AzTrials
AzTrials

HIV InfectionsPhase 3ESPRITNCT00004978

An International Study to Evaluate Recombinant Interleukin-2 in HIV Positive Patients Taking Anti-retroviral Therapy

A Phase 3 study testing Recombinant interleukin-2 (rIL-2) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 248 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
Recombinant interleukin-2 (rIL-2)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,150 participants
Where
248 sitesin 25 countries
Study dates
Mar 2000to Nov 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

248 sites in 25 countries.

248 sites in 25 countries

United States78 sites

  • ARCA, Central Clinc CRS

    Atlanta, Georgia, 30308

  • Emory Univ. Crawford Long Hosp. CRS

    Atlanta, Georgia, 30308

  • NIH Clinical Ctr., NIAID HIV Clinic CRS

    Bethesda, Maryland, 20814-9692

  • National Naval Med. Ctr., Infectious Diseases Special Immunology Clinic CRS

    Bethesda, Maryland, 208995000

  • Cooper Univ. Hosp. CRS

    Camden, New Jersey, 07754

  • Klein & Slotten Medical Associates CRS

    Chicago, Illinois, 60610

  • Jesse Brown VAMC CRS

    Chicago, Illinois, 60612

  • Univ. of Illinois Family Ctr. for Infectious Disease CRS

    Chicago, Illinois, 60612

  • Lakeshore Infectious Disease Associates CRS

    Chicago, Illinois, 60657

  • North Side Family Medicine CRS

    Chicago, Illinois, 60657

  • Northwestern Memorial Physicians Group CRS

    Chicago, Illinois, 60657

  • Atlanta VAMC CRS

    Decatur, Georgia, 30033

  • Denver Infectious Diseases Consultants CRS

    Denver, Colorado, 80204-4507

  • Denver Public Health CRS

    Denver, Colorado

  • Univ. of Colorado Health Science Ctr. CRS

    Denver, Colorado

  • Henry Ford Hosp. CRS

    Detroit, Michigan

  • Wayne State Univ. CRS

    Detroit, Michigan

  • St. John Hosp. & Med. Ctr., Infectious Diseases Dept. CRS

    Grosse Pointe Woods, Michigan, 48236

  • ID Care Inc. - Hillsborough CRS

    Hillsborough, New Jersey, 08844

  • Michael E. DeBakey VAMC CRS

    Houston, Texas, 77030

  • Northwest Clinic CRS

    Houston, Texas, 77030

  • Thomas Street Clinic CRS

    Houston, Texas, 77030

  • Univ. Clinical Research Ctr., Memorial Hermann Hosp. CRS

    Houston, Texas, 77030

  • Legacy Community Health Services, Inc., Montrose Clinic, Inc.

    Houston, Texas

  • VA Greater Los Angeles Healthcare System, Infectious Diseases Section CRS

    Los Angeles, California, 90073

  • Hanover Med. Park (Mechanicsville, VA) CRS

    Mechanicsville, Virginia, 23116

  • Miami VAMC CRS

    Miami, Florida, 33125

  • Univ. of Miami, Infectious Diseases Clinical Research Unit CRS

    Miami, Florida, 33136

  • Dr. M. Estes Med. Practice CRS

    Mill Valley, California, 94941-3013

  • Abbott Northwestern Hosp., Clinic 42 CRS

    Minneapolis, Minnesota, 55404

  • Jersey Shore Univ. Med. Ctr. CRS

    Neptune City, New Jersey, 07754

  • Med. Ctr. of Louisiana at New Orleans, HIV Outpatient Clinics CRS

    New Orleans, Louisiana, 70112

  • Tulane University Health Sciences Center, Louisiana Community AIDS Research Program(LaCARP) CRS

    New Orleans, Louisiana, 70112

  • New Orleans VAMC CRS

    New Orleans, Louisiana, 70146

  • St. Vincent Hosp. & Med. Ctr. CRS

    New York, New York, 10011

  • Harlem Hospital Ctr./Columbia University CRS (Gordin CTU)

