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Items: 37

1.

A Phase 1, Randomized, Single-Ascending-Dose Study To Investigate the Safety, Tolerability, and Pharmacokinetics of DSTA4637S, an Anti-Staphylococcus aureus Thiomab Antibody-Antibiotic Conjugate, in Healthy Volunteers.

Peck M, Rothenberg ME, Deng R, Lewin-Koh N, She G, Kamath AV, Carrasco-Triguero M, Saad O, Castro A, Teufel L, Dickerson DS, Leonardelli M, Tavel JA.

Antimicrob Agents Chemother. 2019 May 24;63(6). pii: e02588-18. doi: 10.1128/AAC.02588-18. Print 2019 Jun.

PMID:
30910894
2.

Correlation of Cytomegalovirus (CMV) Disease Severity and Mortality With CMV Viral Burden in CMV-Seropositive Donor and CMV-Seronegative Solid Organ Transplant Recipients.

McBride JM, Sheinson D, Jiang J, Lewin-Koh N, Werner BG, Chow JKL, Wu X, Tavel JA, Snydman DR.

Open Forum Infect Dis. 2019 Jan 14;6(2):ofz003. doi: 10.1093/ofid/ofz003. eCollection 2019 Feb.

3.

Reply to Hunsberger and Memoli, "Efficacy Analysis in Healthy-Volunteer Influenza Challenge Trials: Intention To Treat".

McBride JM, Lim JJ, Burgess T, Deng R, Derby MA, Maia M, Horn P, Siddiqui O, Sheinson D, Chen-Harris H, Newton EM, Fillos D, Nazzal D, Rosenberger CM, Ohlson MB, Lambkin-Williams R, Fathi H, Harris JM, Tavel JA.

Antimicrob Agents Chemother. 2017 Dec 21;62(1). pii: e02034-17. doi: 10.1128/AAC.02034-17. Print 2018 Jan. No abstract available.

4.

Pharmacokinetics and Exposure-Response Analysis of RG7667, a Combination of Two Anticytomegalovirus Monoclonal Antibodies, in a Phase 2a Randomized Trial To Prevent Cytomegalovirus Infection in High-Risk Kidney Transplant Recipients.

Deng R, Wang Y, Maia M, Burgess T, McBride JM, Liao XC, Tavel JA, Hanley WD.

Antimicrob Agents Chemother. 2018 Jan 25;62(2). pii: e01108-17. doi: 10.1128/AAC.01108-17. Print 2018 Feb.

5.

Phase 2 Randomized Trial of the Safety and Efficacy of MHAA4549A, a Broadly Neutralizing Monoclonal Antibody, in a Human Influenza A Virus Challenge Model.

McBride JM, Lim JJ, Burgess T, Deng R, Derby MA, Maia M, Horn P, Siddiqui O, Sheinson D, Chen-Harris H, Newton EM, Fillos D, Nazzal D, Rosenberger CM, Ohlson MB, Lambkin-Williams R, Fathi H, Harris JM, Tavel JA.

Antimicrob Agents Chemother. 2017 Oct 24;61(11). pii: e01154-17. doi: 10.1128/AAC.01154-17. Print 2017 Nov.

6.

Pharmacokinetics of MHAA4549A, an Anti-Influenza A Monoclonal Antibody, in Healthy Subjects Challenged with Influenza A Virus in a Phase IIa Randomized Trial.

Deng R, Lee AP, Maia M, Lim JJ, Burgess T, Horn P, Derby MA, Newton E, Tavel JA, Hanley WD.

Clin Pharmacokinet. 2018 Mar;57(3):367-377. doi: 10.1007/s40262-017-0564-y.

PMID:
28639229
7.

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study To Investigate the Safety, Tolerability, and Pharmacokinetics of an Anti-Influenza B Virus Monoclonal Antibody, MHAB5553A, in Healthy Volunteers.

Lim JJ, Derby MA, Zhang Y, Deng R, Larouche R, Anderson M, Maia M, Carrier S, Pelletier I, Girard J, Kulkarni P, Newton E, Tavel JA.

