This new Phase I rectal microbicide study, known as MTN-007, aims to determine if rectal use of tenofovir gel is safe, and in particular, does not cause cells in the rectum to become more vulnerable to HIV. Investigators will also ask trial participants questions regarding the gel's desirability. MTN-007 will enroll 60 men and women at the University of Pittsburgh, the University of Alabama at Birmingham, and Fenway Health in Boston. Leading the study is Ian McGowan, M.D., Ph.D., of the University of Pittsburgh, who is also co-principal investigator of the MTN and serves as Scientific Vice-Chair of IRMA.
Little is known about tenofovir gel used rectally, but science is advancing our understanding. Laboratory and animal studies involving rectal application of tenofovir gel have suggested it's safe for testing in humans. In fact, MTN researchers have just completed the first Phase I trial with eighteen participants, called RMP-02/MTN-006, in collaboration with the Microbicide Development Program at the University of California, Los Angeles.
While results of RMP-02/MTN-006 are not expected until early 2011, researchers have already recommended modifications to the gel's formulation. MTN-007 is evaluating the new formulation, which still contains the same amount of active drug 1% percent tenofovir but has a lower concentration of g
|Contact: Jim Pickett|
International Rectal Microbicide Advocates