title: Rectal application of a highly osmolar personal lubricant in a macaque model induces acute cytotoxicity but does not increase risk of SHIV infection.
abstract: BACKGROUND
  Personal lubricant use is common during anal intercourse. Some water-based products with high osmolality and low pH can damage genital and rectal tissues, and the polymer polyquaternium 15 (PQ15) can enhance HIV replication in vitro. This has raised concerns that lubricants with such properties may increase STD/HIV infection risk, although in vivo evidence is scarce. We use a macaque model to evaluate rectal cytotoxicity and SHIV infection risk after use of a highly osmolar (>8,000 mOsm/kg) water-based lubricant with pH of 4.4, and containing PQ15.
  
  
  METHODS
  Cytotoxicity was documented by measuring inflammatory cytokines and epithelial tissue sloughing during six weeks of repeated, non-traumatic lubricant or control buffer applications to rectum and anus. We measured susceptibility to SHIVSF162P3 infection by comparing virus doses needed for rectal infection in twenty-one macaques treated with lubricant or control buffer 30 minutes prior to virus exposure.
  
  
  RESULTS
  Lubricant increased pro-inflammatory cytokines and tissue sloughing while control buffer (phosphate buffered saline; PBS) did not. However, the estimated AID50 (50% animal infectious dose) was not different in lubricant- and control buffer-treated macaques (p = 0.4467; logistic regression models).
  
  
  CONCLUSIONS
  Although the test lubricant caused acute cytotoxicity in rectal tissues, it did not increase susceptibility to infection in this macaque model. Thus neither the lubricant-induced type/extent of inflammation nor the presence of PQ15 affected infection risk. This study constitutes a first step in the in vivo evaluation of lubricants with regards to HIV transmission.
authors: National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Atlanta, Georgia, United States of America.
authors: Sundaram A
authors: SA
authors: Vishwanathan
authors: National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Atlanta, Georgia, United States of America.
authors: Monica R
authors: MR
authors: Morris
authors: National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Atlanta, Georgia, United States of America.
authors: Richard J
authors: RJ
authors: Wolitski
authors: National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Atlanta, Georgia, United States of America.
authors: Wei
authors: W
authors: Luo
authors: National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Atlanta, Georgia, United States of America.
authors: Charles E
authors: CE
authors: Rose
authors: National Center for Emerging & Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.
authors: Dianna M
authors: DM
authors: Blau
authors: National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Atlanta, Georgia, United States of America.
authors: Theodros
authors: T
authors: Tsegaye
authors: National Center for Emerging & Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.
authors: Sherif R
authors: SR
authors: Zaki
authors: National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Atlanta, Georgia, United States of America.
authors: David A
authors: DA
authors: Garber
authors: National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Atlanta, Georgia, United States of America.
authors: Leecresia T
authors: LT
authors: Jenkins
authors: National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Atlanta, Georgia, United States of America.
authors: Tara C
authors: TC
authors: Henning
authors: University of Washington, Seattle, Washington, United States of America.
authors: Dorothy L
authors: DL
authors: Patton
authors: National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Atlanta, Georgia, United States of America.
authors: R Michael
authors: RM
authors: Hendry
authors: National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Atlanta, Georgia, United States of America.
authors: Janet M
authors: JM
authors: McNicholl
authors: National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Atlanta, Georgia, United States of America.
authors: Ellen N
authors: EN
authors: Kersh
mesh_terms: D000818:Animals; D004848:Epithelium / Q000187:drug effects; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006863:Hydrogen-Ion Concentration; D054327:Lubricants / Q000008:administration & dosage / Q000737:chemistry* / Q000633:toxicity*; D008252:Macaca fascicularis; D064307:Microbiota / Q000187:drug effects; D009994:Osmolar Concentration; D012007:Rectum / Q000166:cytology / Q000187:drug effects* / Q000382:microbiology / Q000821:virology*; D012306:Risk; D016097:Simian Acquired Immunodeficiency Syndrome / Q000635:transmission; D015302:Simian Immunodeficiency Virus / Q000187:drug effects* / Q000502:physiology; D013997:Time Factors; D014766:Viremia / Q000139:chemically induced; D017201:Virus Shedding / Q000187:drug effects; D014867:Water / Q000737:chemistry
chemical_list: D054327:Lubricants; D014867:Water