An International Study to Evaluate Recombinant Interleukin-2 in HIV Positive Patients Taking Anti-retroviral Therapy
ESPRIT
A Randomized, Open-Label, Phase III, International Study of Subcutaneous Recombinant IL-2 in Patients With HIV-1 Infection and CD4+ Cell Counts 300/mm^3 or Greater: Evaluation of Subcutaneous Proleukin in a Randomized International Trial
6 other identifiers
interventional
4,150
24 countries
225
Brief Summary
The purpose of this study is to see if it is effective to give HIV positive patients recombinant interleukin-2 (rIL-2) in addition to anti-HIV therapy. Patients will be followed over a minimum of 4 years to study the long-term effects of rIL-2 on their HIV disease progression. Anti-HIV therapy has been very successful in treating HIV positive patients and in keeping viral load (level of HIV in the blood) low. However, anti-HIV drugs cannot completely rid the body of the virus, and the immune system is never completely restored in HIV positive patients. Doctors hope that giving patients recombinant interleukin-2 (rIL-2) in addition to their anti-HIV therapy will help improve their immune systems and keep them healthier over a longer period of time. rIL-2 is a hormone naturally produced by the body during an immune response to a microbial infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hiv-infections
Started Mar 2000
Longer than P75 for phase_3 hiv-infections
225 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2000
CompletedFirst Submitted
Initial submission to the registry
March 10, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedResults Posted
Study results publicly available
April 25, 2011
CompletedNovember 5, 2021
October 1, 2012
8.7 years
March 10, 2000
January 20, 2011
November 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
New or Recurrent HIV Disease Progression Event Including Death
Participants who die or experience at least one: any CDC Category C 1993 AIDS-defining events or one of the following: invasive aspergillosis, bartonellosis, Chagas disease, Herpes zoster, visceral Leishmaniasis, Hodgkin's lymphoma, non-Hodgkin's lymphoma (all cell types), microsporidiosis, nocardiosis, disseminated Penicillium marneffii, extrapulmonary Pneumocystis carinii, and Rhodococcus equi disease
from randomization through study end - median of 7.6 years follow-up
Secondary Outcomes (9)
New or Recurrent Serious HIV Disease Progression Event Including Death
from randomization through study end - median of 7.6 years follow-up
Number of Participants Who Died From Any Cause
from randomization through study end - median of 7.6 years follow-up
Participants With a New Disease Progression Event or Death
from randomization through 15 November 2008 - median of 7.6 years follow-up
Absolute CD4 Cell Counts Averaged Throughout Followup
from randomization through study end - median of 7.6 years follow-up
Plasma HIV RNA Levels
From randomization through study end - median of 7.6 years follow-up
- +4 more secondary outcomes
Study Arms (2)
rIL-2
EXPERIMENTALRecombinant interleukin-2 (rIL-2) therapy used with combination anti-HIV medication of choice.
No rIL-2
NO INTERVENTIONControl arm uses anti-HIV medication of choice without rIL-2.
Interventions
Recombinant interleukin-2 at a dose of 7.5 MIU given twice daily subcutaneously for 5 consecutive days every 8 weeks for at least 3 cycles.
Eligibility Criteria
You may qualify if:
- HIV positive
- Have a CD4 cell count of 300 cells/mm3 or more within 45 days of study entry
- Are on combination anti-HIV therapy or are beginning anti-HIV therapy at the time of study entry
- Are at least 18 years old
You may not qualify if:
- Have received IL-2 before
- Have cancer requiring chemotherapy
- Have evidence of active clinical disease within the past year for any AIDS-defining illness or certain other conditions such as herpes zoster or Chagas disease. (This study has been changed. Previously, patients were ineligible if they had a history of any AIDS-defining illness or certain other conditions.)