Antimicrob Agents Chemother. 2017 Jul 25;61(8). pii: e00279-17. doi: 10.1128/AAC.00279-17. Print 2017 Aug.

8.

Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of RG7667, a Combination Monoclonal Antibody, for Prevention of Cytomegalovirus Infection in High-Risk Kidney Transplant Recipients.

Ishida JH, Patel A, Mehta AK, Gatault P, McBride JM, Burgess T, Derby MA, Snydman DR, Emu B, Feierbach B, Fouts AE, Maia M, Deng R, Rosenberger CM, Gennaro LA, Striano NS, Liao XC, Tavel JA.

Antimicrob Agents Chemother. 2017 Jan 24;61(2). pii: e01794-16. doi: 10.1128/AAC.01794-16. Print 2017 Feb.

9.

Two Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Studies To Investigate the Safety, Tolerability, and Pharmacokinetics of an Anti-Influenza A Virus Monoclonal Antibody, MHAA4549A, in Healthy Volunteers.

Lim JJ, Deng R, Derby MA, Larouche R, Horn P, Anderson M, Maia M, Carrier S, Pelletier I, Burgess T, Kulkarni P, Newton E, Tavel JA.

Antimicrob Agents Chemother. 2016 Aug 22;60(9):5437-44. doi: 10.1128/AAC.00607-16. Print 2016 Sep.

10.

Phase 1 Randomized, Double-Blind, Placebo-Controlled Study of RG7667, an Anticytomegalovirus Combination Monoclonal Antibody Therapy, in Healthy Adults.

Ishida JH, Burgess T, Derby MA, Brown PA, Maia M, Deng R, Emu B, Feierbach B, Fouts AE, Liao XC, Tavel JA.

Antimicrob Agents Chemother. 2015 Aug;59(8):4919-29. doi: 10.1128/AAC.00523-15. Epub 2015 Jun 8.

11.

Randomized study of danoprevir/ritonavir-based therapy for HCV genotype 1 patients with prior partial or null responses to peginterferon/ribavirin.

Feld JJ, Jacobson IM, Jensen DM, Foster GR, Pol S, Tam E, Jablkowski M, Berak H, Vierling JM, Yoshida EM, Perez-Gomez HR, Scalori A, Hooper GJ, Tavel JA, Navarro MT, Shahdad S, Kulkarni R, Le Pogam S, Nájera I, Eng S, Lim CY, Shulman NS, Yetzer ES.

J Hepatol. 2015 Feb;62(2):294-302. doi: 10.1016/j.jhep.2014.09.013. Epub 2014 Sep 18.

PMID:
25239078
12.

Protocol Development Program: A Novel Approach to Overcoming Barriers to Clinical Research.

Miller TJ, Sevastita VS, Chaitt DG, Tavel JA, Pierson JF.

Monitor (Assoc Clin Pharmacol). 2013 Feb 1;27(1):54-61. No abstract available.

13.

Pre-ART levels of inflammation and coagulation markers are strong predictors of death in a South African cohort with advanced HIV disease.

Ledwaba L, Tavel JA, Khabo P, Maja P, Qin J, Sangweni P, Liu X, Follmann D, Metcalf JA, Orsega S, Baseler B, Neaton JD, Lane HC; Project Phidisa Biomarkers Team.

PLoS One. 2012;7(3):e24243. doi: 10.1371/journal.pone.0024243. Epub 2012 Mar 20.

14.

What are biomarkers?

Strimbu K, Tavel JA.

Curr Opin HIV AIDS. 2010 Nov;5(6):463-6. doi: 10.1097/COH.0b013e32833ed177. Review.

15.

Interferon-alpha produces significant decreases in HIV load.

Tavel JA, Huang CY, Shen J, Metcalf JA, Dewar R, Shah A, Vasudevachari MB, Follmann DA, Herpin B, Davey RT, Polis MA, Kovacs J, Masur H, Lane HC.

J Interferon Cytokine Res. 2010 Jul;30(7):461-4. doi: 10.1089/jir.2009.0090.

16.

