The Population Council, in collaboration with the University of Alabama at Birmingham (UAB), announced today the launch of a Phase 1 trial of PC-1005 vaginal gel, a novel multipurpose prevention technology (MPT). Thirty healthy, HIV-negative women will be enrolled in the trial to evaluate the safety, acceptability, and pharmacokinetic profile of PC-1005 gel.
The antiretroviral-based microbicide gel contains MIV-150, an enzyme inhibitor that prevents HIV-infected cells from producing new virus; zinc acetate, an antiviral agent with activity against HIV and herpes simplex virus (HSV); and carrageenan, a natural product derived from seaweed that has been shown to have potent activity against human papillomavirus (HPV).
In preclinical studies, PC-1005 has shown considerable promise in preventing infection with HIV, herpes simplex virus-type 2 (HSV-2), and HPV. The gel completely blocked vaginal infection with SHIV-RT (a virus combining genes from HIV and SIV, the monkey version of HIV) in macaques when applied up to 8 hours before exposure to the virus. It also reduced rectal infection with SHIV-RT when applied 1 hour before exposure. In mice, the gel prevented vaginal and rectal infection with HSV-2 and HPV.
Data from a recently completed open-label safety study conducted at UAB—the first-in-human trial of PC-1005—indicated that the gel was well tolerated by the five women who applied it once daily for three days. Council researchers and collaborators at UAB are beginning a double-blind, randomized Phase 1 trial with 30 sexually abstinent women aged 19–49 who will apply PC-1005 or a placebo gel once daily for 14 days. Safety will be assessed via physical exams and laboratory testing with blood draws to determine the pharmacokinetic profile of MIV-150 and zinc acetate. Acceptability of the gel will be evaluated via self-administered questionnaires and in-depth interviews.
“If proven effective, multipurpose prevention technologies like PC-1005 that protect against HIV and other STIs could contribute substantially to the health of women and girls around the globe,” said Barbara Friedland, Population Council associate and manager of the clinical trial.
The Council is also developing two sustained-release vaginal rings that employ the same antiviral agents (MIV-150, zinc acetate, and carrageenan) as PC-1005. One ring is designed to prevent the sexual transmission of HIV and other STIs, and the other—with the addition of the licensed contraceptive levornorgestrel—to prevent HIV, other STIs, and unintended pregnancy. Compared with single-indication products, an MPT that protects against multiple STIs has the potential to be more convenient for the user and cheaper and easier for health systems to provide. For these reasons, the MPT may be more likely to be used.
This research is made possible by the generous support of the American people through the US Agency for International Development (USAID), GPO-A-00-04-00019-00. The contents are the responsibility of the authors and do not necessarily reflect the views of USAID or the United States Government.
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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Erin Kiernon: firstname.lastname@example.org; +1 212 339 0653