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A Phase 1 Trial to Assess the Safety, Acceptability, Pharmacokinetics, and Pharmacodynamics of a Novel Dapivirine Vaginal Film.
Bunge KE, Dezzutti CS, Rohan LC, Hendrix CW, Marzinke MA, Richardson-Harman N, Moncla BJ, Devlin B, Meyn LA, Spiegel HM, Hillier SL. Bunge KE, et al. Among authors: spiegel hm. J Acquir Immune Defic Syndr. 2016 Apr 15;71(5):498-505. doi: 10.1097/QAI.0000000000000897. J Acquir Immune Defic Syndr. 2016. PMID: 26565716 Free PMC article. Clinical Trial.
Decline in CD4 T lymphocytes with monotherapy bridging strategy for non-adherent adolescents living with HIV infection: Results of the IMPAACT P1094 randomized trial.
Agwu AL, Warshaw MG, McFarland EJ, Siberry GK, Melvin AJ, Wiznia AA, Fairlie L, Boyd S, Harding P, Spiegel HML, Abrams EJ, Carey VJ; P1094 Study Team. Agwu AL, et al. PLoS One. 2017 Jun 12;12(6):e0178075. doi: 10.1371/journal.pone.0178075. eCollection 2017. PLoS One. 2017. PMID: 28604824 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.
Tenofovir Diphosphate Concentrations in Dried Blood Spots From Pregnant and Postpartum Adolescent and Young Women Receiving Daily Observed Pre-exposure Prophylaxis in Sub-Saharan Africa.
Stranix-Chibanda L, Anderson PL, Kacanek D, Hosek S, Huang S, Nematadzira TG, Taulo F, Korutaro V, Nakabiito C, Masenya M, Lypen K, Brown E, Ibrahim ME, Yager J, Wiesner L, Johnston B, Amico KR, Rooney JF, Chakhtoura N, Spiegel HML, Chi BH; IMPAACT 2009 Team. Stranix-Chibanda L, et al. Among authors: spiegel hml. Clin Infect Dis. 2021 Oct 5;73(7):e1893-e1900. doi: 10.1093/cid/ciaa1872. Clin Infect Dis. 2021. PMID: 33341883 Free PMC article. Clinical Trial.
Critical need for appropriate mucosal sample collection to determine relational animal pharmacokinetic-pharmacodynamic models in HIV prevention.
Marshall L, Cummins J, Spiegel H, Turpin J, Veronese F, Kashuba A; HIV Prevention Pharmacology Best Practices Working Group. Marshall L, et al. AIDS Res Hum Retroviruses. 2013 Nov;29(11):1398-400. doi: 10.1089/AID.2013.0142. Epub 2013 Aug 30. AIDS Res Hum Retroviruses. 2013. PMID: 23909474 Free PMC article. No abstract available.
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.
49 results