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Aberrant cervical innate immunity predicts onset of dysbiosis and sexually transmitted infections in women of reproductive age.

Fichorova RN, Morrison CS, Chen PL, Yamamoto HS, Govender Y, Junaid D, Ryan S, Kwok C, Chipato T, Salata RA, Doncel GF.

PLoS One. 2020 Jan 8;15(1):e0224359. doi: 10.1371/journal.pone.0224359. eCollection 2020.


Efficacy is Not Everything: Eliciting Women's Preferences for a Vaginal HIV Prevention Product Using a Discrete-Choice Experiment.

Browne EN, Montgomery ET, Mansfield C, Boeri M, Mange B, Beksinska M, Schwartz JL, Clark MR, Doncel GF, Smit J, Chirenje ZM, van der Straten A.

AIDS Behav. 2019 Nov 6. doi: 10.1007/s10461-019-02715-1. [Epub ahead of print]


Integrated provision of topical pre-exposure prophylaxis in routine family planning services in South Africa: a non-inferiority randomized controlled trial.

Mansoor LE, Yende-Zuma N, Baxter C, Mngadi KT, Dawood H, Gengiah TN, Samsunder N, Schwartz JL, Doncel GF, Abdool Karim Q.

J Int AIDS Soc. 2019 Sep;22(9):e25381. doi: 10.1002/jia2.25381.


A phase I randomized safety study of a single-size silicone rubber diaphragm used with or without a lactic-acid-containing diaphragm gel.

Thurman A, Cunningham T, Fichorova R, Herold BC, Hillier SL, Chandra N, Doncel GF.

Contraception. 2019 Dec;100(6):430-437. doi: 10.1016/j.contraception.2019.06.004. Epub 2019 Aug 21.


Topical Inserts: A Versatile Delivery Form for HIV Prevention.

Peet MM, Agrahari V, Anderson SM, Hanif H, Singh ON, Thurman AR, Doncel GF, Clark MR.

Pharmaceutics. 2019 Aug 1;11(8). pii: E374. doi: 10.3390/pharmaceutics11080374. Review.


Vaginal microbiota and mucosal pharmacokinetics of tenofovir in healthy women using tenofovir and tenofovir/levonorgestrel vaginal rings.

Thurman AR, Schwartz JL, Ravel J, Gajer P, Marzinke MA, Yousefieh N, Anderson SM, Doncel GF.

PLoS One. 2019 May 20;14(5):e0217229. doi: 10.1371/journal.pone.0217229. eCollection 2019.


End-user preference for and choice of four vaginally delivered HIV prevention methods among young women in South Africa and Zimbabwe: the Quatro Clinical Crossover Study.

Montgomery ET, Beksinska M, Mgodi N, Schwartz J, Weinrib R, Browne EN, Mphili N, Musara P, Jaggernath M, Ju S, Smit J, Chirenje ZM, Doncel GF, van der Straten A.

J Int AIDS Soc. 2019 May;22(5):e25283. doi: 10.1002/jia2.25283.


The Effect of Hormonal Contraception on Cervicovaginal Mucosal End Points Associated with HIV Acquisition.

Thurman A, Chandra N, Schwartz JL, Brache V, Chen BA, Asin S, Rollenhagen C, Herold BC, Fichorova RN, Hillier SL, Weiner DH, Mauck C, Doncel GF.

AIDS Res Hum Retroviruses. 2019 Sep;35(9):853-864. doi: 10.1089/AID.2018.0298. Epub 2019 May 14.


Development of a Transdermal Delivery System for Tenofovir Alafenamide, a Prodrug of Tenofovir with Potent Antiviral Activity Against HIV and HBV.

Puri A, Bhattaccharjee SA, Zhang W, Clark M, Singh O, Doncel GF, Banga AK.

Pharmaceutics. 2019 Apr 9;11(4). pii: E173. doi: 10.3390/pharmaceutics11040173.


Seminal exosomes and HIV-1 transmission.

Ouattara LA, Anderson SM, Doncel GF.