- Have used certain medications, such as corticosteroids or drugs affecting the immune system, in the 45 days before study entry
- Have a nervous system disorder requiring antiseizure medication
- Have an autoimmune or inflammatory disease such as inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), psoriasis, optic neuritis, or any autoimmune/inflammatory diseases with potentially life-threatening complications
- Are pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (248)
VA Greater Los Angeles Healthcare System, Infectious Diseases Section CRS
Los Angeles, California, 90073, United States
Dr. M. Estes Med. Practice CRS
Mill Valley, California, 94941-3013, United States
Dr. Robert Scott Med. Practice CRS
Oakland, California, 94609, United States
East Bay AIDS Ctr. CRS
Oakland, California, 94705, United States
Dr. Shawn Hassler Med. Practice CRS
San Francisco, California, 94102, United States
Positive Health Program Clinic (San Francisco Gen. Hosp.) CRS
San Francisco, California, 94110-0242, United States
Positive Health Practice West/ Dr. Steve Deeks CRS
San Francisco, California, 94110, United States
Dr. William Owen Med. Practice CRS
San Francisco, California, 94114-1010, United States
Dr. Martin Mass Med. Practice CRS
San Francisco, California, 94114, United States
San Francisco VAMC, Infectious Diseases Clinic CRS
San Francisco, California, 94121, United States
UCSF PHP, Gen. Internal Medicine Practice CRS
San Francisco, California, 94143, United States
Castro-Mission Health Ctr. CRS
San Francisco, California, 94144, United States
Dr. Virginia Cafaro Med. Practice CRS
San Francisco, California, United States
Denver Infectious Diseases Consultants CRS
Denver, Colorado, 80204-4507, United States
Denver Public Health CRS
Denver, Colorado, United States
Univ. of Colorado Health Science Ctr. CRS
Denver, Colorado, United States
Whitman-Walker Clinic CRS
Washington D.C., District of Columbia, 20009, United States
George Washington Univ. Med. Ctr. Infectious Diseases - Clinical Trials Unit CRS
Washington D.C., District of Columbia, 20037, United States
Walter Reed Army Med. Ctr., Infectious Disease Clinic CRS
Washington D.C., District of Columbia, 20307, United States
Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS
Washington D.C., District of Columbia, 20422, United States
Dr. Timothy A. Price Med. Practice CRS
Washington D.C., District of Columbia, United States
Miami VAMC CRS
Miami, Florida, 33125, United States
Univ. of Miami, Infectious Diseases Clinical Research Unit CRS
Miami, Florida, 33136, United States
ARCA, Central Clinc CRS
Atlanta, Georgia, 30308, United States
Emory Univ. Crawford Long Hosp. CRS
Atlanta, Georgia, 30308, United States
Atlanta VAMC CRS
Decatur, Georgia, 30033, United States
Klein & Slotten Medical Associates CRS
Chicago, Illinois, 60610, United States
Jesse Brown VAMC CRS
Chicago, Illinois, 60612, United States
Univ. of Illinois Family Ctr. for Infectious Disease CRS
Chicago, Illinois, 60612, United States
Lakeshore Infectious Disease Associates CRS
Chicago, Illinois, 60657, United States
North Side Family Medicine CRS
Chicago, Illinois, 60657, United States
Northwestern Memorial Physicians Group CRS
Chicago, Illinois, 60657, United States
Med. Ctr. of Louisiana at New Orleans, HIV Outpatient Clinics CRS
New Orleans, Louisiana, 70112, United States
Tulane University Health Sciences Center, Louisiana Community AIDS Research Program(LaCARP) CRS
New Orleans, Louisiana, 70112, United States
New Orleans VAMC CRS
New Orleans, Louisiana, 70146, United States
NIH Clinical Ctr., NIAID HIV Clinic CRS
Bethesda, Maryland, 20814-9692, United States
