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MICROBICIDE TRIALS NETWORK

FOR IMMEDIATE RELEASE

TWELVE INSTITUTIONS IN AFRICA, INDIA AND U.S. NAMED BY NIH AS
CLINICAL TRIAL UNITS FOR THE MICROBICIDE TRIALS NETWORK

Studies looking at microbicides for HIV prevention in women will take
place at 17 sites in seven countries

PITTSBURGH, March 12 – Twelve institutions today were named by the
National Institute of Allergy and Infectious Diseases (NIAID), part
of the National Institutes of Health (NIH), as HIV/AIDS clinical
trial units (CTUs) for the Microbicide Trials Network (MTN), a new
HIV/AIDS clinical trials network established by NIAID last year. The
CTUs, located in Africa, India and the United States, will engage in
multi-center studies spanning 17 locations in seven countries that
seek to determine if topical microbicides can help prevent the sexual
transmission of HIV in women.

Nearly half of the 39.5 million people living with HIV/AIDS are
women, and in Africa, women account for 59 percent of all infected
adults. Young women are especially vulnerable. For instance, in sub-
Saharan Africa, those aged 15 to 24 with HIV outnumber men of the
same age by three to one.

In developing countries, HIV most often is spread through unprotected
heterosexual intercourse, and educational efforts promoting
abstinence, monogamy, and condoms have not been completely effective.
Through its CTUs, the MTN is evaluating the potential that
microbicides, substances formulated as gels or creams, for example,
can reduce or prevent the sexual transmission of HIV and other
sexually transmitted diseases when applied topically to the surface
of the vagina.

The MTN CTUs based outside the United States are the National AIDS
Research Institute in Pune, India; the Medical Research Council in
Durban, South Africa; and the University of Cape Town, South Africa.
U.S. institutions named as CTUs that will be conducting MTN trials
exclusively at the international sites with whom they collaborate are
the University of California, San Francisco, which operates in
Zimbabwe, and Johns Hopkins Bloomberg School of Public Health and
Johns Hopkins School of Medicine, both in Baltimore, with
affiliations in Malawi and Uganda, respectively. The University of
Alabama at Birmingham, was granted two CTU awards, one for its
international site in Zambia, and the second for its U.S. site.

The remaining CTUs, all U.S.-based, are Case Western Reserve
University in Cleveland; Columbia University in New York City, the
University of Pittsburgh; and the University of Pennsylvania,
Philadelphia.

Each of these CTUs has affiliated clinical research sites that will
conduct the actual trials, some within the same city or institution
and others at additional locations in the same country or region.
Accounting for those CTUs with more than one clinical research site,
the MTN will be conducting trials at 17 locations in five African
countries, the United States and India.

The MTN's clinical research sites are located in Pune, India;
Llongwe, Malawi (two sites); Durban, South Africa (four sites); Cape
Town, South Africa; Kampala, Uganda; Harare, Zimbabwe (two sites);
and Lusaka, Zambia; as well as in New York, Cleveland, Pittsburgh,
Philadelphia and Birmingham, Ala.

To face the global urgency of the HIV/AIDS epidemic head-on, the MTN
anticipates conducting 17 scientifically rigorous and ethically sound
clinical trials over the next seven years. Some of these trials will
be designed to evaluate microbicides along with other promising
HIV/AIDS prevention approaches, such as oral anti-retroviral
prophylaxis.

"The scope of the crisis requires an aggressive agenda in which the
clinical trial units and clinical research sites play an essential
role. By virtue of being selected by NIH, our CTUs have proved
themselves as the most qualified and the most committed to take part
in an endeavor of such great global importance," said Sharon Hillier,
Ph.D., MTN principal investigator and professor of obstetrics,
gynecology and reproductive sciences and of molecular genetics and
biochemistry at the University of Pittsburgh School of Medicine and
director of reproductive infectious disease research at the Magee-
Womens Research Institute.

The MTN brings together international investigators and community
partners who are devoted to reducing the sexual transmission of HIV
through the development and evaluation of microbicides and who work
within a unique infrastructure designed to conduct research that will
support licensure of topical microbicide products for widespread use.

Based at the University of Pittsburgh and Magee-Womens Research
Institute, MTN's core operations are supported by a central
laboratory at the University of Pittsburgh, a statistical and data
management center housed within the Statistical Center for HIV/AIDS
Research & Prevention at the Fred Hutchinson Cancer Research Center,
and Family Health International, a global organization with expertise
conducting clinical protocols. It receives funding from three NIH
institutes: NIAID, the National Institute of Mental Health and the
National Institute of Child Health and Human Development.

MTN's 12 CTUs are among the 60 U.S. and international institutions
that recently received awards from the NIAID; NIAID expects to fund a
total of 73 CTUs with approximately 145 clinical research sites
within the next several months. Each CTU and clinical research site
will work with one or more of six NIAID HIV/AIDS clinical trials
networks. In addition to the MTN, they include the AIDS Clinical
Trials Group, the HIV Prevention Trials Network, the HIV Vaccine
Trials Network, the International Maternal Pediatric Adolescent AIDS
Clinical Trials Network and the International Network for Strategic
Initiatives in Global HIV Trials.

For additional information about the HIV/AIDS clinical trials units,
see http://www3.niaid.nih.gov/news/QA/CTU07QA.htm . A complete
listing of the newly funded CTUs and clinical research sites are
available at

http://www3.niaid.nih.gov/about/organization/daids/Networks/daidsnetwo
rkunits.htm.

For more information about MTN, go to www.mtnstopshiv.org.