WUNRN
HIV/AIDS - Female Vaginal
Microbicide Found
Ineffective for HIV/AIDS
Prevention in Trials to Date
Reuters
- 14 December 2009
*
AIDS gel proves ineffective in largest trial to date
*
Scientists say results disappointing but definitive
LONDON,
Dec 14 (Reuters) - A gel made by U.S. drug firm Endo Pharmaceuticals
<ENDP.O> that is designed to prevent infection with the AIDS virus has
proved ineffective in trials in Africa, Britain's Medical Research Council said
on Monday.
A
large international trial of the vaginal microbicide, Pro 2000, in more than
9,000 women in four African countries found no evidence that it reduces the
risk of HIV infection.
To
date no gel microbicide has been shown to be effective against HIV infection
and this trial showed conclusively that PRO 2000 gel was of no added benefit,
ending scientific speculation about its clinical importance, the MRC said in a
statement.
"This
result is disheartening, particularly in light of the results of a smaller
trial sponsored by the US National Institutes of Health (NIH) which suggested
that PRO 2000 could reduce the risk of HIV infection by 30 per cent," said
Sheena McCormack of the Medical Research Council, who led the trial.
"Nevertheless
we know this is an important result and it shows clearly the need to undertake
trials which are large enough to provide definitive evidence for whether or not
a product works."
The
MRC's trial was the largest international clinical trial to date into a
preventative HIV gel. It took place between September 2005 and September 2009
involved 9,385 women and was carried out by the Microbicides Development
Programme (MDP), a not-for-profit partnership of 16 African and European
research institutions.
The
trial found that the risk of HIV infection in women who were given PRO 2000 gel
was not significantly different than in women supplied with a placebo gel.
Jonathan
Weber of the MDP said the result was disappointing but added: "The trial
itself was very well designed and undertaken, so we know that the results are
definitive.
"It
is unfortunate that this microbicide is ineffective at preventing HIV infection
but it's still vital for us as scientists to continue to look for new ways of
preventing HIV," he said in a statement (Reporting by Kate Kelland;
Editing by Greg Mahlich)
________________________________________________________________________
Statement from the Population Council
Trial Finds Microbicide Ineffective
as HIV Prevention Method for Women
NEW YORK, NY (14 December 2009) — The
Population Council is disappointed that the microbicide candidate PRO 2000 was
not shown to be effective. We applaud the Microbicides Development Programme;
the researchers in four countries who conducted and completed the largest
microbicide trial to date; and the 9,385 volunteers who made it possible. It is
encouraging that these results confirm the safety of PRO 2000. The biomedical
and behavioral information generated by this trial will advance the field and
inform future research.
We continue to believe that microbicide
development is an essential, achievable objective. An effective vaginal
microbicide would increase women’s prevention options, saving lives and slowing
the progress of the AIDS epidemic.
Because no one product can meet the needs of
everyone, those of us working in HIV prevention will continue to develop
products and test approaches to expand the means for women and men to protect
themselves.
The Population Council is committed to
developing a range of microbicides as part of our comprehensive approach to HIV
prevention, support, and treatment
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