Pharmacokinetics and Pharmacodynamics of Tenofovir Reduced-Glycerin 1% Gel in the Rectal and Vaginal Compartments in Women: A Cross-Compartmental Study With Directly Observed Dosing

Journal of Acquired Immune Deficiency Syndromes : JAIDS
Jessica E JustmanMTN-014 Study Team

Abstract

Evidence is lacking regarding whether vaginal pre-exposure prophylaxis with topical tenofovir (TFV) reduces the risk of rectal HIV acquisition. Bronx, NY. MTN-014 was a phase 1, cross-over, randomized sequence trial comparing the cross-compartment pharmacokinetics and pharmacodynamics of daily TFV reduced-glycerin 1% gel after 14 days each of rectal and vaginal application, with directly observed dosing and a 6-week washout period between phases. Fourteen HIV-uninfected women enrolled; 91% of doses were observed and 13 women completed all study procedures. TFV and TFV diphosphate (TFV-DP) were detected in most samples collected from the dosing compartment. After vaginal dosing, TFV was detected in 10/14 samples of rectal fluid (RF) (median 4.4 ng/sponge) and 1/13 rectal tissue samples (0.2 ng/mg); TFV-DP was detected in 2/13 rectal tissue samples at 59.8 and 76.5 fmol/mg. After rectal dosing, TFV was detected in 9/14 samples of vaginal fluid (median 1.1 ng/swab) and in 6/14 vaginal tissue samples (median below limit of quantification); TFV-DP was detected in 3/14 vaginal tissue samples at 17.3, 87.6, and 77.1 fmol/mg. Neither cervicovaginal lavage fluid nor RF collected 24 hours after rectal or vaginal dosing resulted in a stat...Continue Reading

References

Aug 19, 2000·Archives of Sexual Behavior·J I Baldwin, J D Baldwin
Jul 11, 2006·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Tracy KingCourtney V Fletcher
Nov 26, 2010·The New England Journal of Medicine·Robert M GrantUNKNOWN iPrEx Study Team
Sep 23, 2011·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Nicolette A LouissaintCraig W Hendrix
Oct 12, 2011·Antimicrobial Agents and Chemotherapy·Jeremy NuttallJoseph Romano
May 15, 2012·The Journal of Antimicrobial Chemotherapy·Charlene S DezzuttiDavid Friend
Jul 13, 2012·The New England Journal of Medicine·Jared M BaetenUNKNOWN Partners PrEP Study Team
Jul 13, 2012·The New England Journal of Medicine·Michael C ThigpenUNKNOWN TDF2 Study Group
Jan 3, 2013·American Journal of Reproductive Immunology : AJRI·Rebecca F BaggaleyMarie-Claude Boily
Sep 18, 2013·Proceedings of the National Academy of Sciences of the United States of America·James M SmithPatrick F Kiser
Feb 5, 2015·The New England Journal of Medicine·Jeanne M MarrazzoUNKNOWN VOICE Study Team
Jul 1, 2015·The Journal of Infectious Diseases·James Y DaiElizabeth R Brown
Aug 21, 2015·The Journal of Sexual Medicine·Lyndsey S BensonAmy K Whitaker
Feb 12, 2017·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Lenine J P LiebenbergJo-Ann S Passmore
Jun 3, 2017·Science·Nichole R KlattAdam D Burgener

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Citations

Sep 11, 2018·Clinical Pharmacology and Therapeutics·Craig W Hendrix
Oct 29, 2019·Current Opinion in HIV and AIDS·Thesla Palanee-Phillips, Jared M Baeten
Oct 16, 2019·Annual Review of Medicine·Jared M BaetenSharon L Hillier
Dec 7, 2019·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Kathryn PeeblesUNKNOWN MTN-020/ASPIRE Study Team
Mar 23, 2021·AIDS Research and Human Retroviruses·Ian Michael McGowanOliver Hartley

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