New Female HIV Gel Shows Some Promise

A new study labeled HPTN 035 has shown that a new vaginal gel designed to help prevent HIV infection in females is demonstrating some promising signs in a trial study done in both the United States and Africa. The study was funded by the NIAID (National Institute of Allergy and Infectious Diseases) and presented this past February at the Conference on Retroviruses and Opportunistic Infections.

The new trial microbicide gel (PRO 2000 manufactured by Indevus Pharmaceuticals, Inc) was deemed safe and close to 30% effective. Of the many studies done on various HIV-related drugs, this was the first study done that demonstrated that a microbicide (any foam, cream or gel applied within the vaginal walls or inside the rectum that is designed to help prevent the transmission of HIV or other STDs) could possibly prevent male-to-female sexual transmission of HIV. Anthony Fauci, the director of NIAID, states, “Although more data are needed to conclusively determine whether PRO 2000 protects women from HIV infection, the results of this study are encouraging. An effective microbicide would be a valuable tool that women could use to protect themselves against HIV and one that could substantially reduce the number of new HIV infections worldwide,”

Salim Abdool Karim who works for the Center for the AIDS Program of Research in South Africa, adds, “The study, while not conclusive, provides a glimmer of hope to millions of women at risk for HIV, especially young women in Africa. It provides the first signal that a microbicide gel may be able to protect women from HIV infection.” Globally, approximately 50% of those infected with HIV are women; however, in many southern countries in Africa, women are often three times more likely to be infected with HIV than men. Creating and distributing a microbicide that is effective would be very promising to women in these regions, especially since it is a prevention method they would be responsible for. In a region where many women have no choice or voice when it comes to sex or condom use, this would put some power in their own hands.

Over 3,000 women in both the United States and Africa participated in this study that started in 2005 and lasted just under two years. Two microbicide gels were tested. The first, PRO 2000 actually helps prevent HIV from entering into cells. The second, BufferGel (manufactured by ReProtect Inc.), makes the vaginal environment more acidic when semen is present, thus helping, hopefully, to make HIV inactive. The women were divided into four groups, some using BufferGel, some using PRO2000, some using a placebo gel and the rest not using any type of gel before sexual activity. Each woman was given safe sex material, free condoms and free testing for STDs while the study went on. 81% of the participating women reported using the gels regularly and close to 100% stated they would use the gels if they were deemed appropriate for HIV prevention in the future. Close to 75% used condoms during the trial.

By the end of the trial, 194 women tested HIV-positive. 36 of these were using PRO2000, 54 were using BufferGel, 51 were using the placebo gel and 53 did not use any type of gel. Roberta Black, a division chief in NIAID, stated, “Although a statistically significant protective effect was not observed, HPTN 035 successfully met its goal of determining whether either of the two candidate microbicides had sufficient promise to be considered for testing in a larger Phase III clinical study.”