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Items: 36

1.

Index participant characteristics and HIV assisted partner services efficacy in Kenya: results of a cluster randomized trial.

Masyuko SJ, Cherutich PK, Contesse MG, Maingi PM, Wamuti BM, Macharia PM, Bukusi DE, Otieno FA, Spiegel HM, Dunbar MD, Golden MR, Richardson BA, Farquhar C.

J Int AIDS Soc. 2019 Jul;22 Suppl 3:e25305. doi: 10.1002/jia2.25305.

2.

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.

Lancet HIV. 2019 Aug;6(8):e498-e508. doi: 10.1016/S2352-3018(19)30145-6. Epub 2019 Jul 15.

PMID:
31320290
3.

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.

4.

Small for gestational age: Case definition & guidelines for data collection, analysis, and presentation of maternal immunisation safety data.

Schlaudecker EP, Munoz FM, Bardají A, Boghossian NS, Khalil A, Mousa H, Nesin M, Nisar MI, Pool V, Spiegel HML, Tapia MD, Kochhar S, Black S; Brighton Collaboration Small for Gestational Age Working Group.

Vaccine. 2017 Dec 4;35(48 Pt A):6518-6528. doi: 10.1016/j.vaccine.2017.01.040. No abstract available.

5.

Comparison of the Pharmacokinetics and Pharmacodynamics of Single-Dose Tenofovir Vaginal Film and Gel Formulation (FAME 05).

Robinson JA, Marzinke MA, Fuchs EJ, Bakshi RP, Spiegel HML, Coleman JS, Rohan LC, Hendrix CW.

J Acquir Immune Defic Syndr. 2018 Feb 1;77(2):175-182. doi: 10.1097/QAI.0000000000001587.

6.

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.

PLoS One. 2017 Jun 12;12(6):e0178075. doi: 10.1371/journal.pone.0178075. eCollection 2017.

7.

Comparison of Dapivirine Vaginal Gel and Film Formulation Pharmacokinetics and Pharmacodynamics (FAME 02B).

Robinson JA, Marzinke MA, Bakshi RP, Fuchs EJ, Radebaugh CL, Aung W, Spiegel HM, Coleman JS, Rohan LC, Hendrix CW.

AIDS Res Hum Retroviruses. 2017 Apr;33(4):339-346. doi: 10.1089/AID.2016.0040. Epub 2016 Dec 13.

8.

Safety and Efficacy of Atorvastatin in Human Immunodeficiency Virus-infected Children, Adolescents and Young Adults With Hyperlipidemia.

Melvin AJ, Montepiedra G, Aaron L, Meyer WA 3rd, Spiegel HM, Borkowsky W, Abzug MJ, Best BM, Crain MJ, Borum PR, Graham B, Anthony P, Shin K, Siberry GK; P1063 Study Team.

Pediatr Infect Dis J. 2017 Jan;36(1):53-60.

9.

Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women.

Jones CE, Munoz FM, Spiegel HM, Heininger U, Zuber PL, Edwards KM, Lambach P, Neels P, Kohl KS, Gidudu J, Hirschfeld S, Oleske JM, Khuri-Bulos N, Bauwens J, Eckert LO, Kochhar S, Bonhoeffer J, Heath PT; Brighton Collaboration Immunization in Pregnancy Working Group.

Vaccine. 2016 Dec 1;34(49):5998-6006. doi: 10.1016/j.vaccine.2016.07.032. Epub 2016 Jul 29.

10.

Cost-Effectiveness of Pre-exposure HIV Prophylaxis During Pregnancy and Breastfeeding in Sub-Saharan Africa.

Price JT, Wheeler SB, Stranix-Chibanda L, Hosek SG, Watts DH, Siberry GK, Spiegel HM, Stringer JS, Chi BH.

J Acquir Immune Defic Syndr. 2016 Aug 1;72 Suppl 2:S145-53. doi: 10.1097/QAI.0000000000001063.

11.

Feasibility of radiolabeled small molecule permeability as a quantitative measure of microbicide candidate toxicity.

Coleman JS, Fuchs E, Aung WS, Marzinke MA, Bakshi RP, Spiegel HML, Robinson J, Hendrix CW.

Contraception. 2016 Apr;93(4):331-336. doi: 10.1016/j.contraception.2016.01.002. Epub 2016 Jan 6.

12.

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.

13.

Lower HIV Risk Among Circumcised Men Who Have Sex With Men in China: Interaction With Anal Sex Role in a Cross-Sectional Study.

