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FAME-04: A Phase 1 trial to assess the safety, acceptability, pharmacokinetics and pharmacodynamics of film and gel formulations of tenofovir.
Bunge KE, Dezzutti CS, Hendrix CW, Marzinke MA, Spiegel HML, Moncla BJ, Schwartz JL, Meyn LA, Richardson-Harman N, Rohan LC, Hillier SL. Bunge KE, et al. Among authors: spiegel hml. J Int AIDS Soc. 2018 Aug;21(8):e25156. doi: 10.1002/jia2.25156. J Int AIDS Soc. 2018. PMID: 30101439 Free PMC article. Clinical Trial.
Pharmacokinetics and pharmacodynamics in HIV prevention; current status and future directions: a summary of the DAIDS and BMGF sponsored think tank on pharmacokinetics (PK)/pharmacodynamics (PD) in HIV prevention.
Romano J, Kashuba A, Becker S, Cummins J, Turpin J, Veronese F; Antiretroviral Pharmacology In HIV Prevention Think Tank Participants. Romano J, et al. AIDS Res Hum Retroviruses. 2013 Nov;29(11):1418-27. doi: 10.1089/aid.2013.0122. Epub 2013 May 22. AIDS Res Hum Retroviruses. 2013. PMID: 23614610 Free PMC article. Review.
A Phase 1 Randomized, Open Label, Rectal Safety, Acceptability, Pharmacokinetic, and Pharmacodynamic Study of Three Formulations of Tenofovir 1% Gel (the CHARM-01 Study).
Mcgowan I, Cranston RD, Duffill K, Siegel A, Engstrom JC, Nikiforov A, Jacobson C, Rehman KK, Elliott J, Khanukhova E, Abebe K, Mauck C, Spiegel HM, Dezzutti CS, Rohan LC, Marzinke MA, Hiruy H, Hendrix CW, Richardson-Harman N, Anton PA. Mcgowan I, et al. PLoS One. 2015 May 5;10(5):e0125363. doi: 10.1371/journal.pone.0125363. eCollection 2015. PLoS One. 2015. PMID: 25942472 Free PMC article. Clinical Trial.
A Phase 1 Randomized, Blinded Comparison of the Pharmacokinetics and Colonic Distribution of Three Candidate Rectal Microbicide Formulations of Tenofovir 1% Gel with Simulated Unprotected Sex (CHARM-02).
Hiruy H, Fuchs EJ, Marzinke MA, Bakshi RP, Breakey JC, Aung WS, Manohar M, Yue C, Caffo BS, Du Y, Abebe KZ, Spiegel HM, Rohan LC, McGowan I, Hendrix CW. Hiruy H, et al. AIDS Res Hum Retroviruses. 2015 Nov;31(11):1098-108. doi: 10.1089/AID.2015.0098. Epub 2015 Aug 24. AIDS Res Hum Retroviruses. 2015. PMID: 26227279 Free PMC article. Clinical Trial.
Tenofovir disoproxil fumarate intravaginal ring for HIV pre-exposure prophylaxis in sexually active women: a phase 1, single-blind, randomised, controlled trial.
Keller MJ, Wood L, Billingsley JM, Ray LL, Goymer J, Sinclair S, McGinn AP, Marzinke MA, Frank B, Srinivasan S, Liu C, Atrio JM, Espinoza L, Mugo N, Spiegel HML, Anderson PL, Fredricks DN, Hendrix CW, Marrazzo J, Bosinger SE, Herold BC. Keller MJ, et al. Among authors: spiegel hml. Lancet HIV. 2019 Aug;6(8):e498-e508. doi: 10.1016/S2352-3018(19)30145-6. Epub 2019 Jul 15. Lancet HIV. 2019. PMID: 31320290 Free PMC article. Clinical Trial.
40 results