- The Washington Times - Tuesday, February 19, 2008

The first anti-AIDS vaginal gel to make it through late-stage testing failed to stop HIV infection in a study of 6,000 South African women, disappointed researchers announced yesterday.

The study was marred by low use of the gel, which could have undermined results, they said. Women used it less than half the number of times they had sex, and only 10 percent said they used it every time as directed.

Scientists still are analyzing the results to see whether this made a difference. They also plan more tests on a revamped gel containing an AIDS drug that they hope will work better.

The gel used in the study did prove safe, however, and researchers called that a watershed event.

For now, the effort is the latest disappointment in two decades of trying to develop a microbicide, a cream or gel women could use to lower their risk of getting HIV through sex. A female-controlled method is especially needed in poor countries where women often can’t persuade men to use condoms.

A year ago, scientists stopped two late-stage tests of a different gel after early results suggested it might raise the risk of HIV infection instead of lowering it.

The new study tested Carraguard, a microbicide developed by New York-based nonprofit Population Council. It contains carrageenan, which comes from seaweed and is widely used in the food and cosmetics industries as a gel, stabilizer and thickening agent. Lab, animal and early human tests suggested it might prevent HIV and other sexually spread infections.

The latest study was done from March 2004 through March 2007 in Gugulethu, Isipingo and Soshanguve.

More than 9,000 women, average age 31, volunteered for the study. About 27 percent tested positive for HIV and were disqualified. In all, 6,202 women were randomly given either Carraguard or a placebo gel. Neither the women nor the study staff knew who received what. All received safe-sex counseling and condoms.

Women participated from nine months to two years, with 4,244 completing the study. About 18 percent dropped out, often because they became pregnant and the gel is not known to be safe for use in pregnancy. Another 13 percent could not be found for follow-up information.

At the end of the study, there were 134 new HIV infections in the Carraguard group and 151 in the fake gel group — a rate of 3.3 infections per 100 women each year in the microbicide group and 3.7 for the placebo group.

However, women in the study used the gels only 44 percent of the time, and some used it hardly at all.

Researchers are analyzing the numbers to see what that means. If nonuse was far greater in the microbicide group than the placebo group, “it could have had an impact on our final study results,” said Barbara Friedland, the study’s behavioral coordinator.

The study was paid for by the Bill & Melinda Gates Foundation and the U.S. Agency for International Development.

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