Anti-HIV gel leadership team acknowledged for outstanding achievement in world health
CHICAGO, IL — 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:
- Dr. Salim S. Abdool Karim, Director, CAPRISA and Pro Vice-Chancellor, University of KwaZulu-Natal
- Dr. Quarraisha Abdool Karim, Associate Scientific Director, CAPRISA and Associate Professor, Columbia University
- Dr. Henry Gabelnick, Executive Director, CONRAD
- Dr. Ward Cates, President, Research, FHI
- Dr. James Rooney, Vice President of Medical Affairs at Gilead Sciences
- Dr. Carl Montague, General Manager of Health at the Technology Innovation Agency (TIA)
- Dr. Jeff Spieler, Senior Technical Advisor in Science and Technology in Population and Reproductive Health (PRH) at USAID
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.