Lopinavir/Ritonavir Administered Intra-Anally for the Prevention of HPV-Related Cancer in Patients Living with HIV with High-Grade Anal Intraepithelial Neoplasia
This phase I trial tests the safety, side effects, and best dose of lopinavir/ritonavir administered intra-anally in preventing human papillomavirus (HPV)-Related cancer in patients living with human immunodeficiency virus (HIV) with high grade anal intraepithelial neoplasia. High-grade anal intraepithelial neoplasia, also known as high-grade anal dysplasia, are precancerous cells that may or may not become a cancer in the future. Most of the changes that lead to cancer are caused by HPV. Unfortunately, there is no known cure for HPV at this time. Usually these precancerous cells are treated with topical treatments or surgery; however, this is not a cure, and these precancerous cells can come back. Protease inhibitor drugs, such as lopinavir and ritonavir, were developed and approved to treat HIV. Laboratory studies demonstrate that these protease inhibitors can also help destroy several proteins that are produced by HPV that result in cancer. Information gained from this trial may allow researchers to determine a safe and effective dose of lopinavir/ritonavir in the form of anal suppositories for treating people living with HIV with high grade anal dysplasia in order to help prevent precancerous cells from becoming cancer in the future.