Andrologia. 2018 Dec;50(11):e13220. doi: 10.1111/and.13220. Review.


Tenofovir 1% vaginal gel for prevention of HIV-1 infection in women in South Africa (FACTS-001): a phase 3, randomised, double-blind, placebo-controlled trial.

Delany-Moretlwe S, Lombard C, Baron D, Bekker LG, Nkala B, Ahmed K, Sebe M, Brumskine W, Nchabeleng M, Palanee-Philips T, Ntshangase J, Sibiya S, Smith E, Panchia R, Myer L, Schwartz JL, Marzinke M, Morris L, Brown ER, Doncel GF, Gray G, Rees H.

Lancet Infect Dis. 2018 Nov;18(11):1241-1250. doi: 10.1016/S1473-3099(18)30428-6. Epub 2018 Oct 24.


Development and clinical assessment of new objective adherence markers for four microbicide delivery systems used in HIV prevention studies.

Jacot TA, Clark MR, Adedipe OE, Godbout S, Peele AG, Ju S, Schwartz JL, Thurman AR, Doncel GF.

Clin Transl Med. 2018 Nov 7;7(1):37. doi: 10.1186/s40169-018-0213-6.


Use of contraceptive depot medroxyprogesterone acetate is associated with impaired cervicovaginal mucosal integrity.

Zalenskaya IA, Chandra N, Yousefieh N, Fang X, Adedipe OE, Jackson SS, Anderson SM, Mauck CK, Schwartz JL, Thurman AR, Doncel GF.

J Clin Invest. 2018 Oct 1;128(10):4622-4638. doi: 10.1172/JCI120583. Epub 2018 Sep 17.


Effect of Hormonal Contraception on Pharmacokinetics of Vaginal Tenofovir in Healthy Women: Increased Tenofovir Diphosphate in Injectable Depot Medroxyprogesterone Acetate Users.

Thurman AR, Schwartz JL, Brache V, Chen BA, Chandra N, Kashuba ADM, Weiner DH, Mauck C, Doncel GF.

J Acquir Immune Defic Syndr. 2019 Jan 1;80(1):79-88. doi: 10.1097/QAI.0000000000001864.


A Longitudinal Assessment of Cervical Inflammation and Immunity Associated with HIV-1 Infection, Hormonal Contraception, and Pregnancy.

Morrison CS, Fichorova R, Chen PL, Kwok C, Deese J, Yamamoto H, Anderson S, Chipato T, Salata R, Doncel GF.

AIDS Res Hum Retroviruses. 2018 Oct;34(10):889-899. doi: 10.1089/AID.2018.0022. Epub 2018 Sep 5.


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.


Rapid measures of user's adherence to vaginal drug products using attenuated total reflectance Fourier transform infrared spectroscopy (ATR-FTIR) and multivariate discriminant techniques.

Adedipe OE, Jacot TA, Thurman AR, Doncel GF, Clark MR.

PLoS One. 2018 May 25;13(5):e0197906. doi: 10.1371/journal.pone.0197906. eCollection 2018.


Differences in Local and Systemic TFV PK Among Premenopausal Versus Postmenopausal Women Exposed to TFV 1% Vaginal Gel.

Thurman AR, Chandra N, Yousefieh N, Kimble T, Anderson SM, Cottrell M, Sykes C, Kashuba A, Schwartz JL, Doncel GF.

J Acquir Immune Defic Syndr. 2018 May 1;78(1):82-92. doi: 10.1097/QAI.0000000000001648.


A phase I randomized postcoital testing and safety study of the Caya diaphragm used with 3% Nonoxynol-9 gel, ContraGel or no gel.

Mauck CK, Brache V, Kimble T, Thurman A, Cochon L, Littlefield S, Linton K, Doncel GF, Schwartz JL.

Contraception. 2017 Aug;96(2):124-130. doi: 10.1016/j.contraception.2017.05.016. Epub 2017 Jun 9.


Comparison of Mucosal Markers of Human Immunodeficiency Virus Susceptibility in Healthy Premenopausal Versus Postmenopausal Women.

