UNAIDS and the World Health Organization have agreed to hold two further clinical trials on a vaginal gel, which shows promise in reducing the risk of HIV. Experts attending a meeting in Johannesburg, South Africa last week decided new trials should be conducted as quickly as possible to confirm preliminary hopeful results.
Results of the first study on the vaginal gel created a lot of excitement when they were presented at the International AIDS Conference in Vienna in July.
Chief Scientific Adviser to UNAIDS, Catherine Hankins says the gel was found to be 39 percent effective in protecting women from getting infected with HIV.
And, she says, the women who were using the gel more than 80 percent of the time they were having sex, had a 54 percent protection. "So, this was the first time ever that we have seen a positive result for a microbicide gel, which is a women initiated, women controlled product. So, the concern was how to rapidly move to make this product available to women. And, the results of the meeting were a consensus that two confirmatory trials were needed. And, these needed to get up and running very, very quickly," she said.
Dr. Hankins explains every day that goes by, in which the gel is not available to women, about 2,500 more women get infected with HIV.
The World Health Organization reports about half the people living with HIV in the world are women. In sub-Saharan Africa, WHO says more women are infected than men. HIV is a major cause of maternal mortality.
Dr. Hankins says one of the new clinical trials will take place primarily in South Africa. Sexually active 16 and 17 year olds will use the gel 12 hours before sex and once during the 12-hour period after sex to test its safety and efficacy against HIV.
She says the second study will be conducted in other African countries. It will test if a single application of the gel before sex or immediately after sex, is as effective and safe as taking two doses.
During the original trial, she says women were told to use condoms along with the gel when they had sex, to lower the risk of infection. But, she notes there are times when using a condom is not desirable.
"When you are trying to get pregnant. When you are not seeing your guy very often, it is obvious you need some other mechanism. When we eventually market this, this will be marketed as something to be used with condoms and encourage male circumcision as well. All the methods need to be used in combination. That is why our basic message is combination prevention," Hankins said.
Nearly 20 years of research have gone into microbicides. If confirmed, advocates say the tenofovir gel would empower women and allow them to protect themselves from HIV without requiring the cooperation of their male partner.
The first trials are likely to get under way early next year. The next phase of the research is estimated to cost $100 million.
