Clinical Trials

In 2004, the National Institutes of Health (NIH) awarded CPR a grant to accelerate product development for microbicides. Over a five-year period, CPR is now coordinating an international effort with colleagues in industry, academia and government, advancing new drugs through laboratory and animal testing into early human trials.

The candidate microbicides currently being studied for rectal use in our program as well are vaginal formulations of topical anti-retroviral drugs: PMPA, UC-781, and TMC-120. These formulations are intended to prevent replication of the pathogen once it enters the body. Each product undergoes rigorous testing in lab, animal and human clinical trials. We have recently begun a Phase I human safety trial of the rectal use of the vaginal formulation of UC-781. Results of this study can be expected in early 2009.

CPR has also been awarded a five-year NIH U01 grant to examine a new microbicide using aptamers created by collaborators at Oxford, England. Aptamers are small strands of RNA that can block the ability of viruses to attach to cells. This study will be done in the lab against HIV, HSV-2 (herpes) and HPV-16 (genital warts).

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Volunteers are essential for the success of our clinical research program.