The first vaginal gel designed to protect women from the AIDS
virus, though safe, did not prevent infection in a study of 6,000
South African women, researchers said on Monday.
The study was marred by low use of the gel, which could have
undermined results, the researchers 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.
The product, called Carraguard, is the first HIV cream to be
tested in advanced trials in women and shown to be safe, raising
hopes that it might be combined with drugs or other compounds to
work better.
"We are disappointed that this trial did not show Carraguard to
be effective; nonetheless the completion of this trial is a
milestone in HIV prevention research," said Peter Donaldson,
president of the New York-based Population Council, which sponsored
the trial.
Carraguard, a microbicide developed by the nonprofit Population
Council contains carrageenan, which comes from seaweed and is
widely used in the food and cosmetics industries. 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, all in South Africa.
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.
"The results are comparable," with no statistically significant
difference, said Khatija Ahmed, a microbiologist who headed the
study's Setshaba Research Centre site near Pretoria.
However, women in the study used the gels only 44 percent of the
time, and some used it hardly at all. Researchers are still
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.
(Agencies via Xinhua News Agency February 19, 2008)