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.

@article{Justman2018PharmacokineticsAP,
  title={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.},
  author={Jessica E. Justman and Gonasagrie Lulu Nair and Craig W Hendrix and Jeanna M. Piper and Mark A Marzinke and James Y. Dai and Zhenyu Pan and Beth Galaska and Lisa Levy and Jill L. Schwartz and Bhavna Balar and Ratiya Pamela Kunjara Na Ayudhya and Ivy T Mushamiri and Ian McGowan and Charlene S Dezzutti},
  journal={Journal of acquired immune deficiency syndromes},
  year={2018},
  volume={78 2},
  pages={
          175-182
        }
}
BACKGROUND Evidence is lacking regarding whether vaginal pre-exposure prophylaxis with topical tenofovir (TFV) reduces the risk of rectal HIV acquisition. SETTING Bronx, NY. METHODS 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. RESULTS… CONTINUE READING
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