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A Multiple Dose Phase 1 Assessment of Rilpivirine Long Acting in a Model of Preexposure Prophylaxis Against HIV.

Cranston RD, Dezzutti CS, Siegel A, Engstrom J, Shetler C, Richardson-Harman N, Abebe KZ, Back D, Else L, Egan D, Khoo S, Egan JE, Stall R, Williams P, Brand RM, Parikh UM, McGowan I.

AIDS Res Hum Retroviruses. 2019 Sep;35(9):794-804. doi: 10.1089/AID.2018.0265. Epub 2019 Jul 16.


A Mixed-Methods Study Examining Adherence to and Acceptability of Intravaginal Rings for HIV Prevention: Behavioral Results of MTN-027.

Bauermeister JA, Golinkoff JM, Carballo-Diéguez A, Giguere R, López D, Hoesley CJ, Chen BA, Anderson P, Dezzutti CS, Strizki J, Sprinkle C, Heard F, Hall W, Jacobson C, Berthiaume J, Mayo A, Richardson BA, Piper J; Microbicide Trials Network 027 Study Team.

AIDS Behav. 2019 Mar 15. doi: 10.1007/s10461-019-02457-0. [Epub ahead of print]


Pharmacokinetics of Dapivirine Transfer into Blood Plasma, Breast Milk, and Cervicovaginal Fluid of Lactating Women Using the Dapivirine Vaginal Ring.

Noguchi LM, Hoesley C, Kelly C, Scheckter R, Bunge K, Nel A, Marzinke MA, Hendrix CW, Dezzutti CS, Hillier SL, Bogen DL, Piper JM, Beigi RH.

Antimicrob Agents Chemother. 2019 Feb 26;63(3). pii: e01930-18. doi: 10.1128/AAC.01930-18. Print 2019 Mar.


Phase 2a Safety, Pharmacokinetics, and Acceptability of Dapivirine Vaginal Rings in US Postmenopausal Women.

Chen BA, Zhang J, Gundacker HM, Hendrix CW, Hoesley CJ, Salata RA, Dezzutti CS, van der Straten A, Hall WB, Jacobson CE, Johnson S, McGowan I, Nel AM, Soto-Torres L, Marzinke MA; MTN-024/IPM 031 Protocol Team for the Microbicide Trials Network .

Clin Infect Dis. 2019 Mar 19;68(7):1144-1151. doi: 10.1093/cid/ciy654.


Phase 1 Pharmacokinetic Trial of 2 Intravaginal Rings Containing Different Dose Strengths of Vicriviroc (MK-4176) and MK-2048.

Liu AY, Zhang J, Anderson PL, Wagner T, Pan Z, Peda M, Gomez K, Beamer M, Jacobson C, Strizki J, Dezzutti CS, Piper JM; MTN-028 Protocol Team for the Microbicide Trials Network.

Clin Infect Dis. 2019 Mar 19;68(7):1129-1135. doi: 10.1093/cid/ciy652.


Phase 1 Safety and Pharmacokinetics Study of MK-2048/Vicriviroc (MK-4176)/MK-2048A Intravaginal Rings.

Hoesley CJ, Chen BA, Anderson PL, Dezzutti CS, Strizki J, Sprinkle C, Heard F, Bauermeister J, Hall W, Jacobson C, Berthiaume J, Mayo A, Gundacker H, Richardson-Harman N, Piper J; Microbicide Trials Network 027 Study Team.

Clin Infect Dis. 2019 Mar 19;68(7):1136-1143. doi: 10.1093/cid/ciy653.


Vaginal Product Formulation Alters the Innate Antiviral Activity and Glycome of Cervicovaginal Fluids with Implications for Viral Susceptibility.

Koppolu S, Wang L, Mathur A, Nigam JA, Dezzutti CS, Isaacs C, Meyn L, Bunge KE, Moncla BJ, Hillier SL, Rohan LC, Mahal LK.

ACS Infect Dis. 2018 Nov 9;4(11):1613-1622. doi: 10.1021/acsinfecdis.8b00157. Epub 2018 Sep 19.


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.

J Int AIDS Soc. 2018 Aug;21(8):e25156. doi: 10.1002/jia2.25156.


Cryopreservation of human mucosal tissues.