National Naval Med. Ctr., Infectious Diseases Special Immunology Clinic CRS
Bethesda, Maryland, 208995000, United States
Henry Ford Hosp. CRS
Detroit, Michigan, United States
Wayne State Univ. CRS
Detroit, Michigan, United States
St. John Hosp. & Med. Ctr., Infectious Diseases Dept. CRS
Grosse Pointe Woods, Michigan, 48236, United States
William Beaumont Hosp., Infectious Disease Research CRS
Royal Oak, Michigan, 48073, United States
Abbott Northwestern Hosp., Clinic 42 CRS
Minneapolis, Minnesota, 55404, United States
Mayo Clinic INSIGHT CRS
Rochester, Minnesota, 55905, United States
Cooper Univ. Hosp. CRS
Camden, New Jersey, 07754, United States
ID Care Inc. - Hillsborough CRS
Hillsborough, New Jersey, 08844, United States
Jersey Shore Univ. Med. Ctr. CRS
Neptune City, New Jersey, 07754, United States
New Jersey Community Research Initiative, Jeffrey Bomser Clinic CRS
Newark, New Jersey, 07103, United States
Cathedral Healthcare System, St. Michael's Med. Ctr. CRS
Newark, New Jersey, United States
St. Joseph's Hosp. & Med. Ctr. of New Jersey CRS
Paterson, New Jersey, United States
Raritan Bay Med. Ctr., Perth Amboy Division CRS
Perth Amboy, New Jersey, 08861, United States
ID Care - Randolph CRS
Randolph Township, New Jersey, 07869, United States
Infectious Disease Specialists of N.J., North Jersey Community Research Initiative CRS
Union, New Jersey, 07083, United States
The Early Intervention Program at Kennedy Hosp. CRS
Voorhees Township, New Jersey, 08043, United States
St. Vincent Hosp. & Med. Ctr. CRS
New York, New York, 10011, United States
Harlem Hospital Ctr./Columbia University CRS (Gordin CTU)
New York, New York, 10037, United States
Jacobi Med. Ctr., Ambulatory Care Pavillion CRS
The Bronx, New York, 10461, United States
Bronx VAMC CRS
The Bronx, New York, 10468, United States
Oregon Health & Sciences Univ. Internal Medicine (L-475) CRS
Portland, Oregon, 97201, United States
Multnomah County Health Dept., HIV Health Services Ctr. CRS
Portland, Oregon, 97204, United States
The Research & Education Group-Portland CRS
Portland, Oregon, 97209, United States
Providence Portland Med. Ctr., Ambulatory Care and Education Ctr. CRS
Portland, Oregon, 97213, United States
Kaiser Immune Deficiency Clinic of Portland CRS
Portland, Oregon, 97227, United States
Legacy Clinic Emanuel CRS
Portland, Oregon, 97301, United States
Salem Hosp. CRS
Salem, Oregon, 97301, United States
Kaiser Permanente Lancaster Clinic CRS
Salem, Oregon, 97305, United States
Temple Univ. School of Medicine CRS
Philadelphia, Pennsylvania, 19140, United States
Michael E. DeBakey VAMC CRS
Houston, Texas, 77030, United States
Northwest Clinic CRS
Houston, Texas, 77030, United States
Thomas Street Clinic CRS
Houston, Texas, 77030, United States
Univ. Clinical Research Ctr., Memorial Hermann Hosp. CRS
Houston, Texas, 77030, United States
Legacy Community Health Services, Inc., Montrose Clinic, Inc.
Houston, Texas, United States
South Texas Veterans Health Care System, Immunosuppression Clinic CRS
San Antonio, Texas, 78284, United States
Hanover Med. Park (Mechanicsville, VA) CRS
Mechanicsville, Virginia, 23116, United States
Naval Med. Ctr. Portsmouth CRS
Portsmouth, Virginia, 23708, United States
CrossOver Health Ctr. CRS
Richmond, Virginia, 23224, United States
South Richmond Health Care Ctr. CRS
Richmond, Virginia, 23224, United States
Hunter Holmes McGuire VAMC CRS
Richmond, Virginia, 23249, United States
Virginia Commonwealth Univ. Medical Ctr. CRS
Richmond, Virginia, United States
Hosp. de Clinicas Jose de San Martin, Div. Infectologia CRS
Ciudad de Buenos Aires, Buenos Aires, 1020, Argentina
