Julie Russo, Lisa C. Rohan, Bernard Moncla, Ratiya Pamela Na Ayudhya, Lin Wang, Marilyn Cost, Kara Pryke, Marc-André LeBlanc, Jim Pickett, and Charlene S. Dezzutti Magee-Women’s Research Institute, University of Pittsburgh, Pittsburgh, PA; University of Pittsburgh, Pittsburgh, PA; International Rectal Microbicide Advocates, Chicago, IL

Background: Because lubricants may decrease trauma during coitus, it is hypothesized that they could aid in the prevention of HIV acquisition. However, the safety and anti-HIV activity is currently unknown for over-the counter (OTC) lubricant gels. Methods: Based on an International Rectal Microbicide Advocates survey, 6 OTC lubricant gels were tested: 5 aqueous-based (Astroglide, Elbow Grease, ID Glide, KY Jelly, and PRÉ) and 1 condom compatible silicone based (Wet Platinum). Formulation characteristics (pH, osmolarity, and viscosity) were determined. Viability of Lactobacillus species and cells [Caco-2 (colorectal), HEC-1-A (uterine), and TZM-bl (cervical) epithelial cell lines and peripheral blood mononuclear cells (PBMCs)] exposed to the lubricants was evaluated. For cells, dilutions of each aqueous-based lubricant were made; Wet Platinum was used undilute. Transepithelial resistance of Caco-2 and HEC-1-A cell lines was measured to determine the impact of lubricants on epithelial cell monolayers. The anti-HIV activity was tested with the TZM-bl cell line. Colorectal and ectocervical safety was evaluated by the MTT assay and histology after apical application to polarized explant cultures. Results : PRÉ was pH 7, isosmolar, with moderate viscosity. Elbow Grease, ID Glide, and KY Jelly were pH 4 to 5, 9 to 13-fold above isosmolar, with varying degrees of viscosity. Astroglide was pH 4, 21-fold above isosmolar, with low viscosity. KY Jelly which contains chlorhexidine had a complete loss of Lactobacillus viability, but the other lubricants had < log10 loss of bacteria and were considered safe. PRÉ was not toxic up to 1:10 dilution for the PBMCs and cell lines. Elbow Grease, ID Glide, and KY Jelly were not toxic up to 1:100 to 1:200 dilutions. Astroglide was not toxic up to 1:1500 dilution. Wet Platinum had no toxicity. PRÉ had no impact on the epithelial cell monolayers whereas the other aqueous-based lubricants disrupted the epithelial cell monolayers. All lubricants retained colorectal and ectocervical explant viability by MTT assay. Histology showed intact epithelium for PRÉ and Wet Platinum, while epithelial striping was observed for Astroglide, Elbow Grease, ID Glide, and KY Jelly. Lubricants had no measurable anti-HIV activity. Conclusions: Our data suggests that PRÉ and Wet Platinum were safest. The hyperosmolar nature of the other lubricant gels was associated with cellular toxicity and may lead to increased risk of HIV infection.