Population Council Research that makes a difference

Breakthrough in Microbicide Research

Microbicide Gel Is Safe and Effective in Reducing Risk of HIV and Herpes Infections Among Women Participating in South African Study; Confirmatory Research Is Needed

The Road Ahead Population Council scientists are working on: Dual protection. Family planning methods like gels and rings may provide women with the option of simultaneously preventing unintended pregnancy and HIV infection. ARVs etc. Council scientists are working on both ARV-based microbicides and a candidate product with zinc to prevent HIV and other STIs transmitted vaginally and rectally. Now what? Even when an effective product is available, getting it to consumers will be challenging. Council staff are adapting lessons learned from the organization’s previous successes in introducing reproductive health products in resource-poor countries.

NEW YORK, NY (19 July 2010) — A microbicide gel containing the antiretroviral (ARV) tenofovir reduced sexual transmission of HIV infection by 39% and was 51% effective in preventing genital herpes infection among study participants, according to research conducted by the Centre for the AIDS Programme of Research in South Africa (CAPRISA). Because individuals with genital herpes are more likely to acquire and transmit the virus that causes AIDS, its prevention may also have consequences for HIV prevention. (Naomi Rutenberg discusses the results on PRI's "The Takeaway." [offsite link])

In a statement that will be made tomorrow at the XVIII International AIDS Conference in Vienna, Austria, CAPRISA leaders are also cautioning that additional research is needed to confirm these promising results.

Microbicides are products being developed to prevent the sexual transmission of HIV and other sexually transmitted infections like genital herpes when applied topically inside the vagina or rectum.

"The Population Council congratulates CAPRISA and its collaborators for this milestone in the development of microbicides," says Naomi Rutenberg, vice president and director of the Council’s HIV and AIDS program.

"This exciting news confirms our belief that microbicide development is an essential, achievable objective and encourages all of us in the field. The Population Council hopes to build on the success of CAPRISA’s study as we continue our own efforts to develop microbicide gels and rings and other HIV-prevention products."

The CAPRISA study, which started in May 2007, enrolled 889 sexually active HIV-uninfected women at two sites in South Africa. Women were randomized to one of two study groups—placebo gel with no active ingredient or tenofovir gel—and instructed to use the study product before and after sex, but not to exceed two doses in a 24-hour period, regardless of the frequency of intercourse. The trial was conducted by CAPRISA in partnership with the US-based organizations FHI and CONRAD with funding from USAID. Gilead Sciences donated the active ingredient for the manufacture of the tenofovir gel.

All participants received condoms, intensive counseling, and other routine interventions for reducing HIV risk throughout the time they were in the trial. 

Tenofovir currently is being used to treat HIV-positive individuals. This study is the first trial of this drug as a topical microbicide. Consequently, the researchers studied whether the product had an impact on the transmission of drug-resistant viruses. CAPRISA reported that no tenofovir-related drug resistance was found in the women who acquired HIV infection during study follow-up.                                                                                                                

The Population Council's approach to microbicides development is comprehensive, comprising all aspects of research, from the laboratory to clinical research, product introduction, and public education. Council researchers are developing microbicides that use antiviral drugs not used in first-line HIV therapies as well as novel compounds with different mechanisms of action. In addition to HIV prevention, Council researchers are working on products that will simultaneously protect against other sexually transmitted infections and pregnancy. Complementary research is being conducted to increase adherence to product use and improve clinical trial design.

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About the Population Council
The Population Council confronts critical health and development issues—from stopping the spread of HIV to improving reproductive health and ensuring that young people lead full and productive lives. Through biomedical, social science, and public health research in 50 countries, we work with our partners to deliver solutions that lead to more effective policies, programs, and technologies that improve lives around the world. Established in 1952 and headquartered in New York, the Council is a nongovernmental, nonprofit organization governed by an international board of trustees.

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