Hosp. Italiano de Buenos Aires, Infectious Diseases Section CRS
Ciudad de Buenos Aires, Buenos Aires, 1199, Argentina
Hosp. Gen. de Agudos JM Ramos Mejia, Servicio de Inmunocomprometidos CRS
Ciudad de Buenos Aires, Buenos Aires, 1221, Argentina
Hospital de Infecciosas F.J. Muniz CRS
Ciudad de Buenos Aires, Buenos Aires, 1282, Argentina
Funcei Crs
Ciudad de Buenos Aires, Buenos Aires, 1425, Argentina
Hosp. Gen. de Agudos Juan A. Fernandez CRS
Ciudad de Buenos Aires, Buenos Aires, 1425, Argentina
Hosp. Gen. de Agudos 'Teodoro Alvarez' CRS
Ciudad de Buenos Aires, Buenos Aires, Argentina
Hospital Nacional Professor Alejandro Posadas CRS
El Palomar, Buenos Aires, 1706, Argentina
Hospital Interzonal de Agudos Oscar Alende, Sala de Infectologia CRS
Mar del Plata, Buenos Aires, 7600, Argentina
Caici Crs
Rosario, Santa Fe Province, 2000, Argentina
Hosp. Rawson CRS
Córdoba, 5000, Argentina
Hosp. Interzonal de Agudos San Juan de Dios CRS
La Plata, 1900, Argentina
Hosp. Central, Immunology Dept. CRS
Mendoza, 5500, Argentina
Interchange General Practice CRS
Canberra, Australian Capital Territory, 2601, Australia
Canberra Hosp., Canberra Sexual Health Clinic CRS
Woden, Australian Capital Territory, 2606, Australia
Burwood Road Gen. Practice CRS
Burwood, New South Wales, 2134, Australia
St. Vincent's Hospital CRS
Darlinghurst, New South Wales, 2010, Australia
Taylor Square Private Clinic CRS
Darlinghurst, New South Wales, 2010, Australia
Holdsworth House Gen. Practice CRS
Darlinghurst, New South Wales, Australia
John Hunter Hosp., Immunology & Infectious Diseases Unit CRS
Newcastle, New South Wales, 2305, Australia
407 Doctors CRS
Surry Hills, New South Wales, 2010, Australia
Albion Street Ctr. CRS
Surry Hills, New South Wales, Australia
Queensland Health - AIDS Med. Unit CRS
Brisbane, Queensland, Australia
Cairns Base Hosp., Sexual Health Services CRS
Cairns, Queensland, 4870, Australia
Gladstone Road Medical Ctr. CRS
Highgate Hill, Queensland, 4101, Australia
Nambour Gen. Hosp. CRS
Nambour, Queensland, 4560, Australia
Royal Adelaide Hosp. CRS
Adelaide, South Australia, 5000, Australia
The Care & Prevention Programme CRS
Adelaide, South Australia, 5000, Australia
Carlton Clinic CRS
Carlton, Victoria, Australia
The Alfred Hosp., Clinical Research - Infectious Diseases Unit CRS
Melbourne, Victoria, 3004, Australia
Prahran Market Clinic CRS
Melbourne, Victoria, Australia
Northcote Clinic CRS
Northcote, Victoria, 3070, Australia
Royal Melbourne Hosp., Victorian Infectious Diseases Service CRS
Parkville, Victoria, 3052, Australia
The Ctr. Clinic INSIGHT CRS
St Kilda, Victoria, Australia
Royal Perth Hospital CRS
Perth, Western Australia, Australia
Gold Coast Sexual Health Clinic CRS
Miami, Queensland, Australia
Univ. of Vienna Med. School, Div. of Allergy, Immunology & Infectious Diseases - Sued B CRS
Vienna, A-1090, Austria
SMZ Baumgartner Hoehe, Immunambulanz Pavillion Wienerwald Parterre CRS
Vienna, A-1140, Austria
Ctr. Hospitalier Universitaire, St Pierre, Div. of Infectious Diseases (PL5) CRS
Brussels, Belgium
Centro de Referencia e Treinamento em DST/AIDS - Sao Paulo CRS
Vila Mariana, São Paulo, 04121-000, Brazil
Instituto de Infectologia Emilio Ribas CRS
São Paulo, 01246-900, Brazil
Universidade Federal de Sao Paulo,IDIPA-Instituto Paulista de Doencas Infecciosas e Parasitarias CRS
São Paulo, 04040-002, Brazil
Univ. of Alberta Hosp., Clinical Research Office CRS
Edmonton, Alberta, Canada
Cool Aid Community Health Ctr. CRS
Victoria, British Columbia, Canada
Q.E. II Health Sciences Ctr., Captial District Authority, Victoria Gen. Hosp. CRS
Halifax, Nova Scotia, Canada