Hughes SM, Ferre AL, Yandura SE, Shetler C, Baker CAR, Calienes F, Levy CN, Astronomo RD, Shu Z, Lentz GM, Fialkow M, Kirby AC, McElrath MJ, Sinclair E, Rohan LC, Anderson PL, Shacklett BL, Dezzutti CS, Gao D, Hladik F.

PLoS One. 2018 Jul 30;13(7):e0200653. doi: 10.1371/journal.pone.0200653. eCollection 2018.


Randomized, placebo controlled phase I trial of safety, pharmacokinetics, pharmacodynamics and acceptability of tenofovir and tenofovir plus levonorgestrel vaginal rings in women.

Thurman AR, Schwartz JL, Brache V, Clark MR, McCormick T, Chandra N, Marzinke MA, Stanczyk FZ, Dezzutti CS, Hillier SL, Herold BC, Fichorova R, Asin SN, Rollenhagen C, Weiner D, Kiser P, Doncel GF.

PLoS One. 2018 Jun 28;13(6):e0199778. doi: 10.1371/journal.pone.0199778. eCollection 2018.


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.

Justman JE, Nair GL, Hendrix CW, Piper JM, Marzinke MA, Dai JY, Pan Z, Galaska B, Levy L, Schwartz JL, Balar B, Kunjara Na Ayudhya RP, Mushamiri I, McGowan I, Dezzutti CS; MTN-014 Study Team.

J Acquir Immune Defic Syndr. 2018 Jun 1;78(2):175-182. doi: 10.1097/QAI.0000000000001655.


Heterogeneity of HIV-1 Replication in Ectocervical and Vaginal Tissue Ex Vivo.

Dezzutti CS, Park SY, Marks KM, Lawlor SE, Russo JR, Macio I, Chappell CA, Bunge KE.

AIDS Res Hum Retroviruses. 2018 Feb;34(2):185-192. doi: 10.1089/AID.2017.0107. Epub 2017 Dec 14.


Analytical Advances in the Ex Vivo Challenge Efficacy Assay.

Richardson-Harman N, Parody R, Anton P, McGowan I, Doncel G, Thurman AR, Herrera C, Kordy K, Fox J, Tanner K, Swartz G, Dezzutti CS.

AIDS Res Hum Retroviruses. 2017 Apr;33(4):395-403. doi: 10.1089/AID.2016.0073. Epub 2016 Dec 16.


Long-acting rilpivirine as potential pre-exposure prophylaxis for HIV-1 prevention (the MWRI-01 study): an open-label, phase 1, compartmental, pharmacokinetic and pharmacodynamic assessment.

McGowan I, Dezzutti CS, Siegel A, Engstrom J, Nikiforov A, Duffill K, Shetler C, Richardson-Harman N, Abebe K, Back D, Else L, Egan D, Khoo S, Egan JE, Stall R, Williams PE, Rehman KK, Adler A, Brand RM, Chen B, Achilles S, Cranston RD.

Lancet HIV. 2016 Dec;3(12):e569-e578. doi: 10.1016/S2352-3018(16)30113-8. Epub 2016 Sep 16.


The Effect of Commonly Used Excipients on the Epithelial Integrity of Human Cervicovaginal Tissue.

Hu M, Zhou T, Dezzutti CS, Rohan LC.

AIDS Res Hum Retroviruses. 2016 Oct/Nov;32(10-11):992-1004. Erratum in: AIDS Res Hum Retroviruses. 2017 Nov;33(11):1180.


Non-Antiretroviral Microbicides for HIV Prevention.

Scott Y, Dezzutti CS.

AIDS Rev. 2016 Jul-Sep;18(3):145-150.


Pharmacodynamic correlations using fresh and cryopreserved tissue following use of vaginal rings containing dapivirine and/or maraviroc in a randomized, placebo controlled trial.

Dezzutti CS, Richardson-Harman N, Rohan LC, Marzinke MA, Hoesley CJ, Panther L, Johnson S, Nuttall JP, Nel A, Chen BA; Microbicide Trials Network, MTN-013IPM 026 Protocol Team.

Medicine (Baltimore). 2016 Jul;95(28):e4174. doi: 10.1097/MD.0000000000004174.


Detectable Tenofovir Levels in Breast-Feeding Infants of Mothers Exposed to Topical Tenofovir.

Noguchi LM, Montgomery ET, Biggio JR, Hendrix CW, Bogen DL, Hillier SL, Dai JY, Piper JM, Marzinke MA, Dezzutti CS, Isaacs SK, Schwartz JL, Watts DH, Beigi RH.