Qian HZ, Ruan Y, Liu Y, Milam DF, Spiegel HM, Yin L, Li D, Shepherd BE, Shao Y, Vermund SH.

J Acquir Immune Defic Syndr. 2016 Apr 1;71(4):444-51. doi: 10.1097/QAI.0000000000000856.

14.

Clinical Case Definitions for Classification of Intrathoracic Tuberculosis in Children: An Update.

Graham SM, Cuevas LE, Jean-Philippe P, Browning R, Casenghi M, Detjen AK, Gnanashanmugam D, Hesseling AC, Kampmann B, Mandalakas A, Marais BJ, Schito M, Spiegel HM, Starke JR, Worrell C, Zar HJ.

Clin Infect Dis. 2015 Oct 15;61Suppl 3:S179-87. doi: 10.1093/cid/civ581.

15.

A Blueprint to Address Research Gaps in the Development of Biomarkers for Pediatric Tuberculosis.

Nicol MP, Gnanashanmugam D, Browning R, Click ES, Cuevas LE, Detjen A, Graham SM, Levin M, Makhene M, Nahid P, Perez-Velez CM, Reither K, Song R, Spiegel HM, Worrell C, Zar HJ, Walzl G.

Clin Infect Dis. 2015 Oct 15;61Suppl 3:S164-72. doi: 10.1093/cid/civ613.

16.

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.

AIDS Res Hum Retroviruses. 2015 Nov;31(11):1098-108. doi: 10.1089/AID.2015.0098. Epub 2015 Aug 24.

17.

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.

18.

Predictors of resolution and persistence of renal laboratory abnormalities in pediatric HIV infection.

Mitchell CD, Chernoff MC, Seage GR 3rd, Purswani MU, Spiegel HM, Zilleruelo G, Abitbol C, Heckman B, Ponce CB, Oleske JM; IMPAACT 219/219C Study Team.

Pediatr Nephrol. 2015 Jan;30(1):153-65. doi: 10.1007/s00467-014-2909-1. Epub 2014 Aug 24.

19.

Nondisclosure of HIV status in adolescence.

Spiegel HM.

Adolesc Med State Art Rev. 2011 Aug;22(2):277-82, x. Review.

PMID:
22106741
20.

Prevalence of congenital anomalies in infants with in utero exposure to antiretrovirals.

Knapp KM, Brogly SB, Muenz DG, Spiegel HM, Conway DH, Scott GB, Talbot JT, Shapiro DE, Read JS.

Pediatr Infect Dis J. 2012 Feb;31(2):164-70. doi: 10.1097/INF.0b013e318235c7aa.

21.

Human parechovirus-3 infection: emerging pathogen in neonatal sepsis.

Levorson RE, Jantausch BA, Wiedermann BL, Spiegel HM, Campos JM.

Pediatr Infect Dis J. 2009 Jun;28(6):545-7. doi: 10.1097/INF.0b013e318194596a.

PMID:
19483524
22.

Adolescents and HIV: prevention and clinical care.

Spiegel HM, Futterman DC.

Curr HIV/AIDS Rep. 2009 May;6(2):100-7. Review.

PMID:
19358781
23.

Informing Adolescents of Perinatally Contracted HIV.

Spiegel HM, Futterman D.

Virtual Mentor. 2009 Dec 1;11(12):938-43. doi: 10.1001/virtualmentor.2009.11.12.ccas2-0912. No abstract available.

24.

Epidemiology of new cases of HIV-1 infection in children referred to the metropolitan pediatric hospital in Washington, DC.

Rakhmanina NY, Sill A, Baghdassarian A, Bruce K, Williams K, Castel AD, Rakusan T, Singh N, Spiegel HM.

Pediatr Infect Dis J. 2008 Sep;27(9):837-9. doi: 10.1097/INF.0b013e3181719fa5.

PMID:
18664925
25.

Nonlinear pharmacokinetics of high-dose recombinant fusion protein CD4-IgG2 (PRO 542) observed in HIV-1-infected children.

Fletcher CV, DeVille JG, Samson PM, Moye JH Jr, Church JA, Spiegel HM, Palumbo P, Fenton T, Smith ME, Graham B, Kraimer JM, Shearer WT; Pediatric AIDS Clinical Trials Group, Protocol 351 Study Group.

J Allergy Clin Immunol. 2007 Mar;119(3):747-50. No abstract available.

26.

Nevirapine concentration in nonstimulated saliva: an alternative to plasma sampling in children with human immunodeficiency virus infection.

Rakhmanina NY, Capparelli EV, van den Anker JN, Williams K, Sever JL, Spiegel HM, Soldin SJ.

