The human immunodeficiency virus (HIV) pandemic continues to ravage the world with substantial loss of life and reduced quality of life. Approximately 42 million people are infected with HIV worldwide. Currently, approximately 50% of HIV infections are in women and there is a desperate need to develop microbicides to prevent HIV infection. Topical microbicides are vaginally and rectally applied biomedical products with or without contraceptive activity that safely prevent infection of HIV and sexually transmitted infections (STI). This Program will endeavor to produce combination microbicides generated by combining the technology of Starpharma dendrimers and ReProtect's BufferGel TM. The combination of these two active agents with different mechanisms of action will potentially improve efficacy and duration of protection, and broaden the protective spectrum against HIV and other STI pathogens when compared to either parent microbicide while maintaining an adequate safety profile. A multidisciplinary team has been assembled to participate in 3 Projects, 3 Scientific Cores and an Administrative Core. Preclinical developments of combination formulations are planned and will result in pilot Phase 1 clinical evaluation. In addition, this Program will evaluate novel technology for the evaluation of microbicides, optical coherence tomography (OCT). OCT is an imaging technique that detects morphological changes to the cervix and vagina. This non-invasive technique provides results similar to those observed histologically using light microscopy of biopsy specimens. Previously the assessment of the effects of microbicides on the integrity of the cervicovaginal epithelium has relied on colposcopic examination and biopsy. Unfortunately colposcopy is relatively insensitive and biopsies are invasive. The integrated approach in this Program will rapidly advance the field of microbicides by developing combination microbicides and by introducing novel, non-invasive analysis for the evaluation of microbicide safety.
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