Content area
Full Text
About the Authors:
Ian Mcgowan
* E-mail: [email protected]
Affiliations University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, United States of America, Microbicide Trials Network, Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America
Craig Hoesley
Affiliation: University of Alabama, Birmingham, Alabama, United States of America
Ross D. Cranston
Affiliation: University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, United States of America
Philip Andrew
Affiliation: FHI 360, Research Triangle Park, Durham, North Carolina, United States of America
Laura Janocko
Affiliation: Microbicide Trials Network, Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America
James Y. Dai
Affiliations University of Washington, Seattle, Washington, United States of America, Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America
Alex Carballo-Dieguez
Affiliation: Columbia University, New York, New York, United States of America
Ratiya Kunjara Na Ayudhya
Affiliation: Microbicide Trials Network, Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America
Jeanna Piper
Affiliation: Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America
Florian Hladik
Affiliations University of Washington, Seattle, Washington, United States of America, Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America
Ken Mayer
Affiliation: Fenway Health, Boston, Massachusetts, United States of America
Introduction
Rectal microbicides (RM) are currently being developed to prevent or at least significantly reduce the risk of HIV acquisition associated with unprotected receptive anal intercourse (RAI) [1]. RAI is a common sexual practice among men who have sex with men (MSM) [2]. Recent epidemiological data have suggested that RAI is also common among men and women in the developed and developing world [3]–[6]. As a consequence there is an urgent need to develop a safe and effective RM. Attention is currently focused on the development of tenofovir (TFV) gel as a potential RM. The vaginal formulation of TFV that was used in the CAPRISA 004 study [7] has been evaluated in a Phase 1 rectal safety study (RMP-02/MTN-006) [8]. Use of the gel was associated with mild to moderate gastrointestinal symptoms including bloating, pain, urgency, and diarrhea. The vaginal formulation of TFV is hyperosmolar (3111 mOsmol/kg) and it is possible that these symptoms were linked to product osmolality...