Thurman AR, Yousefieh N, Chandra N, Kimble T, Asin S, Rollenhagen C, Anderson SM, Herold BC, Freiermuth JL, Starkman BS, Mesquita PMM, Richardson-Harman N, Cunningham T, Hillier S, Rabe L, Schwartz JL, Doncel GF.

AIDS Res Hum Retroviruses. 2017 Aug;33(8):807-819. doi: 10.1089/AID.2016.0320. Epub 2017 May 16.


Synthesis and anti-HIV activities of unsymmetrical long chain dicarboxylate esters of dinucleoside reverse transcriptase inhibitors.

Agarwal HK, Chhikara BS, Doncel GF, Parang K.

Bioorg Med Chem Lett. 2017 May 1;27(9):1934-1937. doi: 10.1016/j.bmcl.2017.03.031. Epub 2017 Mar 16.


Assessment of the vaginal residence time of biomarkers of semen exposure.

Thurman A, Jacot T, Melendez J, Kimble T, Snead M, Jamshidi R, Wheeless A, Archer DF, Doncel GF, Mauck C.

Contraception. 2016 Nov;94(5):512-520. doi: 10.1016/j.contraception.2016.05.012. Epub 2016 May 31.


Comparison of Follicular and Luteal Phase Mucosal Markers of HIV Susceptibility in Healthy Women.

Thurman AR, Chandra N, Yousefieh N, Zalenskaya I, Kimble T, Asin S, Rollenhagen C, Anderson SM, Herold B, Mesquita PM, Richardson-Harman N, Cunningham T, Schwartz JL, Doncel GF.

AIDS Res Hum Retroviruses. 2016 Jun;32(6):547-60. doi: 10.1089/AID.2015.0264. Epub 2016 Feb 10.


Biomarkers of Cervical Inflammation and Immunity Associated with Cervical Shedding of HIV-1.

Mauck C, Chen PL, Morrison CS, Fichorova RN, Kwok C, Chipato T, Salata RA, Doncel GF.

AIDS Res Hum Retroviruses. 2016 May;32(5):443-51. doi: 10.1089/AID.2015.0088. Epub 2016 Jan 26.


Multipurpose Prevention Approaches with Antiretroviral-Based Formulations.

Jean-Pierre N, Barnable P, Kizima L, Rodríguez A, Seidor S, Cooney ML, Clark MR, Doncel GF, Robbiani M, Zydowsky TM, Teleshova N, Fernández-Romero JA.

Antimicrob Agents Chemother. 2015 Nov 23;60(2):1141-4. doi: 10.1128/AAC.02468-15. Print 2016 Feb.


Blocking CXCL9 Decreases HIV-1 Replication and Enhances the Activity of Prophylactic Antiretrovirals in Human Cervical Tissues.

Macura SL, Lathrop MJ, Gui J, Doncel GF, Asin SN, Rollenhagen C.

J Acquir Immune Defic Syndr. 2016 Apr 15;71(5):474-82. doi: 10.1097/QAI.0000000000000891.


The Contribution of Cervicovaginal Infections to the Immunomodulatory Effects of Hormonal Contraception.

Fichorova RN, Chen PL, Morrison CS, Doncel GF, Mendonca K, Kwok C, Chipato T, Salata R, Mauck C.

mBio. 2015 Sep 1;6(5):e00221-15. doi: 10.1128/mBio.00221-15.


Enhancing Interferon Regulatory Factor 7 Mediated Antiviral Responses and Decreasing Nuclear Factor Kappa B Expression Limit HIV-1 Replication in Cervical Tissues.

Rollenhagen C, Macura SL, Lathrop MJ, Mackenzie TA, Doncel GF, Asin SN.

PLoS One. 2015 Jun 29;10(6):e0131919. doi: 10.1371/journal.pone.0131919. eCollection 2015. Erratum in: PLoS One. 2015;10(7):e0133815. Rollenhage, Christiane [corrected to Rollenhagen, Christiane].