Antimicrob Agents Chemother. 2016 Aug 22;60(9):5616-9. doi: 10.1128/AAC.00645-16. Print 2016 Sep.


Cryopreservation of Human Mucosal Leukocytes.

Hughes SM, Shu Z, Levy CN, Ferre AL, Hartig H, Fang C, Lentz G, Fialkow M, Kirby AC, Adams Waldorf KM, Veazey RS, Germann A, von Briesen H, McElrath MJ, Dezzutti CS, Sinclair E, Baker CA, Shacklett BL, Gao D, Hladik F.

PLoS One. 2016 May 27;11(5):e0156293. doi: 10.1371/journal.pone.0156293. eCollection 2016.


Distinct Pharmacodynamic Activity of Rilpivirine in Ectocervical and Colonic Explant Tissue.

Dezzutti CS, Else LJ, Yandura SE, Shetler C, Russo J, Back DJ, McGowan I.

Antimicrob Agents Chemother. 2016 Apr 22;60(5):2765-70. doi: 10.1128/AAC.00167-16. Print 2016 May.


Broadly Neutralizing Anti-HIV Antibodies Prevent HIV Infection of Mucosal Tissue Ex Vivo.

Scott YM, Park SY, Dezzutti CS.

Antimicrob Agents Chemother. 2015 Nov 23;60(2):904-12. doi: 10.1128/AAC.02097-15. Print 2016 Feb.


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.

J Acquir Immune Defic Syndr. 2016 Apr 15;71(5):498-505. doi: 10.1097/QAI.0000000000000897.


Animal and human mucosal tissue models to study HIV biomedical interventions: can we predict success?

Dezzutti CS.

J Int AIDS Soc. 2015 Nov 2;18:20301. doi: 10.7448/IAS.18.1.20301. eCollection 2015. Review.


Impact of Sex on the Pharmacokinetics and Pharmacodynamics of 1% Tenofovir Gel.

Herold BC, Chen BA, Salata RA, Marzinke MA, Kelly CW, Dezzutti CS, McGowan I, Galaska B, Levy L, Piper JM, Hillier S, Hendrix CW.

Clin Infect Dis. 2016 Feb 1;62(3):375-382. doi: 10.1093/cid/civ913. Epub 2015 Oct 27.


Soluble Immune Mediators and Vaginal Bacteria Impact Innate Genital Mucosal Antimicrobial Activity in Young Women.

Pellett Madan R, Dezzutti CS, Rabe L, Hillier SL, Marrazzo J, McGowan I, Richardson BA, Herold BC; Microbicide Trials Network Biomedical Sciences working Group and the MTN 004 Protocol Team.

Am J Reprod Immunol. 2015 Oct;74(4):323-32. doi: 10.1111/aji.12412. Epub 2015 Jun 26.


Levels of Genital Tract Defensins and Cytokines Differ between HIV-Uninfected US and African Women.

Murphy K, Richardson BA, Dezzutti CS, Marrazzo J, Hillier SL, Hendrix CW, Herold BC.

Am J Reprod Immunol. 2015 Oct;74(4):313-22. doi: 10.1111/aji.12411. Epub 2015 Jun 21.


The rational design and development of a dual chamber vaginal/rectal microbicide gel formulation for HIV prevention.

Ham AS, Nugent ST, Peters JJ, Katz DF, Shelter CM, Dezzutti CS, Boczar AD, Buckheit KW, Buckheit RW Jr.

Antiviral Res. 2015 Aug;120:153-64. doi: 10.1016/j.antiviral.2015.06.010. Epub 2015 Jun 17.


Pharmacodynamic Activity of Dapivirine and Maraviroc Single Entity and Combination Topical Gels for HIV-1 Prevention.

Dezzutti CS, Yandura S, Wang L, Moncla B, Teeple EA, Devlin B, Nuttall J, Brown ER, Rohan LC.

Pharm Res. 2015 Nov;32(11):3768-81. doi: 10.1007/s11095-015-1738-7. Epub 2015 Jun 16.


Phase 1 Safety, Pharmacokinetics, and Pharmacodynamics of Dapivirine and Maraviroc Vaginal Rings: A Double-Blind Randomized Trial.

Chen BA, Panther L, Marzinke MA, Hendrix CW, Hoesley CJ, van der Straten A, Husnik MJ, Soto-Torres L, Nel A, Johnson S, Richardson-Harman N, Rabe LK, Dezzutti CS.

