Globally, the majority of new HIV-1 infections occur via sexual transmission.
In many parts of the world, including sub-Saharan Africa, there is limited or no access to OTC lubricant products. Because microtrauma that can occur during sex  ,  ,  could create portals of entry, there is an assumption that lubricant use could help reduce the risk of sexual transmission of HIV-1 . The risk of HIV-1 acquisition during coitus is greatest for those persons engaging in receptive anal intercourse without using a condom  , .
Skin lotions are for external use only. He made a few literary friends, notably Evelyn Waugh and the Sitwells, but he later said the real value of the job was that reading so many bad submissions every week taught him how not to write. Both vehicles will be on display until approximately noon. Additionally, base oil oxidation can alter the lubricant viscosity and lead to the formation of sludge and varnish. All things considered, it turned out well. And fate caused her new life to start right then and there. She learned lots of things that made her feel more capable.
A recent study showed that men who have sex with men MSM and engage in anal intercourse frequently use OTC lubricant products without condoms . However, little information has been documented regarding safety of OTC lubricants. Generally, limited safety testing has been done on these products.
Because OTC lubricant products are utilized in microbicide trials and are used most frequently by persons engaging in coitus with the highest risk of HIV-1 acquisition, it is important to know their impact on the tissues where they will be applied, which are the gastrointestinal and female genital tracts.
Several products representing aqueous-, lipid-, and silicone-based gels were evaluated for their safety and anti-HIV-1 activity using our pre-clinical testing algorithm which is the same one used to evaluate formulated microbicides . OTC lubricant products were purchased from www.
For each of the lubricant products, the formulation without additional flavors, scents, or other enhancements e. Normal human ectocervical and colorectal tissues were acquired from pre-menopausal women undergoing hysterectomy or persons undergoing colorectal surgery for non-inflammatory conditions, respectively. All tissue was obtained through IRB approved protocols and at the University of Pittsburgh collected through an Honest Broker de-linking patient identifiers to the investigators.
Unless otherwise stated, culture reagents were purchased from Hyclone Logan, UT. The major physicochemical parameters typically evaluated for aqueous semi-solids include viscosity, osmolality, and pH. Viscosity was measured using a program where speed was increased from 0. One strain of L. Minimum cidal concentrations, the concentration required to reduce the viability of a culture by OTC lubricant products were mixed with an equal volume of the bacterial suspensions at room temperature and plated for colony forming units CFUs. The number of CFUs was taken from the dilution plate containing 50 to colonies.
All reported values represent the average of triplicate experiments. Samples were taken at time 0 and after 30 min of exposure. Samples yielding 10 or fewer CFUs representing a All results were compared to the control which was identical but lacking the OTC lubricant products. FC2 lubricant and Wet Platinum were used neat.
Dilutions of gels made in the appropriate medium were added to the appropriate wells. Control wells with no treatment cells only were included for background luminescence. To determine the effect of the aqueous gels on epithelial integrity, the TER was measured as described previously . As controls, wells with no cells background resistance and wells with cells alone were used.
After the experiment was complete, the plate was read on the DTX plate reader. Polarized ectocervical and colorectal explant cultures were set-up as previously described  , . The explants were prepared on day of surgery in duplicate. FC 2 lubricant and Wet Platinum were applied undiluted. The next day, explants were washed and viability was evaluated using the MTT [1- 4,5-dimethylthiazolyl -3,5-diphenylformazan] assay and histology  , .
The toxicity was determined as described above.
Controls included medium alone background luminescence and HIV-1 only maximum luminescence. All treatments were tested in triplicate. Explants with medium only were used as infection controls. After 18 h, the explants were washed with HBSS to remove residual gel. On two additional explants, 0. Fresh medium was applied to the basolateral compartment. To assess differences in percent viability and percent transmission between experimental and control groups, an ANOVA model was fit with log-transformed outcomes controlling for repeated measures.
Exponentiated coefficients from the regression model were then used as consistent estimators of percent viability and percent transmission and were tested to assess difference from 0 with F-tests with Bonferroni adjustments for multiple comparisons within the assay. To assess the difference between the gel and control TER, an ANOVA model was fit with the difference between the gel and control TER measures as the outcome adjusting for measurement time and replication and the -1 day measurement. The difference at each time point was estimated and tested using an F-test to determine whether it differs from the baseline pre-exposure difference between the groups with Bonferroni adjustments for multiple comparisons.
Linear mixed effects models with random intercepts were used to assess the difference in p24 between lubricant-treated and control tissues over time. T-tests with Bonferroni adjustments for multiple comparisons were used to test for differences over time. To better understand how the OTC lubricant products may perform in our experiments, basic formulation characterizations such as pH, osmolality, and viscosity testing were done Table 1 . The pH and osmolality were determined for the 10 aqueous-based gels tested.
Seven of them were acidic. The other three had a neutral pH. Boy Butter H 2 O, a lipid-based gel that is water soluble, had a neutral pH. Sliquid Organic was 2. The remaining aqueous-based products and Boy Butter H 2 O had osmolalities ranging from 4.
To note, Astroglide was The viscosities ranged from cps very thin for Wet Platinum to cps very thick for Gynol II at room temperature. Lactobacillus species are important for the maintenance of the female genital tract as they produce lactic acid and hydrogen peroxide.
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Loss of lactobacilli often coincides with an increased susceptibility to HIV-1 infection . Therefore, three species of lactobacilli were tested for retention of viability in the presence of the lubricants Figure 1. A 1 log 10 reduction in bacterial growth was considered a significant loss. Astroglide reduced the growth of one of the L. Replens and Gynol II showed complete loss of both L. The L. However, it is not clear why the L. Exposure to KY Jelly resulted in complete loss of the three strains of lactobacilli, likely attributed to chlorhexidine in the formulation which is a known bactericidal compound.
The remaining aqueous-, lipid-, and silicone-based products had no detrimental effect on bacterial viability. Lactobacillus species L. The reduction of colony forming units was compared to control cultures. The data are presented as the Log 10 growth compared to the control cultures.
Because the products will interact directly with epithelial cells, dilutions of aqueous-based products were made in the appropriate medium for safety testing on Caco-2 and HECA epithelial cell lines Figure 2.
In general, the loss of cell viability correlated to the osmolality of the gels; the higher the solute concentration, the greater the dilution that was needed to maintain viability. Interestingly, Slippery Stuff was the most hypo-osmolar gel tested, but retained cell viability.
Because FC 2 lubricant and Wet Platinum are silicone-based gels and not water soluble, they cannot be diluted appropriately in culture medium. To address this issue, the silicone-based products were applied directly to the cells for 15, 30, or 60 min before medium was applied.