15 June 2011
After encouraging results on a pioneering vaginal gel which reduces the risk of HIV and genital herpes infection, South Africa, in partnership with the United States, has launched a follow-up study to test the safety of the gel.
The Phase III trial, to be known as FACTS 001, will be conducted by the Follow-on African Consortium for Tenofovir Studies (FACTS) led by Professor Helen Rees, director of the Wits Reproductive Health and HIV Institute (WRHI). It is expected to start by the end of July and run for 24 months.
The study prior to this, known as CAPRISA 004, was conducted last year by the Centre for the Aids Programme of Research in South Africa (Caprisa) on nearly 900 women in KwaZulu-Natal.
It showed that the use of the gel containing the antiretroviral drug tenofovir reduced HIV infection by 39 percent and also reduces the risk of contracting genital herpes by 51 percent.
However, CAPRISA 004 was a relatively small trial (Phase IIb trial) and was not designed for licensure purposes.
On Tuesday, South Africa’s Department of Science and Technology, in partnership with the United States, launched FACTS 001, which will test the safety and effectiveness of 1 percent tenofovir gel.
FACTS 001 will be a bigger study than CAPRISA 004, involving 2 200 women aged 18 to 30 years at seven trial sites across South Africa.
Giving power to women
Speaking at the launch of FACTS 001, Deputy Science and Technology Minister Derek Hanekom said the government was looking forward to this stage of the trial, and was very proud of the collaboration between the South African government and United States.
He noted that while people should continue to condomise and be faithful, and while research for vaccines should continue, once the results regarding the gel were positive and confirmed, it would be possible to help protect women against HIV/Aids.
“This product does something different: it gives women the power to negotiate and make decisions for themselves,” Hanekom said. “It needs to be done. We are ready, and if it confirms its effectiveness, we will soon put it on the market, combined with the roll-out of the treatment.”
Professor Rees said the research so far had found that using the gel before and after sex provided moderate protection against HIV and Herpes Simplex.
“The establishment of the FACTS consortium to confirm the effectiveness of the first vaginal microbicide gel for women and enable licensure is extremely exciting for South African researchers,” Rees said. “The objectives of the FACTS 001 confirm the CAPRISA 004 results in larger more diverse populations.
“The South African government’s support for FACTS demonstrates a new era of collaboration between researchers and government with the common vision of preventing HIV infections in women.”
The government had funded the trial with an amount of R17-million for a three-year period.
United States Ambassador Donald Gips commended the South African government for its decision to fund the FACTS study and partnering with the US, which has pledged to fund the study for R129-million for a three-year period.
“The study offers a new tool to prevent HIV/Aids,” Gips said. “We have to figure out how to prevent more people from being infected with the disease. It is very urgent for the researchers to complete the trial for its approval, because protecting women and girls from contracting the disease is very crucial.
“We are committed to empowering women and girls to protect themselves by finding new HIV prevention options,” Gips said.
“Confirming tenofovir gel’s effectiveness is a fundamental and essential step in the right direction. Together, government and civil society are making strides to slow down the infection, and the US is very proud to support you.”