Evaluation of subcutaneous proleukin (interleukin-2) in a randomized international trial (ESPRIT): Geographical and gender differences in the baseline characteristics of participants

HIV Clinical Trials

Volumn 7, Issue 2, 2006, Pages 70-85

  Pett, Sarah L ^a   Wand, H ^a   Law, M G ^a   Arduino, R ^b   Lopez, J C ^c   Knysz, B ^d   Pereira, L C ^e   Pollack, S ^f   Reiss, P ^g   Tambussi, G ^h   Abrams, Donald I ^k   Cooper, David A ^k   Darbyshire, Janet H ^k   Duncan, William R ^k   Emery, Sean ^k   Clifford Lane, H ^k   Lehrman, Sandra ^k   Lundgren, Jens D ^k   Neaton, James D ^k   Aguilar, Liliana ⁱ   Angel, Eleonora Betina ⁱ   Aquilia, Silvia ⁱ   Belloso, Waldo ⁱ   Benetucci, Jorge ⁱ   Bittar, Victor ⁱ   Cahn, Pedro ⁱ   Casiro, Arnaldo ⁱ   Contarelli, Jorge ⁱ   Corral, Jorge ⁱ   Daciuk, Lucia ⁱ   David, Daniel ⁱ   Ines, Ferrari ⁱ   Fridman, Diego ⁱ   Galache, Viviana ⁱ   Guaragna, Graciela ⁱ   Ivalo, Silvina ⁱ   Laplume, Hector ⁱ   Lasala, Maria B ⁱ   Lattes, Roberta ⁱ   Lasovsky, Jaime ⁱ   Lopardo, Gustavo ⁱ   Losso, Marcelo ⁱ   Lourtau, Leonardo ⁱ   Lupo, Sergio ⁱ   Maranzana, Aldo ⁱ   Marson, Cristina ⁱ   Massera, Lucila ⁱ   del Lujan Sanchez, Marisa ⁱ   Somenzini, Carla ⁱ   Tocci, Mariel ⁱ   Algar, Sally ^j   Anderson, Jonathan ^j   Austin, David ^j   Baker, David ^j   Blavius, Kathy ^j   Bloch, Mark ^j   Boyle, Michael ^j   Bradford, David ^j   Carrall, Leah ^j   Carr, Andrew ^j   Chuah, John ^j   Curry, Michael ^j   D'Arcy Evans, Clive ^j   Dobson, Pauline ^j   Doong, Nicholas ^j   Ferguson, Wendy ^j   Finlayson, Robert ^j   French, Martyn ^j   Gold, Julian ^j   Habel, Philip ^j   Hoy, Jennifer ^j   Hudson, Jeff ^j   James, Robyn ^j   Jeganathan, Sarangapany ^j   Leung, Jenny ^j   Lowe, Kaye ^j   MacRae, Karen ^j   Mallal, Simon ^j   McMurchie, Marilyn ^j   Medland, Nicholas ^j   Mijch, Anne ^j   Miller, Samantha ^j   Murray, Jo ^j   Orth, David ^j   Patching, Julie ^j   Primrose, Ruth ^j   Quan, Dick ^j   Rawlinson, Michael ^j   Ree, Hugo ^j   Richardson, Robyn ^j   Rogers, Gary ^j   Roney, Janine ^j   Roth, Norman ^j   Shaw, David ^j   Soo, Tuck Meng ^j   Sowden, David ^j   Street, Alison ^j   Street, Alan ^j   Vale, Robyn ^j   more..

^a UNIVERSITY OF NEW SOUTH WALES   (Australia)

^b UNIVERSITY OF TEXAS MEDICAL SCHOOL   (United States)

^c HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑÓN   (Spain)

^d WROCLAW MEDICAL UNIVERSITY   (Poland)

^e INSTITUTO DE INFECTOLOGIA EMÍLIO RIBAS   (Brazil)

^f RAMBAM MEDICAL CENTER   (Israel)

^g ACADEMIC MEDICAL CENTER   (Netherlands)

^h SAN RAFFAELE HOSPITAL   (Italy)

ⁱ Argentina National Coordinating Center   (Argentina)

^j Australia National Trial Coordinating Center   (Australia)

^k NONE

more..