    New York, New York, 10037

  • New Jersey Community Research Initiative, Jeffrey Bomser Clinic CRS

    Newark, New Jersey, 07103

  • Cathedral Healthcare System, St. Michael's Med. Ctr. CRS

    Newark, New Jersey

  • Dr. Robert Scott Med. Practice CRS

    Oakland, California, 94609

  • East Bay AIDS Ctr. CRS

    Oakland, California, 94705

  • St. Joseph's Hosp. & Med. Ctr. of New Jersey CRS

    Paterson, New Jersey

  • Raritan Bay Med. Ctr., Perth Amboy Division CRS

    Perth Amboy, New Jersey, 08861

  • Temple Univ. School of Medicine CRS

    Philadelphia, Pennsylvania, 19140

  • Oregon Health & Sciences Univ. Internal Medicine (L-475) CRS

    Portland, Oregon, 97201

  • Multnomah County Health Dept., HIV Health Services Ctr. CRS

    Portland, Oregon, 97204

  • The Research & Education Group-Portland CRS

    Portland, Oregon, 97209

  • Providence Portland Med. Ctr., Ambulatory Care and Education Ctr. CRS

    Portland, Oregon, 97213

  • Kaiser Immune Deficiency Clinic of Portland CRS

    Portland, Oregon, 97227

  • Legacy Clinic Emanuel CRS

    Portland, Oregon, 97301

  • Naval Med. Ctr. Portsmouth CRS

    Portsmouth, Virginia, 23708

  • ID Care - Randolph CRS

    Randolph Township, New Jersey, 07869

  • CrossOver Health Ctr. CRS

    Richmond, Virginia, 23224

  • South Richmond Health Care Ctr. CRS

    Richmond, Virginia, 23224

  • Hunter Holmes McGuire VAMC CRS

    Richmond, Virginia, 23249

  • Virginia Commonwealth Univ. Medical Ctr. CRS

    Richmond, Virginia

  • Mayo Clinic INSIGHT CRS

    Rochester, Minnesota, 55905

  • William Beaumont Hosp., Infectious Disease Research CRS

    Royal Oak, Michigan, 48073

  • Salem Hosp. CRS

    Salem, Oregon, 97301

  • Kaiser Permanente Lancaster Clinic CRS

    Salem, Oregon, 97305

  • South Texas Veterans Health Care System, Immunosuppression Clinic CRS

    San Antonio, Texas, 78284

  • Dr. Shawn Hassler Med. Practice CRS

    San Francisco, California, 94102

  • Positive Health Program Clinic (San Francisco Gen. Hosp.) CRS

    San Francisco, California, 94110-0242

  • Positive Health Practice West/ Dr. Steve Deeks CRS

    San Francisco, California, 94110

  • Dr. William Owen Med. Practice CRS

    San Francisco, California, 94114-1010

  • Dr. Martin Mass Med. Practice CRS

    San Francisco, California, 94114

  • San Francisco VAMC, Infectious Diseases Clinic CRS

    San Francisco, California, 94121

  • UCSF PHP, Gen. Internal Medicine Practice CRS

    San Francisco, California, 94143

  • Castro-Mission Health Ctr. CRS

    San Francisco, California, 94144

  • Dr. Virginia Cafaro Med. Practice CRS

    San Francisco, California

  • Jacobi Med. Ctr., Ambulatory Care Pavillion CRS

    The Bronx, New York, 10461

  • Bronx VAMC CRS

    The Bronx, New York, 10468

  • Infectious Disease Specialists of N.J., North Jersey Community Research Initiative CRS

    Union, New Jersey, 07083

  • The Early Intervention Program at Kennedy Hosp. CRS

    Voorhees Township, New Jersey, 08043

  • Whitman-Walker Clinic CRS

    Washington D.C., District of Columbia, 20009

  • George Washington Univ. Med. Ctr. Infectious Diseases - Clinical Trials Unit CRS