J Acquir Immune Defic Syndr. 2015 Nov 1;70(3):242-9. doi: 10.1097/QAI.0000000000000702.


Assessing the potential of the Woman's Condom for vaginal drug delivery.

Kramzer LF, Cohen J, Schubert J, Dezzutti CS, Moncla BJ, Friend D, Rohan LC.

Contraception. 2015 Sep;92(3):254-60. doi: 10.1016/j.contraception.2015.05.005. Epub 2015 May 19.


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.

PLoS One. 2015 May 5;10(5):e0125363. doi: 10.1371/journal.pone.0125363. eCollection 2015.


The effect of menopause on the innate antiviral activity of cervicovaginal lavage.

Chappell CA, Isaacs CE, Xu W, Meyn LA, Uranker K, Dezzutti CS, Moncla BJ, Hillier SL.

Am J Obstet Gynecol. 2015 Aug;213(2):204.e1-6. doi: 10.1016/j.ajog.2015.03.045. Epub 2015 Mar 25.


Vaginal Microbicide Film Combinations of Two Reverse Transcriptase Inhibitors, EFdA and CSIC, for the Prevention of HIV-1 Sexual Transmission.

Zhang W, Hu M, Shi Y, Gong T, Dezzutti CS, Moncla B, Sarafianos SG, Parniak MA, Rohan LC.

Pharm Res. 2015 Sep;32(9):2960-72. doi: 10.1007/s11095-015-1678-2. Epub 2015 Mar 21.


Y chromosome and HIV DNA detection in vaginal swabs as biomarkers of semen and HIV exposure in women.

Penrose KJ, Richardson BA, Besson G, Dezzutti CS, Herold BC, Abdool Karim SS, Mellors JW, Parikh UM; MTN Biomedical Sciences Working Group and the HPTN 035 Protocol Team.

Sex Transm Dis. 2014 Nov;41(11):674-9. doi: 10.1097/OLQ.0000000000000191.


Extracts from Acacia catechu suppress HIV-1 replication by inhibiting the activities of the viral protease and Tat.

Nutan, Modi M, Dezzutti CS, Kulshreshtha S, Rawat AK, Srivastava SK, Malhotra S, Verma A, Ranga U, Gupta SK.

Virol J. 2013 Oct 18;10:309. doi: 10.1186/1743-422X-10-309.


Formulation and characterization of polymeric films containing combinations of antiretrovirals (ARVs) for HIV prevention.

Akil A, Agashe H, Dezzutti CS, Moncla BJ, Hillier SL, Devlin B, Shi Y, Uranker K, Rohan LC.

Pharm Res. 2015 Feb;32(2):458-68. doi: 10.1007/s11095-014-1474-4. Epub 2014 Jul 31.


HIV-1 specific IgA detected in vaginal secretions of HIV uninfected women participating in a microbicide trial in Southern Africa are primarily directed toward gp120 and gp140 specificities.

Seaton KE, Ballweber L, Lan A, Donathan M, Hughes S, Vojtech L, Moody MA, Liao HX, Haynes BF, Galloway CG, Richardson BA, Karim SA, Dezzutti CS, McElrath MJ, Tomaras GD, Hladik F.

PLoS One. 2014 Jul 23;9(7):e101863. doi: 10.1371/journal.pone.0101863. eCollection 2014.


Development of HIV-1 rectal-specific microbicides and colonic tissue evaluation.

Dezzutti CS, Russo J, Wang L, Abebe KZ, Li J, Friend DR, McGowan IM, Rohan LC.

PLoS One. 2014 Jul 15;9(7):e102585. doi: 10.1371/journal.pone.0102585. eCollection 2014.


Antiviral activity of genital tract secretions after oral or topical tenofovir pre-exposure prophylaxis for HIV-1.

Herold BC, Dezzutti CS, Richardson BA, Marrazzo J, Mesquita PM, Carpenter C, Huber A, Louissaint N, Marzinke MA, Hillier SL, Hendrix CW.

J Acquir Immune Defic Syndr. 2014 May 1;66(1):65-73. doi: 10.1097/QAI.0000000000000110.


Toward early safety alert endpoints: exploring biomarkers suggestive of microbicide failure.

Mauck CK, Lai JJ, Weiner DH, Chandra N, Fichorova RN, Dezzutti CS, Hillier SL, Archer DF, Creinin MD, Schwartz JL, Callahan MM, Doncel GF.

