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PUBLIC RELEASE DATE:
20-Jun-2011

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Contact: Annette Larkin
larkinannette@yahoo.com
703-772-6427
CONRAD

Anti-HIV gel leadership team acknowledged for outstanding achievement in world health

Chicago, IL USA--June 20, 2011--Today the CAPRISA 004 study leadership team is being awarded the inaugural Drug Information Association (DIA) President's Award for Outstanding Achievement in World Health. The award recognizes the team's significant contribution to the field of HIV prevention and is being presented during the opening plenary of the annual DIA conference. The CAPRISA 004 study demonstrated the effectiveness of tenofovir 1% gel in reducing the risk of HIV and herpes infection in women.

"The CAPRISA 004 trial provides new hope for women who bear the brunt of the HIV epidemic in Africa. When implemented, it could have a profound impact on the course of this epidemic," said Study Co-principal Investigator Dr. Salim S. Abdool Karim, Director of CAPRISA and Pro Vice-Chancellor (Research) of the University of KwaZulu-Natal, South Africa. "This breakthrough would not have been possible without the close collaboration between the three South African and the three U.S. partners who led this study; I am proud and honored to receive this award on behalf of this remarkable team."

The Center for the AIDS Program of Research in South Africa (CAPRISA) of the University of KwaZulu-Natal and Columbia University spearheaded the trial in partnership with FHI and CONRAD, with the support of USAID, and the South African government through the Technology Innovation Agency (TIA). Gilead Sciences donated the active ingredient for the manufacture of the gel.

"We are pleased that the DIA has recognized the CAPRISA team's outstanding achievement and significant contribution to the fields of microbicide research and HIV prevention," said Howard Jaffe, M.D., President and Chairman of the Board of the Gilead Foundation. "Gilead congratulates the principal investigators, study staff and partners, and commends the courageous women who participated in this historic trial."

The CAPRISA 004 study of tenofovir gel involved 889 women at two sites in KwaZulu-Natal, South Africa. Women in the study were advised to use the gel up to 12 hours before sex and again soon after having sex, for a maximum of two doses within 24 hours. Women using the gel with the active ingredient had an average of 39% fewer HIV infections and 51% fewer genital herpes infections compared to women who used a placebo gel. These results provided the first evidence that an antiretroviral drug can reduce the risk of HIV in women.

"USAID made the right decision in supporting the CAPRISA 004 trial. We were thrilled to collaborate with the South African government in funding the study and we continue to work

closely with a wide range of partners in planning for all of the aspects of implementation as we await the results of confirmatory trials," said Dr. Jeff Spieler, Senior Technical Advisor in Science and Technology in Population and Reproductive Health (PRH) at USAID.

The CAPRISA 004 study leadership team includes:

Tenofovir gel is currently being fast-tracked for approval by the FDA and other regulatory bodies, contingent upon the results of an on-going confirmatory trial. TIA and CONRAD recently signed a license agreement that grants TIA the rights to manufacture and distribute tenofovir gel in Africa to ensure that women in South Africa will have immediate access to the gel, once approved. The gel will be registered, manufactured and distributed by ProPreven, a joint venture involving TIA, Cipla Medpro and iThemba Pharmaceuticals.

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CAPRISA (www.caprisa.org) is an AIDS research institute of the University of KwaZulu-Natal and Columbia University. Its headquarters are at the Nelson R Mandela School of Medicine, University of KwaZulu-Natal in Durban, South Africa. CAPRISA is a designated UNAIDS Collaborating Centre for HIV Prevention Research. The main goal of CAPRISA is to undertake globally relevant and locally responsive research that contributes to understanding HIV pathogenesis, prevention and epidemiology, as well as the links between tuberculosis and AIDS care. CAPRISA comprises four research programmes: HIV pathogenesis & vaccines, HIV and TB treatment, Microbicides, and HIV prevention and epidemiology.

CONRAD (www.conrad.org) was established in 1986 and is a Division of the Department of Obstetrics and Gynecology at Eastern Virginia Medical School (EVMS) in Norfolk, VA, where it has laboratories and a clinical research center. The main office is located in Arlington, VA with additional offices in West Chester, PA and collaborators around the world. CONRAD is committed to improving reproductive health by expanding the contraceptive choices of women and men and by helping to prevent the transmission of HIV/AIDS and other sexually transmitted diseases. CONRAD provided the gel formulation of tenofovir for the CAPRISA 004 trial.

FHI (www.fhi.org) is a global health and development organization whose rigorous, science-based approach builds programs that create lasting change. Founded in 1971, FHI maintains offices and staff worldwide, helping to forge strong local relationships that enable us to make measurable progress against disease, poverty, and inequity--improving lives for millions. FHI provided scientific and operational expertise to the South African scientists in the CAPRISA 004 trial.

Gilead Sciences (www.gilead.com) is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. Gilead's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.

Technology Innovation Agency, formerly known as LIFElab (www.tia.org.za) TIA was formed from a merger of several Department of Science and Technology-funded instruments, including LIFElab. TIA is mandated to stimulate and intensify technological innovation in order to improve economic growth and the quality of life of all South Africans by developing and exploiting technological innovations. To this end, TIA is set up to be a world class innovation agency that supports and enables technological innovation to achieve socio-economic benefits for South Africa through leveraging strategic partnerships.

USAID (www.usaid.gov) is an independent federal government agency that receives overall foreign policy guidance from the Secretary of State. With headquarters in Washington, D.C., USAID's strength is its field offices around the world. We work in close partnership with private voluntary organizations, indigenous organizations, universities, American businesses, international agencies, other governments and other U.S. government agencies. USAID has working relationships with more than 3,500 American companies and over 300 U.S.-based private voluntary organizations.



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