Ther Drug Monit. 2007 Feb;29(1):110-7.

PMID:
17304158
27.

Susceptibility of pediatric HIV-1 isolates to recombinant CD4-IgG2 (PRO 542) and humanized mAb to the chemokine receptor CCR5 (PRO 140).

Shearer WT, DeVille JG, Samson PM, Moye JH Jr, Fletcher CV, Church JA, Spiegel HM, Palumbo P, Fenton T, Smith ME, Graham B, Kraimer JM, Olson WC.

J Allergy Clin Immunol. 2006 Aug;118(2):518-21. Epub 2006 May 19. No abstract available.

PMID:
16890780
28.

Therapeutic drug monitoring for patients with HIV infection: Children's National Medical Center, Washington DC experience.

Soldin SJ, Rakhmanina NY, Spiegel HM, Sever JL.

Ther Drug Monit. 2004 Apr;26(2):107-9.

PMID:
15228148
29.

HIV-specific CD8+ T cell function in children with vertically acquired HIV-1 infection is critically influenced by age and the state of the CD4+ T cell compartment.

Sandberg JK, Fast NM, Jordan KA, Furlan SN, Barbour JD, Fennelly G, Dobroszycki J, Spiegel HM, Wiznia A, Rosenberg MG, Nixon DF.

J Immunol. 2003 Apr 15;170(8):4403-10.

30.

A simple and rapid magnetic bead separation technique for the isolation of tetramer-positive virus-specific CD8 T cells.

McDermott AB, Spiegel HM, Irsch J, Ogg GS, Nixon DF.

AIDS. 2001 Apr 13;15(6):810-2. No abstract available.

PMID:
11371703
31.

Direct ex vivo measurement of CD8(+) T-lymphocyte responses to human parvovirus B19.

Tolfvenstam T, Oxenius A, Price DA, Shacklett BL, Spiegel HM, Hedman K, Norbeck O, Levi M, Olsen K, Kantzanou M, Nixon DF, Broliden K, Klenerman P.

J Virol. 2001 Jan;75(1):540-3.

32.

The impact of early initiation of highly active antiretroviral therapy on the human immunodeficiency virus type 1-specific CD8 T cell response in children.

Spiegel HM, Chandwani R, Sheehy ME, Dobroszycki J, Fennelly G, Wiznia A, Radding J, Rigaud M, Pollack H, Borkowsky W, Rosenberg M, Nixon DF.

J Infect Dis. 2000 Jul;182(1):88-95. Epub 2000 Jun 27.

PMID:
10882585
33.

HIV-specific CD8(+) T cells produce antiviral cytokines but are impaired in cytolytic function.

Appay V, Nixon DF, Donahoe SM, Gillespie GM, Dong T, King A, Ogg GS, Spiegel HM, Conlon C, Spina CA, Havlir DV, Richman DD, Waters A, Easterbrook P, McMichael AJ, Rowland-Jones SL.

J Exp Med. 2000 Jul 3;192(1):63-75.

34.

Human immunodeficiency virus type 1- and cytomegalovirus-specific cytotoxic T lymphocytes can persist at high frequency for prolonged periods in the absence of circulating peripheral CD4(+) T cells.

Spiegel HM, Ogg GS, DeFalcon E, Sheehy ME, Monard S, Haslett PA, Gillespie G, Donahoe SM, Pollack H, Borkowsky W, McMichael AJ, Nixon DF.

J Virol. 2000 Jan;74(2):1018-22.

35.

A polymorphism in the regulatory region of the CC-chemokine receptor 5 gene influences perinatal transmission of human immunodeficiency virus type 1 to African-American infants.

Kostrikis LG, Neumann AU, Thomson B, Korber BT, McHardy P, Karanicolas R, Deutsch L, Huang Y, Lew JF, McIntosh K, Pollack H, Borkowsky W, Spiegel HM, Palumbo P, Oleske J, Bardeguez A, Luzuriaga K, Sullivan J, Wolinsky SM, Koup RA, Ho DD, Moore JP.

J Virol. 1999 Dec;73(12):10264-71.

36.

Changes in frequency of HIV-1-specific cytotoxic T cell precursors and circulating effectors after combination antiretroviral therapy in children.

Spiegel HM, DeFalcon E, Ogg GS, Larsson M, Beadle TJ, Tao P, McMichael AJ, Bhardwaj N, O'Callaghan C, Cox WI, Krasinski K, Pollack H, Borkowsky W, Nixon DF.

J Infect Dis. 1999 Aug;180(2):359-68.

PMID:
10395850

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