U.S. grant to Pitt may alter AIDS battlefield

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A vaginal ring that prevents both AIDS and pregnancy with one device? A rectal gel that kills HIV, the virus that causes AIDS?

These may be the next frontier in the global fight against AIDS, and both are being developed by a program based at the University of Pittsburgh and Magee-Womens Research Institute that has just secured $70 million from the National Institutes of Health.

Researchers say the work has the potential to revolutionize AIDS prevention in the same way that Jonas Salk's vaccine prevented polio, putting Pittsburgh in the forefront of another worldwide public health advancement.

The funding, to be disbursed over seven years, will support an already extensive program at Pitt called the Microbicide Trials Network, which does clinical trials with partners in 31 countries on four continents, including Africa, where AIDS is alarmingly common.

The network has completed 13 trials since 2006 and has 11 more underway. It is also planning to design and implement several additional studies with the new funding.

Microbicides are products designed to kill the microbes that carry the AIDS virus. They are applied inside the vagina or rectum to prevent sexual transmission of AIDS.

Sharon Hillier, co-principal investigator and a professor at the Pitt School of Medicine, said that despite huge progress in fighting AIDS over the past decade, "Two groups continue to have high rates of new HIV infection -- young women and men who have sex with men."

The network's focus is to target their unmet needs, although any advancements will have major implications for all sexually active people.

"Ultimately, we want to identify a lubricant-like product that both men and women can use to protect themselves from acquiring HIV during anal sex," said her colleague, Ian McGowan, co-principal investigator and professor at the Pitt School of Medicine.

Vaginal rings, being tested in 2,300 women, are inserted in the vagina by health workers at a clinic so that women don't have to negotiate the use of condoms by their male partners. Efforts are also underway to combine contraceptives with the microbicide, thus accomplishing two preventive goals in one device.

The study is testing the long-term safety and efficacy of the rings, which slowly release the drugs over the month. They are replaced monthly.

"Women seem to like using the ring, they find it easy to use," said Ms. Hillier, who holds Ph.D.s in bacteriology and public health.

"I think it's going to revolutionize women's health. It will give them the power to control their own exposure risk in one simple product."

Also being tested is a microbicide gel for the rectum, mainly to prevent AIDS in men and transsexuals who have anal sex with men, but ultimately for use by women, too.

Dr. McGowan said that research is taking place in three phases -- daily use, use before and after sex, and an oral tablet. At two of the test sites, Pittsburgh and Thailand, volunteers give tissue samples to see if they resist the virus.

The studies are double-blind, randomized trials, so results are not available until completion, Ms. Hillier said, but researchers and the NIH have high hopes for effectiveness.

With all the rapid advancement in biomedical technology, Dr. McGowan said, it's an exciting time for AIDS prevention. "We have invited a number of collaborators to suggest new products, so the possibilities are expanding all the time."

"There has been so much technological advancement in treatment," added Ms. Hillier. "This is the other side of the coin. It's clear that we cannot treat our way out of this epidemic. We need bold approaches to stop the spread. Condoms alone are not enough."

Sally Kalson: skalson@post-gazette.com or 412-263-1610.


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