Gene Expression Profiling of Human Vaginal Cells In Vitro Discriminates Compounds with Pro-Inflammatory and Mucosa-Altering Properties: Novel Biomarkers for Preclinical Testing of HIV Microbicide Candidates.

Zalenskaya IA, Joseph T, Bavarva J, Yousefieh N, Jackson SS, Fashemi T, Yamamoto HS, Settlage R, Fichorova RN, Doncel GF.

PLoS One. 2015 Jun 8;10(6):e0128557. doi: 10.1371/journal.pone.0128557. eCollection 2015.


A quantitative multiplex nuclease protection assay reveals immunotoxicity gene expression profiles in the rabbit model for vaginal drug safety evaluation.

Fichorova RN, Mendonca K, Yamamoto HS, Murray R, Chandra N, Doncel GF.

Toxicol Appl Pharmacol. 2015 Jun 15;285(3):198-206. doi: 10.1016/j.taap.2015.02.017. Epub 2015 Mar 25.


Lack of in vitro-in vivo correlation for a UC781-releasing vaginal ring in macaques.

McConville C, Smith JM, McCoy CF, Srinivasan P, Mitchell J, Holder A, Otten RA, Butera S, Doncel GF, Friend DR, Malcolm RK.

Drug Deliv Transl Res. 2015 Feb;5(1):27-37. doi: 10.1007/s13346-015-0216-4.


Comparison of visual and ultraviolet light inspection versus DNA/protein biomarkers to assess product adherence with vaginal microbicide applicators.

Thurman AR, Jacot TA, Kimble TD, Mauck C, Nelson A, Schwartz JL, Doncel GF.

Sex Transm Dis. 2014 Dec;41(12):739-46. doi: 10.1097/OLQ.0000000000000209.


Design, synthesis, antiviral activity, and pre-formulation development of poly-L-arginine-fatty acyl derivatives of nucleoside reverse transcriptase inhibitors.

Pemmaraju BP, Malekar S, Agarwal HK, Tiwari RK, Oh D, Doncel GF, Worthen DR, Parang K.

Nucleosides Nucleotides Nucleic Acids. 2015;34(1):1-15. doi: 10.1080/15257770.2014.945649.


Evaluation of Rapidly Disintegrating Vaginal Tablets of Tenofovir, Emtricitabine and Their Combination for HIV-1 Prevention.

Clark MR, Peet MM, Davis S, Doncel GF, Friend DR.

Pharmaceutics. 2014 Dec 8;6(4):616-631.


Development of a composite measure of product adherence, protocol compliance, and semen exposure using DNA and protein biomarkers for topical HIV prevention studies.

Jacot TA, Nelson A, Thurman A, Kashuba AD, Archer DF, Doncel GF.

PLoS One. 2014 Dec 9;9(12):e114368. doi: 10.1371/journal.pone.0114368. eCollection 2014.


Anti-HIV activities of precisely defined, semirigid, carboxylated alternating copolymers.

Savage AM, Li Y, Matolyak LE, Doncel GF, Turner SR, Gandour RD.

J Med Chem. 2014 Aug 14;57(15):6354-63. doi: 10.1021/jm401913w. Epub 2014 Jul 25.


Does tenofovir gel or do other microbicide products affect detection of biomarkers of semen exposure in vitro?

Snead MC, Kourtis AP, Melendez JH, Black CM, Mauck CK, Penman-Aguilar A, Chaney DM, Gallo MF, Jamieson DJ, Macaluso M, Doncel GF.

Contraception. 2014 Aug;90(2):136-41. doi: 10.1016/j.contraception.2014.03.009. Epub 2014 Mar 25.


Role of semen in modulating the female genital tract microenvironment--implications for HIV transmission.

Doncel GF, Anderson S, Zalenskaya I.

Am J Reprod Immunol. 2014 Jun;71(6):564-74. doi: 10.1111/aji.12231. Epub 2014 Apr 7. Review.


Pharmacokinetic and safety analyses of tenofovir and tenofovir-emtricitabine vaginal tablets in pigtailed macaques.