The HAVEN Program, Sudbury Regional Hosp., Laurentian Site CRS
Greater Sudbury, Ontario, P3E 5J1, Canada
McMaster Univ. Med. Ctr. Hamiton Health Sciences, SIS Clinic CRS
Hamilton, Ontario, Canada
St. Joseph's Health Ctr. of London, HIV Care Programme CRS
London, Ontario, N5Y 3H6, Canada
Ottawa Hosp., Gen. Campus CRS
Ottawa, Ontario, K1H 8L6, Canada
Toronto Gen. Hosp. Infectious Diseases CRS
Toronto, Ontario, Canada
Windsor Regional Hosp., HIV Care Program CRS
Windsor, Ontario, Canada
CHUS - Hopital Fleurimont, Centre de Recherche Clinique CRS
Fleurimont, Quebec, J1H 5N4, Canada
Hopital Maisonneuve-Rosemont, Dept. de Microbiologie CRS
Montreal, Quebec, H1T 2M4, Canada
CHUM - Campus Notre-Dame CRS
Montreal, Quebec, H2L 4M1, Canada
Royal Victoria Hosp., Montreal Chest Institute CRS
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec - CHUL, Centre de Recherche en Indectiologie CRS
Sainte-Foy, Quebec, Canada
Royal Univ. Hosp. CRS
Saskatoon, Saskatchewan, S7N 0W8, Canada
Aalborg Hosp., Dept. of Infectious Diseases CRS
Aalborg, Denmark
Skejby Sygehus, Department of Infectious Diseases Q (ambulatoriet) CRS
Aarhus, DK-8200, Denmark
Rigshospitalet, Department of Infectious Diseases, M5112 CRS
Copenhagen, Denmark
Hvidovre Univ. Hosp., Dept. of Infectious Diseases CRS
Hvidovre, Denmark
Odense Univ. Hosp., Med. Dept. C CRS
Odense, Denmark
Centre Hospitalier de la Region Annecienne, Service des Maladie Infectieuses CRS
Cedex, Pringy, France
CHRU d'Angers, Service de Maladies Infectieuses CRS
Angers, 49033, France
Hopital Saint-Jacques, Service des Maladies Infectieuses et Tropicales CRS
Besançon, 25030, France
Hopital Avicenne, Service de Medecine B CRS
Bobigny, 93009, France
Hopital Antoine Beclere Service d'Immunologie Clinique CRS
Clamart, 92141, France
Hopital Louis Mourier, Service de Medecine Interne CRS
Colombes, 92701, France
Hopital Henri Mondor, Immunopathologie Clinique CRS
Créteil, 94010, France
Hopital Raymond Poincare - Vidal 2, Service des Maladies Infectieuses et Tropicales CRS
Garches, 92380, France
Hopital de Bicetre, Service de Medecine Interne CRS
Le Kremlin-Bicêtre, 94275, France
Hopital Sainte Marguerite, CISIH Hopital de Jour CRS
Marseille, 13009, France
Hopital de la Conception, Service des Maladies Infectieuses CRS
Marseille, 13385, France
Hopital Gui de Chauliac, Service des Maladies Infectieuses et Tropicales CRS
Montpellier, 34295, France
Hopital de l'Archet 1, Service de Medecine Interne 2 Hematologie Clinique CRS
Nice, 06202, France
Hopital Saint-Antoine, Service de Maladies Infectieuses CRS
Paris, 75012, France
Hopital de La Salpetriere, Service de Medecine Interne CRS
Paris, 75651, France
Hopital Cochin, Service de Medecine Interne 2 CRS
Paris, 75674, France
Hopital Necker, Service des Maladies Infectieuses CRS
Paris, 75743, France
Hopital Europeen Georges Pompidou, Service d'Immunologie Clinique CRS
Paris, 75908, France
Hopital Tenon, Service de Maladies Infectieuses et Tropicales CRS
Paris, 75970, France
C.H.U. Bichat - Claude Bernard Service des Maladies Infectieuses et Tropicales CRS
Paris, France
CHRU de Strasbourg (France) CRS
Strasbourg, 67091, France
Hopital Foch, Service de Medecine Interne CRS
Suresenes, 92151, France
Univ. Hosp. Charite, Dept of Infectious Diseases CRS
Berlin, 13353, Germany
Ruhr-Univ., Interdiszipl. Immunolog. Ambulanz CRS
Bochum, Germany
Medizinische Universitaetsklinik - Bonn, Immunologische Ambulanz CRS
Bonn, 53105, Germany
Klinik I fur Innere Medizin der Universitat zu Koln, Studienburo fur Infektiologie u. HIV CRS
Cologne, Germany
Ctr. for HIV & Hepatogastroenterology, HIV Specialised Practice (Private Practice) CRS
Düsseldorf, 40237, Germany
