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Publications 2000-2005

2005

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. The quality of informed consent in a clinical research study in Thailand. IRB:
Ethics & Human Research 2005; 27(1):9-17.

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. Informed consent: practices and views of investigators in a multinational clinical trial. IRB:
Ethics & Human Research 2005; 27(5):13-18.

2004

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. CD4 cell response to 3 doses of subcutaneous interleukin-2: Meta-analysis of 3 vanguard studies.
Clin Infect Dis 2004; 39(1):115-122.

2003

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

2002

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. 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.
JAIDS 2002; 29:221-231.

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

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

2001

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

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

2000

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. 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.
J Infect Dis 2000; 181:1614-1621.

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. A randomized, controlled 24-week study of intermittent subcutaneous interleukin-2 in HIV-1 infected patients in Thailand.
AIDS 2000; 14:2509-2513.