    Washington D.C., District of Columbia, 20037

  • Walter Reed Army Med. Ctr., Infectious Disease Clinic CRS

    Washington D.C., District of Columbia, 20307

  • Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS

    Washington D.C., District of Columbia, 20422

  • Dr. Timothy A. Price Med. Practice CRS

    Washington D.C., District of Columbia

Other trials in United States

Australia23 sites

  • Royal Adelaide Hosp. CRS

    Adelaide, South Australia, 5000

  • The Care & Prevention Programme CRS

    Adelaide, South Australia, 5000

  • Queensland Health - AIDS Med. Unit CRS

    Brisbane, Queensland

  • Burwood Road Gen. Practice CRS

    Burwood, New South Wales, 2134

  • Cairns Base Hosp., Sexual Health Services CRS

    Cairns, Queensland, 4870

  • Interchange General Practice CRS

    Canberra, Australian Capital Territory, 2601

  • Carlton Clinic CRS

    Carlton, Victoria

  • St. Vincent's Hospital CRS

    Darlinghurst, New South Wales, 2010

  • Taylor Square Private Clinic CRS

    Darlinghurst, New South Wales, 2010

  • Holdsworth House Gen. Practice CRS

    Darlinghurst, New South Wales

  • Gladstone Road Medical Ctr. CRS

    Highgate Hill, Queensland, 4101

  • The Alfred Hosp., Clinical Research - Infectious Diseases Unit CRS

    Melbourne, Victoria, 3004

  • Prahran Market Clinic CRS

    Melbourne, Victoria

  • Gold Coast Sexual Health Clinic CRS

    Miami, Queensland

  • Nambour Gen. Hosp. CRS

    Nambour, Queensland, 4560

  • John Hunter Hosp., Immunology & Infectious Diseases Unit CRS

    Newcastle, New South Wales, 2305

  • Northcote Clinic CRS

    Northcote, Victoria, 3070

  • Royal Melbourne Hosp., Victorian Infectious Diseases Service CRS

    Parkville, Victoria, 3052

  • Royal Perth Hospital CRS

    Perth, Western Australia

  • The Ctr. Clinic INSIGHT CRS

    St Kilda, Victoria

  • 407 Doctors CRS

    Surry Hills, New South Wales, 2010

  • Albion Street Ctr. CRS

    Surry Hills, New South Wales

  • Canberra Hosp., Canberra Sexual Health Clinic CRS

    Woden, Australian Capital Territory, 2606

Other trials in Australia

France22 sites

  • CHRU d'Angers, Service de Maladies Infectieuses CRS

    Angers, 49033

  • Hopital Saint-Jacques, Service des Maladies Infectieuses et Tropicales CRS

    Besançon, 25030

  • Hopital Avicenne, Service de Medecine B CRS

    Bobigny, 93009

  • Centre Hospitalier de la Region Annecienne, Service des Maladie Infectieuses CRS

    Cedex, Pringy

  • Hopital Antoine Beclere Service d'Immunologie Clinique CRS

    Clamart, 92141

  • Hopital Louis Mourier, Service de Medecine Interne CRS

    Colombes, 92701

  • Hopital Henri Mondor, Immunopathologie Clinique CRS

    Créteil, 94010

  • Hopital Raymond Poincare - Vidal 2, Service des Maladies Infectieuses et Tropicales CRS