Pereira LE, Clark MR, Friend DR, Garber DA, McNicholl JM, Hendry RM, Doncel GF, Smith JM.

Antimicrob Agents Chemother. 2014 May;58(5):2665-74. doi: 10.1128/AAC.02336-13. Epub 2014 Feb 24.


Effects of hormonal contraception on antiretroviral drug metabolism, pharmacokinetics and pharmacodynamics.

Thurman AR, Anderson S, Doncel GF.

Am J Reprod Immunol. 2014 Jun;71(6):523-30. doi: 10.1111/aji.12210. Epub 2014 Feb 13. Review.


Herpes simplex virus type-2 stimulates HIV-1 replication in cervical tissues: implications for HIV-1 transmission and efficacy of anti-HIV-1 microbicides.

Rollenhagen C, Lathrop MJ, Macura SL, Doncel GF, Asin SN.

Mucosal Immunol. 2014 Sep;7(5):1165-74. doi: 10.1038/mi.2014.3. Epub 2014 Feb 5.


Cervical inflammation and immunity associated with hormonal contraception, pregnancy, and HIV-1 seroconversion.

Morrison C, Fichorova RN, Mauck C, Chen PL, Kwok C, Chipato T, Salata R, Doncel GF.

J Acquir Immune Defic Syndr. 2014 Jun 1;66(2):109-17. doi: 10.1097/QAI.0000000000000103.


Effect of lubricants and a vaginal spermicide gel on the detection of prostate specific antigen, a biomarker of semen exposure, using a quantitative (Abbott ARCHITECT) assay.

Snead MC, Melendez JH, Kourtis AP, Chaney DM, Brown TM, Black CM, Mauck CK, Schwartz JL, Zenilman JM, Jamieson DJ, Macaluso M, Doncel GF.

Contraception. 2014 Feb;89(2):134-8. doi: 10.1016/j.contraception.2013.09.016. Epub 2013 Nov 12.


Intravaginal rings as delivery systems for microbicides and multipurpose prevention technologies.

Thurman AR, Clark MR, Hurlburt JA, Doncel GF.

Int J Womens Health. 2013 Oct 21;5:695-708. doi: 10.2147/IJWH.S34030. Review.


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.


TSPY4 is a novel sperm-specific biomarker of semen exposure in human cervicovaginal fluids; potential use in HIV prevention and contraception studies.

Jacot TA, Zalenskaya I, Mauck C, Archer DF, Doncel GF.

Contraception. 2013 Sep;88(3):387-95. doi: 10.1016/j.contraception.2012.11.022. Epub 2012 Dec 7.


Twice-daily application of HIV microbicides alter the vaginal microbiota.

Ravel J, Gajer P, Fu L, Mauck CK, Koenig SS, Sakamoto J, Motsinger-Reif AA, Doncel GF, Zeichner SL.

mBio. 2012 Dec 18;3(6). pii: e00370-12. doi: 10.1128/mBio.00370-12.


Depot medroxyprogesterone acetate increases immune cell numbers and activation markers in human vaginal mucosal tissues.

Chandra N, Thurman AR, Anderson S, Cunningham TD, Yousefieh N, Mauck C, Doncel GF.

AIDS Res Hum Retroviruses. 2013 Mar;29(3):592-601. doi: 10.1089/aid.2012.0271. Epub 2012 Nov 28.


Seminal plasma induces prostaglandin-endoperoxide synthase (PTGS) 2 expression in immortalized human vaginal cells: involvement of semen prostaglandin E2 in PTGS2 upregulation.

Joseph T, Zalenskaya IA, Sawyer LC, Chandra N, Doncel GF.

Biol Reprod. 2013 Jan 17;88(1):13. doi: 10.1095/biolreprod.112.101956. Print 2013 Jan.


Herpes simplex virus and HIV: genital infection synergy and novel approaches to dual prevention.

Thurman AR, Doncel GF.

Int J STD AIDS. 2012 Sep;23(9):613-9. doi: 10.1258/ijsa.2012.011356. Review.


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