Effects of intermittent IL-2 alone or with peri-cycle antiretroviral therapy in early HIV infection: the STALWART study.

Tavel JA; INSIGHT STALWART Study Group, Babiker A, Fox L, Gey D, Lopardo G, Markowitz N, Paton N, Wentworth D, Wyman N.

PLoS One. 2010 Feb 23;5(2):e9334. doi: 10.1371/journal.pone.0009334.

17.

CD4 T cell survival after intermittent interleukin-2 therapy is predictive of an increase in the CD4 T cell count of HIV-infected patients.

Read SW, Lempicki RA, Di Mascio M, Srinivasula S, Burke R, Sachau W, Bosche M, Adelsberger JW, Sereti I, Davey RT Jr, Tavel JA, Huang CY, Issaq HJ, Fox SD, Lane H, Kovacs JA.

J Infect Dis. 2008 Sep 15;198(6):843-50. doi: 10.1086/591250.

18.

Bovine apolipoprotein B-100 is a dominant immunogen in therapeutic cell populations cultured in fetal calf serum in mice and humans.

Sakamoto N, Tsuji K, Muul LM, Lawler AM, Petricoin EF, Candotti F, Metcalf JA, Tavel JA, Lane HC, Urba WJ, Fox BA, Varki A, Lunney JK, Rosenberg AS.

Blood. 2007 Jul 15;110(2):501-8. Epub 2007 Mar 29.

19.

Safety and immunogenicity of a Gag-Pol candidate HIV-1 DNA vaccine administered by a needle-free device in HIV-1-seronegative subjects.

Tavel JA, Martin JE, Kelly GG, Enama ME, Shen JM, Gomez PL, Andrews CA, Koup RA, Bailer RT, Stein JA, Roederer M, Nabel GJ, Graham BS.

J Acquir Immune Defic Syndr. 2007 Apr 15;44(5):601-5.

20.

Post-trial access to tested interventions: the views of IRB/REC chair, investigators, and research participants in a multinational HIV/AIDS study.

Pace C, Grady C, Wendler D, Bebchuk JD, Tavel JA, McNay LA, Forster HP, Killen J, Emanuel EJ.

AIDS Res Hum Retroviruses. 2006 Sep;22(9):837-41.

PMID:
16989607
21.

A randomised trial of subcutaneous intermittent interleukin-2 without antiretroviral therapy in HIV-infected patients: the UK-Vanguard Study.

Youle M, Emery S, Fisher M, Nelson M, Fosdick L, Janossy G, Loveday C, Sullivan A, Herzmann C, Wand H, Davey RT Jr, Johnson MA, Tavel JA, Lane HC.

PLoS Clin Trials. 2006 May;1(1):e3. Epub 2006 May 19. Erratum in: PLoS Clin Trials. 2007 May;2(5):e23.

22.

Informed consent: practices and views of investigators in a multinational clinical trial.

Sabik L, Pace CA, Forster-Gertner HP, Wendler D, Bebchuk JD, Tavel JA, McNay LA, Killen J, Emanuel EJ, Grady C.

IRB. 2005 Sep-Oct;27(5):13-8. No abstract available.

PMID:
16425476
23.

Preferential survival of CD4+ T lymphocytes engineered with anti-human immunodeficiency virus (HIV) genes in HIV-infected individuals.

Morgan RA, Walker R, Carter CS, Natarajan V, Tavel JA, Bechtel C, Herpin B, Muul L, Zheng Z, Jagannatha S, Bunnell BA, Fellowes V, Metcalf JA, Stevens R, Baseler M, Leitman SF, Read EJ, Blaese RM, Lane HC.

Hum Gene Ther. 2005 Sep;16(9):1065-74.

PMID:
16149905
24.

The quality of informed consent in a clinical research study in Thailand.

Pace C, Emanuel EJ, Chuenyam T, Duncombe C, Bebchuk JD, Wendler D, Tavel JA, McNay LA, Phanuphak P, Forster HP, Grady C.

IRB. 2005 Jan-Feb;27(1):9-17. No abstract available.

PMID:
15835065
25.

