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ESPRIT Publications

2016

1 HCV RNA profiles among HIV/HCV coinfected individuals in ESPRIT; spontaneous HCV RNA clearance observed in 9 individuals.  Grint D et al.
 HIV Med

2010
1 Immunodeficiency and the risk of serious clinical endpoints in a well studied cohort of treated HIV-infected patients. A Achhra, J Amin, MG Law, S Emery, J Gerstoft, FM Gordin, MJ Vjecha, JD Neaton, DA Cooper for INSIGHT ESPRIT & SILCAAT study groups.
AIDS 2010; 24(12):1877-1886. abstract

2009
1 Benefits and burdens of participation in a longitudinal clinical trial. J Lazovski, M Losso, B Krohmal, EJ Emanuel, C Grady, D Wendler for the ESPRIT Study/Group.
J Empir Res Hum Res Ethics 2009; 4(3):89-97. abstract

2 Interleukin-2 Therapy in Patients with HIV Infection. The INSIGHT-ESPRIT Study Group and SILCAAT Scientific Committee.
N Engl J Med 2009; 361:1548-1559. abstract

2008
1 Determination of the underlying cause of death in three multicenter international HIV clinical trials. AR Lifson and the INSIGHT Cause of Death Writing Group: WH Belloso, C Carey, RT Davey, D Duprez, WM El-Sadr, JM Gatell, DC Gey, JF Hoy, EA Krum, R Nelson, DE Nixon, N Paton, C Pedersen, G Perez, RW Price, RJ Prineas, FS Rhame, J Sampson, J Worley
HIV Clin Trials 2008; 9:177-185. abstract

2 Why patients continue to participate in clinical research. D Wendler, B Krohmal, EJ Emanuel, C Grady for the ESPRIT Group.
Arch Int Med 2008; 168(12):1294-1299. abstract

2007
1 Predictors of CD4 count change over 8 months of follow up in HIV-1-infected patients with a CD4 count ≥ 300 cells/microL who were assigned to 7.5 MIU interleukin-2. ESPRIT Research Group (Fox Z, Antunes F, Davey R, Gazzard B, Klimas N, Labriola A, Losso M, Neaton JD, Phillips AN, Ruxrungtham K, Staszewski S, Weiss L, Lundgren JD).
HIV Med 2007; 8(2):112-123. abstract

2 CD8 apoptosis may be a predictor of T cell number normalization after immune reconstitution in HIV. Lewis DE, Gross KL, Diez MM, Martinez ML, Lukefahr HN, Kozinetz CA, Arduino RC.
J Transl Med 2007; 5(1):9.doi:10.1186/1479-5876-5-9. abstract

2006
1 Reporting and evaluation of HIV-related clinical endpoints in two multicenter international clinical trials. Lifson AR, Rhame FS, Belloso WH, Dragsted UB, El-Sadr WM, Gatell JM, Hoy JF, Krum EA, Nelson R, Pedersen C, Pett SL, Davey RT Jr.
HIV Clin Trials 2006; 7(3):125-141. abstract

2 The feasibility of clinical endpoint trials in HIV infection in the highly active antiretroviral treatment (HAART) era. Mocroft A, Neaton J, Bebchuk J, Staszewski S, Antunes F, Knysz B, Law M, Phillips AN, Lundgren JD for the EuroSIDA and ESPRIT Study Groups.
Clinical Trials 2006; 3:119-132. abstract

3 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 for the ESPRIT Group.
AIDS Research and Human Retroviruses 2006; 22(9):837-841. abstract

4 Evaluation of Subcutaneous Proleukin (interleukin-2) in a Randomized International Trial (ESPRIT): Geographical and gender differences in the baseline characteristics of participants. Pett SL, Wand H, Law MG, Arduino R, Lopez JC, Knysz B, Pereira LC, Pollack S, Reiss P, Tambussi G for the ESPRIT Research Group.
HIV Clin Trials 2006; 7(2):70-85. abstract

5 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; 1(1):e3. abstract

2005
1 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 for the ESPRIT Group.
IRB: Ethics & Human Research 2005; 27(1):9-17. abstract

2 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 for the ESPRIT Group.
IRB: Ethics & Human Research 2005; 27(5):13-18. abstract

2004
1 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 for the ESPRIT Vanguard Group and the ESPRIT Executive Committee.
Clin Infect Dis 2004; 39(1):115-122. abstract

2003
1 Nadir CD4+ T cell count predicts response to subcutaneous recombinant interleukin-2. Markowitz N, Bebchuk JD, Abrams DI and the Terry Beirn Community Programs for Clinical Research on AIDS.
Clin Infect Dis 2003; 37:e115-e120. abstract

2002
1 Randomized, open-label study of the impact of two doses of subcutaneous recombinant interleukin-2 on viral burden in patients with HIV-1 infection and CD4+ cell counts of >300/mm3: CPCRA 059. Abrams DI, Bebchuk JD, Denning ET, Davey RT, Fox L, Lane HC, Sampson J, Verheggen R, Zeh D, Markowitz NP for the Terry Beirn Community Programs for Clinical Research on AIDS.
JAIDS 2002; 29:221-231. abstract

2 The Evaluation of Subcutaneous Proleukin (R) (interleukin-2) in a Randomized International Trial: Rationale, design, and methods of ESPRIT. Emery S, Abrams DI, Cooper DA, Darbyshire JH, Lane HC, Lundgren JD, Neaton JD, and the ESPRIT Study Group.
Control Clin Trials 2002; 23:198-220. abstract

3 Regulatory approvals in a large multinational clinical trial: the ESPRIT experience. McNay LA, Tavel JA, Oseekey K, McDermott CM, Mollerup D, Bebchuk JD for the ESPRIT Group.
Control Clin Trials 2002; 23:59-66. abstract

2001
1 ESPRIT: A randomised, open-label, international study of subcutaneous recombinant interleukin-2. Aboulhab J, Babiker GA, Hooker MH, Darbyshire J and the ESPRIT Study Group.
HIV & AIDS Current Trends 2001; 7(1):8-12. 

2 Closeout of four phase II vanguard trials and patient rollover into a large international phase III HIV clinical endpoint trial. Tavel JA, Fosdick L for the ESPRIT Vanguard Group and the ESPRIT Executive Committee.
Control Clin Trials 2001; 22:42-48. abstract

2000
1 A randomized, controlled, phase II trial comparing escalating doses of subcutaneous interleukin-2 plus antiretrovirals versus antiretrovirals alone in human immunodeficiency virus-infected patients with CD4+ cell counts > 350/mm3. Losso MH, Belloso WH, Emery S, Benetucci JA, Cahn PE, Lasala MC, Lopardo G, Salomon H, Saracco M, Nelson E, Law MG, Davey RT, Allende MC, Lane HC and the Vanguard Study Group.
J Infect Dis 2000; 181:1614-1621. abstract

2 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, Kunanausont C, Lane HC, Phanuphak P and the Vanguard Study Group.
AIDS 2000; 14:2509-2513. abstract


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