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Microbicides: The future of HIV/AIDS Prevention?
LONDON, England, April 12, 2002 — PSI/Europe, PSI's European partner
based in London, is a member of a consortium that has recently been
awarded £16.5 million ($23.6 million) by the British Department
for International Development for a five-year project exploring the
potential for a microbicide in the fight against HIV/AIDS.
What are microbicides?
A microbicide is a compound that could be applied vaginally or anally,
prior to intercourse, in order to protect against HIV and other sexually-transmitted
infections (STIs). Researchers have been working on them for at least
15 years. Some 60 potential compounds have been identified and 3-4 are
ready for Phase III clinical trials. They could be formulated as a gel,
film, sponge or pessary. They could have contraceptive effects or not.
They are believed to protect both men and women. Although in theory
they could be used anally, the current products have not been tested
for safety in anal use.
The Microbicides Development Programme (MDP)
Partners in the MDP include research institutes in South Africa, Zambia,
Uganda, Tanzania and Cameroon; economists and modellers at the London
School of Hygiene and Tropical Medicine; scientists at universities
in the U.K.; and biotechnology companies in the U.K. and U.S. The consortium
is led by the Medical Research Council of the U.K. Major activities
will include:
- Further development, screening and safety trials of candidate products;
- Phase II and III trials of promising products, with associated acceptability
research;
- Modelling and economic analysis; and
- Prospective market research.
The first two compounds to be tested under the MDP are Pro2000 (developed
by Interneuron Pharmaceuticals in the U.S.) and dextrin sulphate
(or Emmelle, developed by ML Laboratories in the U.K.). Starting some
time in 2003, hundreds of volunteer women at each of seven sites in
Africa will be given one or other of the candidate products or a placebo
for use over 12-18 months. HIV incidence will be measured in each of
the study populations to determine the effectiveness of the products.
Related initiatives
Last year, studies were conducted by Family Health International and
others in Cameroon. They studied the effectiveness of high doses of
Nonoxynol 9 (N-9), a compound that has long been used as a spermicide
and that had been found to have virucide properties in lab tests. Unfortunately,
the trial was abandoned because under high intensity use it was found
to irritate the vagina and thereby increase HIV transmission.
The Population Council plans to conduct phase III trials of Carraguard,
the active ingredient of which is derived from seaweed and has long
been used safely for other purposes. Later this year Population Council
will begin phase III clinical trials that are expected to last several
years at sites in Africa. Other products are also likely to go to phase
III trials in the coming year or two.
PSI/Europe's role
PSI/Europe has been included in the MDP in order to bring a marketing
perspective to the acceptability research and to anticipate mass marketing
strategies. PSI/Europe has three broad roles:
- To enrich the social science research that will take place around
the phase III trials with the perspectives of market research. Social
scientists will be studying user attitudes to the products, their
likes and dislikes, the product's impact on gender relationships in
different kinds of partnerships, its role in the overall method mix,
and user preferences. PSI/Europe will add concepts and approaches
from market research: treating users as consumers rather than beneficiaries
or patients, attempting to assess demand and willingness to pay, exploring
alternative product positioning strategies, etc.
- On the basis of acceptability research conducted largely by others,
PSI/Europe will develop prospective marketing analyses and strategies
and speculate, based on marketing experience with analogous products,
as to the effects of alternative positioning strategies (and associated
packaging, pricing, distribution and promotion strategies) on levels
and profiles of consumer demand. Following phase III trials PSI/Europe
will be in a position to recommend product features to be tested in
future formulations. For example, a spermicide may be a better positioning
than a lubricant, or both if these may appear to be more in line with
consumer needs than a microbicide positioned alone.
- Finally, PSI/Europe may be able to offer other kinds of assistance
to the trials. For ethical reasons, all trial participants will receive
AIDS education and condom promotion: PSI affiliates may be able to
provide product samples and promotional materials, or even to conduct
some sessions. Here may also be some potential for the researchers
to benefit from data generated in PSI surveys.
— Guy Stallworthy, Executive Director, PSI/Europe
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