Johann Wolfgang Goethe Univ. Hosp., Infektionsambulanz CRS
Frankfurt, 60590, Germany
IPM Study Ctr. (Hamburg) CRS
Hamburg, Germany
Univ. Hosp. Heidelberg, Dept. of Dermatology CRS
Heidelberg, 69115, Germany
Klinikum Innenstadt, Infektionsambulanz und Tagesklinik CRS
München, Germany
Univ. of Wuerzburg, Medizinische Poliklinik, Schwerpunkt Hepatologie/Infektiologie CRS
Würzburg, Germany
St. James' Hosp., Guide Clinic CRS
Dublin, Ireland
Rambam Med. Ctr., Immunology, Allergy & AIDS Institute, B. Rappaport Faculty of Medicine, Technion
Haifa, 31096, Israel
Kaplan Med. Ctr., Ben Ari Institute of Clinical Immunology CRS
Rehovot, Israel
Tel Aviv Sourasky Med. Ctr., Clinical Immunology Unit and AIDS Ctr. CRS
Tel Aviv, 64239, Israel
Civili di Brescia, 1st Division of Infectious Diseases CRS
Brescia, 25123, Italy
Civili di Brescia, Dept of Infectious & Tropical Disease, Hosp.Spedali Civili of Brescia CRS
Brescia, 25123, Italy
Ospedale S. Maria Annunziata, U.O. Malattie Infettive CRS
Florence, 50011, Italy
Ospedale San Raffaele, Centro San Luigi - Divisione Malattie Infettive CRS
Milan, Italy
Univ. of Milan, Ospedale Luigi Sacco, Institute of Infectious and Tropical Diseases CRS
Milan, Italy
Universita degli Studi di Modena e Reggio Emilia, Clinica delle Malattie Infettive e Tropicali CRS
Modena, Italy
San Matteo Hospital - University of Pavia, Division of Infectious and Tropical Diseases CRS
Pavia, 27100, Italy
Universita La Sapienza, Clinica Universita La Sapienza CRS
Roma, 00185, Italy
Osaka National Hosp. AIDS Ctr., Clinical Research Institute CRS
Osaka, Japan
International Med. Ctr. of Japan CRS
Tokyo, Japan
Univ. of Tokyo, Research Hosp. of the Institute of Medical Science CRS
Tokyo, Japan
Univ. Hosp. Ctr. of the Med. School of Casablanca, Infectious Diseases Unit CRS
Casablanca, Morocco
OLVG -- locatie Prinsengracht, Dept. of Internal Medicine II CRS
Amsterdam, 1017 JZ, Netherlands
Academisch Medisch Centrum CRS
Amsterdam, 1150 AZ, Netherlands
Stichting Medisch Centrum Jan van Goyen, Dept. of Internal Medicine CRS
Amsterdam, Netherlands
Groningen Univ. Hosp., Department of Internal Medicine CRS
Groningen, 9713 GZ, Netherlands
Kennemer Gasthuis, Lokatie EG CRS
Haarlem, Netherlands
St. Elisabeth Ziekenhuis CRS
Tilburg, Netherlands
Ulleval Hosp., Dept. of Infectious Diseases CRS
Oslo, Norway
Szpital Specjalistyczny, Osrodek Diagnostyki i Terapii AIDS CRS
Chorzów, 41-500, Poland
Pomeranian Academy of Medicine (PAM), Dept. of Infectious Diseases and Hepatology CRS
Szczecin, 71-455, Poland
Wojewodzki Szpital Zakazny CRS
Warsaw, 01-201, Poland
Wroclaw Univ., School of Med., Dept. of Infectious Diseases, Liver Diseases and AIDS CRS
Wroclaw, 51-171, Poland
Hospital de Cascais, HDDI, Departamento Medicina Interna CRS
Cascais, 2775, Portugal
Hosp. de Egas Moniz, Servicio de Infecciologia e Medicina Tropical CRS
Lisbon, 1349-019, Portugal
Hosp. de Santa Maria, Servico de Doencas Infecciosas CRS
Lisbon, Portugal
Tan Tock Seng Hosp., Infectious Diseases Research Ctr. CRS
Singapore, 308433, Singapore
Hosp. Donostia CRS
Donostia / San Sebastian, Guipuzcoa, E-20011, Spain
Hosp. Juan Canalejo, Dept. of Internal Medicine CRS
A Coruña, Spain
Hosp. Santa Creu i Sant Pau, Servicio de Medicina Interna CRS
Barcelona, E-08025, Spain
Hosp. Clinico de Barcelona CRS
Barcelona, E-08036, Spain
Hosp. del Mar, Internal Medicine-Infectious Diseases CRS
Barcelona, Spain
Hosp. Universitari Germans Trias i Pujol, HIV Unit and Retrovirology Lab. CRS
Barcelona, Spain
Hosp. Universitario Gregorio Maranion, Microbiology & Infectious Diseases Unit CRS
Madrid, E-28007, Spain
Centro de Investigacion Carlos III, Infectious Diseases Dept. CRS
