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FACTBOX - Trial shows an AIDS gel can protect women

South Africa, July 20:  A trial of women in South Africa shows that a gel made using Gilead Sciences Inc’s HIV drug tenofovir lowered the rate of HIV infections in women by 39 percent over two and a half years.


It is the first trial to show a microbicide might protect women from the deadly and incurable virus, which has killed 25 million people since the AIDS pandemic started in the 1980s and which infects 33 million today.

Here are some facts about the trial:

* The trial was run by the Centre for the AIDS Programme of Research in South Africa or CAPRISA at the University of KwaZulu-Natal in Durban, South Africa.

* It enrolled 889 South African women aged 18 to 40 who were HIV-negative, sexually active, and at high risk of becoming infected with HIV.

* All were given packets of applicators filled with gel and told to insert one dose up to 12 hours before sex and a second no more than 12 hours afterwards.

* Half the women got placebo gels and half received gels containing a very low dose of tenofovir, an inexpensive HIV drug.

* At the end of the study 422 women remained in the tenofovir arm and 421 in the placebo arm, a retention rate of 95 percent, which suggests the gel was not unpleasant to use.

* At 30 months, 98 women were infected with HIV -- 38 of them had been given tenofovir and 60 were on placebo. This is a 39 percent reduction in HIV incidence for tenofovir.

* At 12 months into the study, women who got tenofovir were 50 percent less likely to be infected than women who got placebo.

* 54 of the women became pregnant and delivered 31 babies. None had any congenital problems and the miscarriage rate was normal.

* Blood tests showed the tenofovir stayed in the vagina and did not cause effects elsewhere in the body. This suggests side-effects will be low and also suggests that women who become infected with HIV will still be able to take pills without being resistant to their effects.

* In a surprise finding, researchers said the gel also reduced the risk a woman would get genital herpes by 51 percent.

* The main side-effect was slightly more mild diarrhea in the women who got tenofovir.


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