First Multipurpose Gel Designed to Prevent HIV, HSV, and HPV Simultaneously in Women and Men Advances in Clinical Trials

June 21, 2018—A new Phase I study of the Population Council’s multipurpose prevention technology (MPT) gel PC-1005, launching this week, will examine the safety of the gel when used rectally by both men and women. If proven effective, PC-1005 gel would be the first product to prevent three incurable sexually transmitted infections (STIs)—HIV, herpes simplex virus (HSV), and human papillomavirus (HPV)—when used either vaginally or rectally.

The new rectal safety study of PC-1005 gel, to be conducted by the Microbicide Trials Network (MTN) and funded by the U.S. National Institutes of Health, will be known as MTN-037. The study will enroll approximately 12 HIV-uninfected men and women at two sites in the United States. In an effort to study the gel as broadly as possible, the trial will be open to both cisgender and transgender participants. The study builds on positive results from a recent phase I study that looked at vaginal use of the gel.

“Addressing the global health crisis of STIs is a cornerstone of improving sexual and reproductive health for women and men worldwide,” said Tom Zydowsky, Population Council director of biomedical research and pharmaceutical development, HIV and AIDS. “Viral STIs such as HIV, HSV, and HPV cause life-threatening illness and create a huge burden on health systems, especially in low-income countries. If proven effective, an MPT gel such as PC-1005 could contribute significantly to efforts to curb these incurable viral STIs.”

PC-1005 gel, also known as MZC gel, contains three key ingredients that provide broad-spectrum antiviral activity:

• MIV-150, a highly potent antiretroviral drug that is effective against HIV;
• Zinc acetate, an antiviral compound that protects against HIV and HSV; and
• Carrageenan, a seaweed-derived compound that is among the most potent anti-HPV agents identified to date.

Worldwide, an estimated 1.8 million people are infected with HIV annually, and more than a million people contract STIs every day. HIV can cause serious illness or death, especially for the millions of people who still lack access to treatment. HSV is an often-painful chronic viral STI that can cause significant reproductive health challenges and increase an individual’s susceptibility to other infections, including HIV. HPV increases the risk of HIV acquisition and is the principal global cause of cervical and anal cancer. Many people at high risk for acquiring HIV are also at risk for HSV and HPV, and all three infections can be transmitted through either vaginal or anal sex.

In a recent Phase I study of PC-1005, cervicovaginal lavages from women who used the gel vaginally were found to inhibit HIV and HPV in cell-based assays. Women who used PC-1005 had no increase in adverse events over placebo, and 94% of participants expressed a willingness to use the gel in the future. In preclinical studies, PC-1005 performed as well as, or in many cases better than, tenofovir (TFV) 1% gel.

“PC-1005 is part of the Population Council’s ongoing commitment to develop innovative products to improve sexual and reproductive health,” said James Sailer, vice president and executive director of the Population Council’s Center for Biomedical Research. “Population Council scientists are building on decades of experience in the field to develop user-controlled MPTs that will allow men and women to prevent HIV, other STIs, and in some cases unintended pregnancy. Currently, 170 million women worldwide are using contraceptive products developed by the Council or based on our technology.”

MTN-037, led by Craig Hendrix, M.D., director of the rectal microbicide program at MTN and professor of medicine, Johns Hopkins University, is being conducted at the University of Pittsburgh Medical Center and the University of Alabama at Birmingham. The study results, anticipated by mid-2019, will help guide further clinical testing of PC-1005 in larger populations as a potential broad-spectrum, on-demand microbicide for preventing HIV and other STIs.