||Gabriel ADEYEMO [ profile ]
New test phase of HIV gel launched----We are definitely movingforward with Tenofovir gel
Jun 18th, 2011 - 19:28:08
AUTHOR: Gabi Khumalo
Fellow GYCAers, we are surely moving forward with the good news on
prevention sciences, treatment, care and support.
After encouraging results on a vaginal gel containing the antiretroviral
drug tenofovir, which reduces HIV infection and risk of contracting genital
herpes, a follow-up study to test the safety of the gel has been launched.
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, who is the 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 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
On Tuesday, the 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. Speaking at the launch of FACTS 001, Deputy
Minister of Science and Technology, Derek Hanekom, said 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 of
America. He noted that while people should continue to condomise and be
faithful, research for vaccines also have to continue, adding that once the
results are positive and confirmed, it would make it possible to help
protect women against HIV and Aids. "This product does something different,
it gives women the power to negotiate and make decisions for themselves. 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,"
Hanekom said. The department had funded the trial with an amount of R17
million for a three-year period.
Professor Rees said the research 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. 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," said Rees.
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 and Aids. 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,"
Gips said. "We are committed to empowering women and girls to protect
themselves by finding new HIV prevention options.
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
Click on the above link for more stories on this newly launched phase 3
Yours' in Prevention Science
Regional Focal Point - West Africa
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