Researchers at Albert Einstein College of Medicine of Yeshiva University have been awarded a $12 million grant from the National Institutes of Health (NIH) to develop a drug-impregnated intravaginal ring to prevent HIV infection in women.
"As we move into the fourth decade of the HIV pandemic, the disease is having its greatest impact on women, particularly in sub-Sahara Africa," said principal investigator Betsy Herold, M.D., professor of pediatrics, of microbiology & immunology, and of obstetrics & gynecology and women's health at Einstein and attending physician of pediatrics, The Children's Hospital at Montefiore.
According to UNAIDS, approximately 34 million people are living with HIV worldwide. Sub-Saharan Africa is the region most affected and accounts for 69 percent of all people living with HIV.
"To protect these women and slow the epidemic, we urgently need safe and effective prevention strategies," said Dr. Herold.
Dr. Herold and co-investigator Patrick Kiser, Ph.D., a bioengineer at the University of Utah, previously developed an intravaginal ring that delivers a potent antitretroviral drug for more than four weeks and proved highly active against HIV in laboratory studies. But learning whether the device's preclinical performance will translate into real-world effectiveness has proven difficult.
The ideal intravaginal ring must release sufficient concentrations of drug to protect women at increased risk of HIV infection. And it will contain drugs that are:
active in the vagina, cervix and rectum;
capable of both rapid and sustained drug delivery for at least one month;
effective against many different HIV subtypes;
stable without needing refrigeration.
The five-year project will determine if the drug released from the ring retains anti-HIV activity in the presence of vaginal secretions. In addition, studies involving non-human primates aimed at optimizing the vaginal ring's design will be conducted at the Centers for Disease Control and Prevention.
In tests to see if two drugs work better than one, the ring will be impregnated with a second drug that inhibits HIV through a mechanism different from the first drug. A clinical study to assess the ring's safety will also be carried out; this part of the project will include U.S. women taking oral contraceptives.
The grant will also fund a clinical study to assess safety and pharmacokinetics in women on Depo Provera in Kenya (led by Jeanne Marrazzo, M.D., M.P.H., from the University of Washington, and Nelly Mugo, M.P.H., from Kenyatta National Hospital) and in U.S. women on oral contraceptive pills (led by Marla Keller, M.D., associate professor of medicine and of obstetrics & gynecology and women's health at Einstein and attending physician of medicine at Montefiore Medical Center, the University Hospital for Einstein).
"We're optimistic that the intravaginal approach to preventing HIV infection will overcome the problem of having to remember to use oral or gel products daily and will empower women to protect themselves against HIV," says Dr. Herold.