AIDS Res Hum Retroviruses. 2013 Nov;29(11):1475-86. doi: 10.1089/AID.2012.0345. Epub 2013 Aug 30.


HIV-1 infection of female genital tract tissue for use in prevention studies.

Dezzutti CS, Uranker K, Bunge KE, Richardson-Harman N, Macio I, Hillier SL.

J Acquir Immune Defic Syndr. 2013 Aug 15;63(5):548-54. doi: 10.1097/QAI.0b013e318291f331.


Use of human mucosal tissue to study HIV-1 pathogenesis and evaluate HIV-1 prevention modalities.

Dezzutti CS, Hladik F.

Curr HIV/AIDS Rep. 2013 Mar;10(1):12-20. doi: 10.1007/s11904-012-0148-2. Review.


Is wetter better? An evaluation of over-the-counter personal lubricants for safety and anti-HIV-1 activity.

Dezzutti CS, Brown ER, Moncla B, Russo J, Cost M, Wang L, Uranker K, Kunjara Na Ayudhya RP, Pryke K, Pickett J, Leblanc MA, Rohan LC.

PLoS One. 2012;7(11):e48328. doi: 10.1371/journal.pone.0048328. Epub 2012 Nov 7.


Mucosal Escherichia coli bactericidal activity and immune mediators are associated with HIV-1 seroconversion in women participating in the HPTN 035 trial.

Dezzutti CS, Richardson BA, Marrazzo JM, Tugetman J, Ramjee G, Taha T, Chirenje ZM, Abdool Karim SS, Hillier SL, Herold BC; MTN Biomedical Sciences Working Group; HPTN 035 Protocol Team.

J Infect Dis. 2012 Dec 15;206(12):1931-5. doi: 10.1093/infdis/jis555. Epub 2012 Sep 10.


Safety and efficacy of tenofovir/IQP-0528 combination gels - a dual compartment microbicide for HIV-1 prevention.

Dezzutti CS, Shetler C, Mahalingam A, Ugaonkar SR, Gwozdz G, Buckheit KW, Buckheit RW Jr.

Antiviral Res. 2012 Nov;96(2):221-5. doi: 10.1016/j.antiviral.2012.08.004. Epub 2012 Aug 23.


Sustained local delivery of structurally diverse HIV-1 microbicides released from sublimation enthalpy controlled matrices.

Gunaseelan S, Gallay PA, Bobardt MD, Dezzutti CS, Esch T, Maskiewicz R.

Pharm Res. 2012 Nov;29(11):3156-68. doi: 10.1007/s11095-012-0811-8. Epub 2012 Jun 27. Erratum in: Pharm Res. 2013 Mar;30(3):911.


Reformulated tenofovir gel for use as a dual compartment microbicide.

Dezzutti CS, Rohan LC, Wang L, Uranker K, Shetler C, Cost M, Lynam JD, Friend D.

J Antimicrob Chemother. 2012 Sep;67(9):2139-42. doi: 10.1093/jac/dks173. Epub 2012 May 11.


Characterization of UC781-tenofovir combination gel products for HIV-1 infection prevention in an ex vivo ectocervical model.

Cost M, Dezzutti CS, Clark MR, Friend DR, Akil A, Rohan LC.

Antimicrob Agents Chemother. 2012 Jun;56(6):3058-66. doi: 10.1128/AAC.06284-11. Epub 2012 Mar 19.


Sublimable C5A delivery provides sustained and prolonged anti-HIV microbicidal activities.

Maskiewicz R, Bobardt M, Chatterji U, Gunaseelan S, Dezzutti CS, Penin F, Gallay PA.

Antimicrob Agents Chemother. 2012 Jun;56(6):3336-43. doi: 10.1128/AAC.00186-12. Epub 2012 Mar 19.


Performance of swabs, lavage, and diluents to quantify biomarkers of female genital tract soluble mucosal mediators.

Dezzutti CS, Hendrix CW, Marrazzo JM, Pan Z, Wang L, Louissaint N, Kalyoussef S, Torres NM, Hladik F, Parikh U, Mellors J, Hillier SL, Herold BC.

PLoS One. 2011;6(8):e23136. doi: 10.1371/journal.pone.0023136. Epub 2011 Aug 12. Erratum in: PLoS One. 2012;7(1). doi:10.1371/annotation/7824df54-632a-48d6-bfbe-42d069d40c6e.

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