CD4 cell response to 3 doses of subcutaneous interleukin 2: meta-analysis of 3 Vanguard studies.

Arduino RC, Nannini EC, Rodriguez-Barradas M, Schrader S, Losso M, Ruxrungtham K, Allende MC, Emery S, Fosdick L, Neaton J, Tavel JA, Davey RT, Lane HC; Evaluation of Subcutaneous Proleukin in a Randomized International Trial (ESPRIT) Vanguard Group; ESPRIT Executive Committee.

Clin Infect Dis. 2004 Jul 1;39(1):115-22. Epub 2004 Jun 14.

PMID:
15206062
26.

Antiretroviral drug content in products from developing countries.

Penzak SR, Acosta EP, Turner M, Tavel JA, Masur H.

Clin Infect Dis. 2004 May 1;38(9):1317-9. Epub 2004 Apr 14.

PMID:
15127347
27.

Induction and maintenance therapy with intermittent interleukin-2 in HIV-1 infection.

Farel CE, Chaitt DG, Hahn BK, Tavel JA, Kovacs JA, Polis MA, Masur H, Follmann DA, Lane HC, Davey RT Jr.

Blood. 2004 May 1;103(9):3282-6. Epub 2004 Jan 15.

PMID:
14726376
28.

A randomized, double-blinded, placebo-controlled trial of intermittent administration of interleukin-2 and prednisone in subjects infected with human immunodeficiency virus.

Tavel JA, Sereti I, Walker RE, Hahn B, Kovacs JA, Jagannatha S, Davey RT Jr, Falloon J, Polis MA, Masur H, Metcalf JA, Stevens R, Rupert A, Baseler M, Lane HC.

J Infect Dis. 2003 Aug 15;188(4):531-6. Epub 2003 Jul 31.

PMID:
12898439
29.

Analysis of generic nevirapine products in developing countries.

Penzak SR, Acosta EP, Turner M, Tavel JA, Masur H.

JAMA. 2003 May 28;289(20):2648-9. No abstract available.

PMID:
12771111
30.

Therapeutic use of interleukin-2 in HIV-infected patients.

Pau AK, Tavel JA.

Curr Opin Pharmacol. 2002 Aug;2(4):433-9. Review.

PMID:
12127877
31.

Regulatory approvals in a large multinational clinical trial: the ESPRIT experience.

McNay LA, Tavel JA, Oseekey K, McDermott CM, Mollerup D, Bebchuk JD; ESPRIT Group.

Control Clin Trials. 2002 Feb;23(1):59-66.

PMID:
11852166
32.

Ongoing trials of immune-based therapies for HIV infection in adults.

Ross RW, Wright ME, Tavel JA.

Expert Opin Biol Ther. 2001 May;1(3):413-24. Review.

PMID:
11727515
33.

Closeout of four phase II Vanguard trials and patient rollover into a large international phase III HIV clinical endpoint trial.

Tavel JA, Fosdick L; ESPRIT Vanguard Group. ESPRIT Executive Committee.

Control Clin Trials. 2001 Feb;22(1):42-8.

PMID:
11165422
34.

Ongoing trials in HIV protease inhibitors.

Tavel JA.

Expert Opin Investig Drugs. 2000 Apr;9(4):917-28. Review.

PMID:
11060719
35.

A randomized, controlled 24-week study of intermittent subcutaneous interleukin-2 in HIV-1 infected patients in Thailand.

Ruxrungtham K, Suwanagool S, Tavel JA, Chuenyam M, Kroon E, Ubolyam S, Buranapraditkun S, Techasathit W, Li Y, Emery S, Davey RT, Fosdick L, Kunanusont C, Lane HC, Phanuphak P; Vanguard Study Group.

AIDS. 2000 Nov 10;14(16):2509-13.

PMID:
11101062
37.

Treatment and prevention of opportunistic infections in patients with human immunodeficiency virus infection.

Walworth CM, Tavel JA, Kovacs JA.

Adv Intern Med. 1996;41:31-84. Review. No abstract available.

PMID:
8903586

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