Because
lubricants may decrease
trauma during coitus, it is hypothesized that they could aid in the prevention of HIV acquisition. Therefore, safety and anti-HIV-1 activity of over-the-counter (OTC) aqueous- (n = 10),
lipid- (n = 2), and
silicone-based (n = 2) products were tested. The rheological properties of the
lipid-based
lubricants precluded testing with the exception of explant safety testing. Six aqueous-based
gels were hyperosmolar, two were nearly iso-osmolar, and two were hypo-osmolar. Evaluation of the panel of products showed Gynol II (a spermicidal gel containing 2%
nonoxynol-9),
KY Jelly, and
Replens were toxic to Lactobacillus. Two nearly iso-osmolar aqueous- and both
silicone-based
gels were not toxic toward epithelial cell lines or ectocervical or colorectal explant tissues. Hyperosmolar
lubricants demonstrated reduction of tissue viability and epithelial fracture/sloughing while the nearly iso-osmolar and
silicon-based
lubricants showed no significant changes in tissue viability or epithelial modifications. While most of the
lubricants had no measurable anti-HIV-1 activity, three
lubricants which retained cell viability did demonstrate modest anti-HIV-1 activity in vitro. To determine if this would result in protection of mucosal tissue or conversely determine if the epithelial damage associated with the hyperosmolar
lubricants increased HIV-1
infection ex vivo, ectocervical tissue was exposed to selected
lubricants and then challenged with HIV-1. None of the
lubricants that had a moderate to high therapeutic index protected the mucosal tissue. These results show hyperosmolar
lubricant gels were associated with cellular toxicity and epithelial damage while showing no anti-viral activity. The two iso-osmolar
lubricants, Good Clean Love and PRÉ, and both
silicone-based
lubricants,
Female Condom 2
lubricant and Wet
Platinum, were the safest in our testing algorithm.