Madrid, E-28029, Spain
Hosp. Severo Ochoa, Internal Medicine and Infectious Diseases CRS
Madrid, E-28911, Spain
Hosp. 12 de Octubre, Pabellon de Medicina Communitaria CRS
Madrid, Spain
Hosp. Clinico San Carlos CRS
Madrid, Spain
Hosp. la Princesa, Internal Medicine and Infectious Diseases Service CRS
Madrid, Spain
Hosp. Ramon y Cajal (Madrid) CRS
Madrid, Spain
Hosp. Universitario La Paz CRS
Madrid, Spain
Hosp. Universitario Principe de Asturias CRS
Madrid, Spain
Hosp. Universitario Morales Meseguer CRS
Murcia, Spain
Hosp. Virgen del Rocio, Infectious Diseases Service CRS
Seville, E-41013, Spain
Karolinska Univ. Hosp. Huddinge, Dept. of Infectious Diseases CRS
Stockholm, SE-141 86, Sweden
Venhalsan, Soder Hosp., Dept. of Infectious Diseases, Karolinska Univ. Hosp. CRS
Stockholm, Sweden
Regional Hosp. of Lugano (Sede Civico), Ospedale Civico di Lugano, Infectious Diseases Unit CRS
Lugano, Canton Ticino, CH-6903, Switzerland
Siriraj Hosp., Mahidol Univ. INSIGHT CRS
Bangkok, Ratchathewi, 10700, Thailand
Chulalongkorn Univ. Hosp., HIV-NAT Research Collaboration CRS
Bangkok, Ratchathewi, Thailand
Chiang Rai Regional Hosp. INSIGHT CRS
Chiangrai, Thailand
Chonburi Regional Hosp., Dept. of Internal Medicine CRS
Chon Buri, Thailand
Khon Kaen Univ., Srinagarind Hosp., Div. of Infectious Diseases & Tropical Medicine, Dept. of Medici
Khon Kaen, 40002, Thailand
Brighton & Sussex Univ. Hosp. NHS Trust, HIV Research Office CRS
Elm Grove, Brighton, BN2 1ES, United Kingdom
Royal Victoria Hosp. Dept. of Genitourinary Medicine CRS
Belfast, Northern Ireland, United Kingdom
Churchill Hosp. John Warin Ward CRS
Headington, Oxford, OX3 9DU, United Kingdom
Western Gen. Hosp., Regional Infectious Diseases Unit CRS
Edinburgh, Scotland, United Kingdom
Gartnaval Gen. Hosp., Brownlee Ctr. CRS
Glasgow, Scotland, United Kingdom
Heartlands Hosp. Dept. of Infection & Tropical Disease Outpatients CRS
Birmingham, B9 5ST, United Kingdom
Royal Devon & Exeter NHS Foundation Trust, Heavitree Hosp., Dept. of GU Medicine CRS
Exeter, EX1 2ED, United Kingdom
Leicester Royal Infirmary, Dept. of Infection & Tropical Medicine CRS
Leicester, LE1 5WW, United Kingdom
Royal London Hosp., Ambrose King Ctr. CRS
London, E1 1BB, United Kingdom
St. Thomas' Hosp., Dept. of GU Medicine CRS
London, SE1 7EH, United Kingdom
St. George's Hosp. Clinical Infection UnitCRS
London, SW17 0RE, United Kingdom
Chelsea & Westminster Hosp., St. Stephens Ctr. CRS
London, United Kingdom
King's College Hosp., Caldecot Ctr. Dept. of Sexual Health CRS
London, United Kingdom
Royal Free Hosp., Dept. of Infection & Immunity, Ian Charleson Day Ctr. CRS
London, United Kingdom
St. Bartholomew's Hosp., Infection & Immunity Clinical Group CRS
London, United Kingdom
St. Mary's Hosp. of London, Imperial College School of Medicine CRS
London, United Kingdom
Univ. College London Med. School, Ctr. for Sexual Health & HIV Research CRS
London, United Kingdom
Newcastle Gen. Hosp., Dept of Infection & Tropical Medicine CRS
Newcastle upon Tyne, NE4 6BE, United Kingdom
Edith Cavell Hosp. Dept. of Sexual Health, Clinic E CRS
Peterborough, United Kingdom
Royal Hallamshire Hosp., Dept. of GU Medicine Communicable Diseases Unit CRS
Sheffield, S10 2JF, United Kingdom
Related Publications (9)
Chun TW, Engel D, Mizell SB, Hallahan CW, Fischette M, Park S, Davey RT Jr, Dybul M, Kovacs JA, Metcalf JA, Mican JM, Berrey MM, Corey L, Lane HC, Fauci AS. Effect of interleukin-2 on the pool of latently infected, resting CD4+ T cells in HIV-1-infected patients receiving highly active anti-retroviral therapy. Nat Med. 1999 Jun;5(6):651-5. doi: 10.1038/9498.
