Safety concerns halt trials of HIV microbicide
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Microbicide gels could empower women to protect themselves from
HIV Clinical trials of a microbicide a gel or cream designed
to block the sexual transmission of HIV have been terminated
early for safety reasons, but scientists insist that this must
not hinder research into other microbicides.
Researchers announced last week (31 January) that two clinical
trials for cellulose sulphate, or ushercell, had been stopped
because one trial appeared to increase the risk of women
becoming infected with HIV.
According to the International Herald Tribune, the study that
led to stopping the trials involved 1,333 women in Benin, South
Africa and Uganda. The other trial involved 1,700 women in
Nigeria.
The Word Health Organization said the trial's failure was
"disappointing" and an "unexpected setback" in the search for
safe and effective microbicides.
Gita Ramjee, director of the HIV Prevention Research Unit of the
South African Medical Research Council, said scientists were
baffled by the trial's failure and are still trying to find the
reason for it.
She said cellulose sulphate went through rigorous laboratory and
clinical testing prior to large-scale trials and all data had
indicated it was safe.
However, Ramjee insisted that research into anti-HIV
microbicides must go on, as to do otherwise would mean "giving
up for women all over the world".
"We should continue with research but ensure that data is
reviewed more frequently, so that rapid action can be taken
should there be a cause for concern," she told SciDev.Net.
Three other microbicide compounds are currently undergoing phase
III clinical trials in Africa.
In South Africa, trials of the Carraguard microbicide are
nearing completion and results are expected by the end of 2007.
Another product, Pro2000, is being tested in South Africa,
Tanzania and Uganda. The BufferGel microbicide is being tested
in Malawi, South Africa, Zambia and Zimbabwe.
HIV specialist Jonathan Weber of Imperial College London, United
Kingdom, said there was no suggestion that other microbicides
currently being investigated, based on different chemical
compounds, have similar problems.
"There are no silver bullets in HIV prevention research. We need
a package of tools to combat the HIV epidemic, and it is hoped
that a safe and effective microbicide could be part of this
package," he told SciDev.Net.
Microbicides have gained both status and funding in the past few
years as a way for women to protect themselves against HIV
infection in situations where they have little negotiating power
to persuade male partners to use condoms.
Read more about microbicides in SciDev.Net's microbicides
spotlight:
http://www.scidev.net/dossiers/index.cfm?fuseaction=specifictopics&dossier=22&topic=171