    Garches, 92380

  • Hopital de Bicetre, Service de Medecine Interne CRS

    Le Kremlin-Bicêtre, 94275

  • Hopital Sainte Marguerite, CISIH Hopital de Jour CRS

    Marseille, 13009

  • Hopital de la Conception, Service des Maladies Infectieuses CRS

    Marseille, 13385

  • Hopital Gui de Chauliac, Service des Maladies Infectieuses et Tropicales CRS

    Montpellier, 34295

  • Hopital de l'Archet 1, Service de Medecine Interne 2 Hematologie Clinique CRS

    Nice, 06202

  • Hopital Saint-Antoine, Service de Maladies Infectieuses CRS

    Paris, 75012

  • Hopital de La Salpetriere, Service de Medecine Interne CRS

    Paris, 75651

  • Hopital Cochin, Service de Medecine Interne 2 CRS

    Paris, 75674

  • Hopital Necker, Service des Maladies Infectieuses CRS

    Paris, 75743

  • Hopital Europeen Georges Pompidou, Service d'Immunologie Clinique CRS

    Paris, 75908

  • Hopital Tenon, Service de Maladies Infectieuses et Tropicales CRS

    Paris, 75970

  • C.H.U. Bichat - Claude Bernard Service des Maladies Infectieuses et Tropicales CRS

    Paris

  • CHRU de Strasbourg (France) CRS

    Strasbourg, 67091

  • Hopital Foch, Service de Medecine Interne CRS

    Suresenes, 92151

Other trials in France

United Kingdom20 sites

  • Royal Victoria Hosp. Dept. of Genitourinary Medicine CRS

    Belfast, Northern Ireland

  • Heartlands Hosp. Dept. of Infection & Tropical Disease Outpatients CRS

    Birmingham, B9 5ST

  • Western Gen. Hosp., Regional Infectious Diseases Unit CRS

    Edinburgh, Scotland

  • Brighton & Sussex Univ. Hosp. NHS Trust, HIV Research Office CRS

    Elm Grove, Brighton, BN2 1ES

  • Royal Devon & Exeter NHS Foundation Trust, Heavitree Hosp., Dept. of GU Medicine CRS

    Exeter, EX1 2ED

  • Gartnaval Gen. Hosp., Brownlee Ctr. CRS

    Glasgow, Scotland

  • Churchill Hosp. John Warin Ward CRS

    Headington, Oxford, OX3 9DU

  • Leicester Royal Infirmary, Dept. of Infection & Tropical Medicine CRS

    Leicester, LE1 5WW

  • Royal London Hosp., Ambrose King Ctr. CRS

    London, E1 1BB

  • St. Thomas' Hosp., Dept. of GU Medicine CRS

    London, SE1 7EH

  • St. George's Hosp. Clinical Infection UnitCRS

    London, SW17 0RE

  • Chelsea & Westminster Hosp., St. Stephens Ctr. CRS

    London

  • King's College Hosp., Caldecot Ctr. Dept. of Sexual Health CRS

    London

  • Royal Free Hosp., Dept. of Infection & Immunity, Ian Charleson Day Ctr. CRS

    London

  • St. Bartholomew's Hosp., Infection & Immunity Clinical Group CRS

    London

  • St. Mary's Hosp. of London, Imperial College School of Medicine CRS

    London

  • Univ. College London Med. School, Ctr. for Sexual Health & HIV Research CRS

    London

  • Newcastle Gen. Hosp., Dept of Infection & Tropical Medicine CRS

    Newcastle upon Tyne, NE4 6BE

  • Edith Cavell Hosp. Dept. of Sexual Health, Clinic E CRS

    Peterborough

  • Royal Hallamshire Hosp., Dept. of GU Medicine Communicable Diseases Unit CRS

    Sheffield, S10 2JF

Other trials in United Kingdom

Spain17 sites

  • Hosp. Juan Canalejo, Dept. of Internal Medicine CRS

    A Coruña

  • Hosp. Santa Creu i Sant Pau, Servicio de Medicina Interna CRS

    Barcelona, E-08025

  • Hosp. Clinico de Barcelona CRS

    Barcelona, E-08036

  • Hosp. del Mar, Internal Medicine-Infectious Diseases CRS

    Barcelona

  • Hosp. Universitari Germans Trias i Pujol, HIV Unit and Retrovirology Lab. CRS

    Barcelona

  • Hosp. Donostia CRS

    Donostia / San Sebastian, Guipuzcoa, E-20011

  • Hosp. Universitario Gregorio Maranion, Microbiology & Infectious Diseases Unit CRS