PMID: 10371503BACKGROUNDConnors M, Kovacs JA, Krevat S, Gea-Banacloche JC, Sneller MC, Flanigan M, Metcalf JA, Walker RE, Falloon J, Baseler M, Feuerstein I, Masur H, Lane HC. HIV infection induces changes in CD4+ T-cell phenotype and depletions within the CD4+ T-cell repertoire that are not immediately restored by antiviral or immune-based therapies. Nat Med. 1997 May;3(5):533-40. doi: 10.1038/nm0597-533.
PMID: 9142122BACKGROUNDEmery S, Abrams DI, Cooper DA, Darbyshire JH, Lane HC, Lundgren JD, Neaton JD; ESPRIT Study Group. The evaluation of subcutaneous proleukin (interleukin-2) in a randomized international trial: rationale, design, and methods of ESPRIT. Control Clin Trials. 2002 Apr;23(2):198-220. doi: 10.1016/s0197-2456(01)00179-9.
PMID: 11943448BACKGROUNDArduino 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. CD4 cell response to 3 doses of subcutaneous interleukin 2: meta-analysis of 3 Vanguard studies. Clin Infect Dis. 2004 Jul 1;39(1):115-22. doi: 10.1086/421775. Epub 2004 Jun 14.
PMID: 15206062RESULTINSIGHT-ESPRIT Study Group; SILCAAT Scientific Committee; Abrams D, Levy Y, Losso MH, Babiker A, Collins G, Cooper DA, Darbyshire J, Emery S, Fox L, Gordin F, Lane HC, Lundgren JD, Mitsuyasu R, Neaton JD, Phillips A, Routy JP, Tambussi G, Wentworth D. Interleukin-2 therapy in patients with HIV infection. N Engl J Med. 2009 Oct 15;361(16):1548-59. doi: 10.1056/NEJMoa0903175.
PMID: 19828532RESULTLarson GS, Carey C, Grarup J, Hudson F, Sachi K, Vjecha MJ, Gordin F; INSIGHT Group. Lessons learned: Infrastructure development and financial management for large, publicly funded, international trials. Clin Trials. 2016 Apr;13(2):127-36. doi: 10.1177/1740774515625974. Epub 2016 Feb 8.
PMID: 26908541DERIVEDNordell AD, McKenna M, Borges AH, Duprez D, Neuhaus J, Neaton JD; INSIGHT SMART, ESPRIT Study Groups; SILCAAT Scientific Committee. Severity of cardiovascular disease outcomes among patients with HIV is related to markers of inflammation and coagulation. J Am Heart Assoc. 2014 May 28;3(3):e000844. doi: 10.1161/JAHA.114.000844.
PMID: 24870935DERIVEDMocroft A, Neuhaus J, Peters L, Ryom L, Bickel M, Grint D, Koirala J, Szymczak A, Lundgren J, Ross MJ, Wyatt CM; INSIGHT SMART Study Group; ESPRIT Study Group. Hepatitis B and C co-infection are independent predictors of progressive kidney disease in HIV-positive, antiretroviral-treated adults. PLoS One. 2012;7(7):e40245. doi: 10.1371/journal.pone.0040245. Epub 2012 Jul 20.
PMID: 22911697DERIVEDPett SL, Carey C, Lin E, Wentworth D, Lazovski J, Miro JM, Gordin F, Angus B, Rodriguez-Barradas M, Rubio R, Tambussi G, Cooper DA, Emery S; INSIGHT-ESPRIT Study Group. Predictors of bacterial pneumonia in Evaluation of Subcutaneous Interleukin-2 in a Randomized International Trial (ESPRIT). HIV Med. 2011 Apr;12(4):219-27. doi: 10.1111/j.1468-1293.2010.00875.x. Epub 2010 Aug 31.
PMID: 20812949DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- James Neaton, PhD
- Organization
- Division of Biostatistics, University of Minnesota
Study Officials
- STUDY CHAIR
Donald Abrams, MD
University of California, San Francisco
- STUDY CHAIR
Marcelo Losso, MD
Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2000
First Posted
August 31, 2001
Study Start
March 1, 2000
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
November 5, 2021
Results First Posted
April 25, 2011
Record last verified: 2012-10