Author keywords

AIDS defining illness; ESPRIT; HIV; Proression of disease; Recombinant interleukin 2

Indexed keywords

ANTIHYPERTENSIVE AGENT; ANTILIPEMIC AGENT; ANTIRETROVIRUS AGENT; HEPATITIS B SURFACE ANTIGEN; HEPATITIS B VACCINE; HERPES VACCINE; INSULIN; ORAL ANTIDIABETIC AGENT; PROTEINASE INHIBITOR; RECOMBINANT INTERLEUKIN 2; RITONAVIR; RNA DIRECTED DNA POLYMERASE INHIBITOR; VIRUS RNA;

ADULT; AFRICAN AMERICAN; AIDS RELATED COMPLEX; ANAMNESIS; ARGENTINA; ARTICLE; ASIA; ASIAN; AUSTRALIA; BACTERIAL PNEUMONIA; CANDIDIASIS; CD4 LYMPHOCYTE COUNT; CLINICAL TRIAL; COHORT ANALYSIS; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEATH; DIABETES MELLITUS; DISEASE COURSE; DISEASE DURATION; DISEASE TRANSMISSION; DRUG EFFICACY; DRUG SAFETY; DYSLIPIDEMIA; ETHNOLOGY; EUROPE; FEMALE; GEOGRAPHIC DISTRIBUTION; HEART INFARCTION; HEPATITIS B; HEPATITIS C; HERPES SIMPLEX; HETEROSEXUALITY; HIV ASSOCIATED LIPODYSTROPHY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPERTENSION; INTRAVENOUS DRUG ABUSE; LIPID STORAGE; MAJOR CLINICAL STUDY; MALE; MALE HOMOSEXUAL; METHODOLOGY; NEGRO; NONHUMAN; NORTH AMERICA; OPEN STUDY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEX DIFFERENCE; SIDE EFFECT; SOUTH AMERICA; STROKE; SUPERINFECTION; THAILAND; TIME SERIES ANALYSIS; TREATMENT DURATION; TREATMENT OUTCOME; TUBERCULOSIS; VIRUS LOAD;

ADULT; ANTI-HIV AGENTS; ANTIRETROVIRAL THERAPY, HIGHLY ACTIVE; DATA COLLECTION; ETHNIC GROUPS; FEMALE; HEPATITIS B; HEPATITIS C; HIV INFECTIONS; HIV-1; HUMANS; INJECTIONS, SUBCUTANEOUS; INTERLEUKIN-2; MALE; RANDOMIZED CONTROLLED TRIALS; RECOMBINANT PROTEINS; SEXUAL BEHAVIOR; TREATMENT OUTCOME; WOMEN'S HEALTH; WORLD HEALTH;

EID: 33746131906     PISSN: 15284336     EISSN: None     Source Type: Journal    
DOI: 10.1310/4733-ACQF-F3P4-2QAC     Document Type: Article

References (30)

1. Finzi D, Hermankova M, Pierson T, et al. Identification of a reservoir for HIV-1 in patients on highly active antiretroviral therapy. Science. 1997;278:1295-1300.
2. Wong JK, Hezareh M, Gunthard HF, et al. Recovery of replication competent HIV despite prolonged suppression of plasma viraemia. Science. 1997;278:1291-1295.
3. Bangsberg DR, Moss AR, Deeks SG. Paradoxes of adherence and drug resistance to HIV antiretroviral therapy. J Antimicrob Chemother. 2004;53(5):696-699. Epub 2004 Mar 24.
4. John M, Nolan D, Mallal S. Antiretroviral therapy and the lipodystrophy syndrome. Antiviral Ther. 2001;6:9-20.
5. Friis-Moller N, Sabin CA, Weber R, et al. Combination antiretroviral therapy and the risk of myocardial infarction. N Engl J Med. 2003;349(21):1993-2003.
6. Nelson M, Matthews G, Brook MG, et al. BHIVA guidelines on HIV and chronic hepatitis: co-infection with HIV and hepatitis C virus infection (2005). HIV Med. 2005;6 (Suppl 2):96-106.
7. Yeni PG, Hammer SM, Hirsch MS, et al. Antiretroviral treatment for adult HIV infection. 2004 Recommendations of the International AIDS Society-USA panel. JAMA. 2004;292(2):251-265.
8. Davey RT, Chaitt RT, Piscitelli SC, et al. Subcutaneous administration of interleukin-2 in human immunodeficiency virus type-1 infected persons. J Infect Dis. 1997;175:781-789.
9. Carr A, Emery S, Lloyd A, et al. Outpatient continuous intravenous interleukin-2 or subcutaneous, polyethylene glycol modified interleukin-2 in human immunodeficiency virus-infected patients: a randomized, controlled, multicenter study. J Infect Dis. 1998;178:992-999.
10. Levy Y, Capitant C, Houhou S, et al. Comparison of subcutaneous and intravenous interleukin-2 in asymptomatic HIV-1 infection: a randomised controlled trial. ANRS 048 study group. Lancet. 1999;353:1923-1929.
11. Davey RT, Chaitt D, Albert JM, et al. A randomized trial of high- versus low-dose subcutaneous interleukin-2 outpatient therapy for early human immunodeficiency virus type-1 infection. J Infect Dis. 1999;179:849-858.
12. Miller KD, Spooner K, Herpin BR, et al. Immunotherapy of HIV-infected patients with intermittent interleukin-2: effects of cycle frequency and cycle duration on degree of CD4+ T-lymphocyte expansion. Clin Immunol. 2001;99(1):30-42.
13. Davey RT, Murphy RL, Graziano FM, et al. Immunologic and virologic effects of subcutaneous interleukin-2 in combination with antiretroviral therapy: a randomised controlled trial. JAMA. 2000;284:183-189.
14. 3: CPCRA 059. J AIDS. 2002;29:221-231.
15. Arduino RC, Nannini EC, Rodriguez-Barradas, et al. CD4 cell response to 3 doses of subcutaneous interleukin 2: meta-analysis of 3 Vanguard studies. Clin Infect Dis. 2004;39(1):115-122. Epub 2004 Jun 14.
16. Natarajan V, Lempicki RA, Sereti I, et al. Increased peripheral expansion of naïve CD4+ T cells in vivo after IL-2 treatment of patients with HIV infection. PNAS. 2002;99(16):10712-10717.
17. Sereti I, Martinez-Wilson H, Metcalf JA, et al. Long-term effects of intermittent interleukin-2 therapy in patients with HIV infection: characterization of a novel subset of CD4+/CD25+ T-cells. Blood. 2002;100(6):2159-2167.
18. Kovacs JA, Lempicki RA, Sidorov IA, et al. Induction of prolonged survival of CD4+ T-lymphocytes by intermittent IL-2 therapy in HIV-infected patients. J Clin Invest. 2005;115:2139-2148.
19. Emery S, Capra WB, Cooper DA, et al. Pooled analysis of 3 randomized, controlled trials of interleukin-2 therapy in adult human immunodeficiency virus type 1 disease. J Infect Dis. 2000;182:428-434.
20. Emery S, Abrams DI, Cooper DA, et al. The evaluation of subcutaneous Proleukin (interleukin-2) in a randomised international trial: rational, design and methods of ESPRIT. Control Clin Trials. 2002;23(2):198-220.
21. www.silcaat.org
22. Tavel JA, Fosdick L, et al. Close out of four phase II vanguard trials and patient roll-over into a large international phase III HIV clinical endpoint trial. Cont Clin Trials. 2001;22:42-48.
23. Centers for Disease Control and Prevention. 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. MMWR. 1992;41:1-20.
24. Neaton JD, Wentworth DN, Rhame F, et al. Methods of studying interventions: considerations in choice of a clinical endpoint for AIDS clinical trials. Stat Med. 1994;13:2107-2125.
25. Gandhi MN, Ameli P, Bacchetti GB, et al. Eligibility criteria for HIV clinical trials and generalisability of results: the gap between published reports and study protocols. AIDS. In press.
26. www.fda.gov
27. Egger, M, May M, Chene G, et al. Prognosis of HIV-1 infected patients starting highly active antiretroviral therapy: a collaborative analysis of prospective studies. Lancet. 2002;360:119-129.
28. Mocroft A, Lederberger B, Katlama C, et al. Decline in the AIDS and death rates in the EuroSIDA study: an observational study. Lancet. 2003;362:22-29.
29. Carpenter CC, Cooper DA, Fischl MA, et al. Antiretroviral therapy in adults: updated recommendations of the International AIDS Society-USA Panel. JAMA. 2000;283(3):381-390.
30. Masur H, Kaplan JE, Holmes KK, U.S. Public Health Service, Infectious Diseases Society of America. Guidelines for preventing opportunistic infections among HIV-infected persons - 2002. Recommendations of the U.S. Public Health Service and the Infectious Diseases Society of America. Ann Intern Med. 2002;137(5 Pt 2):435-478.