    Madrid, E-28007

  • Centro de Investigacion Carlos III, Infectious Diseases Dept. CRS

    Madrid, E-28029

  • Hosp. Severo Ochoa, Internal Medicine and Infectious Diseases CRS

    Madrid, E-28911

  • Hosp. 12 de Octubre, Pabellon de Medicina Communitaria CRS

    Madrid

  • Hosp. Clinico San Carlos CRS

    Madrid

  • Hosp. la Princesa, Internal Medicine and Infectious Diseases Service CRS

    Madrid

  • Hosp. Ramon y Cajal (Madrid) CRS

    Madrid

  • Hosp. Universitario La Paz CRS

    Madrid

  • Hosp. Universitario Principe de Asturias CRS

    Madrid

  • Hosp. Universitario Morales Meseguer CRS

    Murcia

  • Hosp. Virgen del Rocio, Infectious Diseases Service CRS

    Seville, E-41013

Other trials in Spain

Canada15 sites

  • Univ. of Alberta Hosp., Clinical Research Office CRS

    Edmonton, Alberta

  • CHUS - Hopital Fleurimont, Centre de Recherche Clinique CRS

    Fleurimont, Quebec, J1H 5N4

  • The HAVEN Program, Sudbury Regional Hosp., Laurentian Site CRS

    Greater Sudbury, Ontario, P3E 5J1

  • Q.E. II Health Sciences Ctr., Captial District Authority, Victoria Gen. Hosp. CRS

    Halifax, Nova Scotia

  • McMaster Univ. Med. Ctr. Hamiton Health Sciences, SIS Clinic CRS

    Hamilton, Ontario

  • St. Joseph's Health Ctr. of London, HIV Care Programme CRS

    London, Ontario, N5Y 3H6

  • Hopital Maisonneuve-Rosemont, Dept. de Microbiologie CRS

    Montreal, Quebec, H1T 2M4

  • CHUM - Campus Notre-Dame CRS

    Montreal, Quebec, H2L 4M1

  • Royal Victoria Hosp., Montreal Chest Institute CRS

    Montreal, Quebec

  • Ottawa Hosp., Gen. Campus CRS

    Ottawa, Ontario, K1H 8L6

  • Centre Hospitalier Universitaire de Quebec - CHUL, Centre de Recherche en Indectiologie CRS

    Sainte-Foy, Quebec

  • Royal Univ. Hosp. CRS

    Saskatoon, Saskatchewan, S7N 0W8

  • Toronto Gen. Hosp. Infectious Diseases CRS

    Toronto, Ontario

  • Cool Aid Community Health Ctr. CRS

    Victoria, British Columbia

  • Windsor Regional Hosp., HIV Care Program CRS

    Windsor, Ontario

Other trials in Canada

Argentina13 sites

  • Hosp. de Clinicas Jose de San Martin, Div. Infectologia CRS

    Ciudad de Buenos Aires, Buenos Aires, 1020

  • Hosp. Italiano de Buenos Aires, Infectious Diseases Section CRS

    Ciudad de Buenos Aires, Buenos Aires, 1199

  • Hosp. Gen. de Agudos JM Ramos Mejia, Servicio de Inmunocomprometidos CRS

    Ciudad de Buenos Aires, Buenos Aires, 1221

  • Hospital de Infecciosas F.J. Muniz CRS

    Ciudad de Buenos Aires, Buenos Aires, 1282

  • Funcei Crs

    Ciudad de Buenos Aires, Buenos Aires, 1425

  • Hosp. Gen. de Agudos Juan A. Fernandez CRS

    Ciudad de Buenos Aires, Buenos Aires, 1425

  • Hosp. