” Pickett said.

Microbicide research
Research on microbicides has been going on for more than 20 years.

The U.S. and Europe invested a combined $194 million in microbicide research in 2008, according to data from the Alliance for Microbicide Development.

The Centre for the AIDS Programme of Research in South Africa announced the first successful microbicide trial in July 2010. The clinical trial, called CAPRISA 004, used a microbicide that contained an antiretroviral drug called tenofovir. It involved HIV-negative women from South Africa.

Antiretrovirals are drugs that are currently used to treat patients with retroviruses like HIV.

The trial showed 39 percent fewer cases of HIV in women assigned to use the gel. Even though the drug did show some effectiveness in preventing HIV, it is not enough to satisfy regulators.

“The FDA demands at least two well-conducted studies showing that it is safe, effective and good quality,” McGowan said.

A parallel trial to CAPRISA 004 is now gathering participants to further test the efficacy and safety of the tenofovir microbicide. Data from both trials will be submitted to the FDA by the end of 2012.

Policy and funding
In the U.S., the three primary funders for global microbicide research are the National Institutes of Health, the United States Agency for International Development and the Bill and Melinda Gates Foundation.

The U.S. will spend about $119 million on research on AIDS vaccines and microbicides over a five period.

Microbicide research has had support at the highest levels in the U.S. Then-senator Barack Obama introduced the Microbicides Development Act in the Senate in 2007. Sen. Richard Durbin was a co-sponsor of the bill in the Senate. Then-congressman Mark Kirk co-sponsored the House version.

Christina Mulka, a spokeswoman for Sen. Durbin, said Durbin has continued to play an active role in supporting microbicide research.

“He helped lead efforts that have seen a doubling of the U.S. contribution to the Global Fund in the last four years, reaching $1.05 billion in fiscal year 2010,” Mulka said.

Representatives for Sen. Kirk could not be reached for comment.

The goal of the 2007 bill was to get better cross-department coordination and expanded resources for microbicide research and development activities at the NIH, U.S. Agency for International Development and the U.S. Centers for Disease Control and Prevention. The bill was never brought to a vote because its objectives were reached without passage.

Where do we go from here?
In 1995, 44 percent of the general public said HIV/AIDS was the most urgent health problem the nation faced. In March of 2009, only 6 percent of people felt that way, according to the Kaiser Family Foundation.

Pickett said the sense of urgency may have died down because after 1995 improved treatment meant that contracting HIV was not an immediate “death sentence.”

“I think it’s a natural thing. After we made advances in medicine that could keep people alive longer, the concern faded,” he said.

While the goal is to eventually produce vaginal and rectal microbicides for all women and men, Pickett said the priority populations are in Africa, where the epidemic is most severe.

“This is a completely different conversation than we would have had before July,” said Mitchell Warren, executive director of the AIDS Vaccine Advocacy Coalition. Although implementation of microbicides would not be seen for a number of years, focus has already shifted to proving the safety of the product.

The Food and Drug Association is responsible for regulating and approving drugs that are the product of biotechnology. But it does not have a precedent for regulating microbicides.

McGowan said the data from both the CAPRISA 004 and follow-up studies would need to be submitted to the FDA for review.

“The FDA regards this as a fast-track product, meaning it would take no longer than six months to review the dossier of information when they get it,” he said.

The secondary study is intended to end in mid-2012. The data and information would be submitted to the FDA sometime in 2013, and consumers could see a marketable product by 2014.

In order to be available in other countries, McGowan said it would have to be approved by their respective regulatory agencies. Because the results are so monumental for global health, international regulatory agencies could review the data on the same time line as the FDA, creating a product that could be distributed globally.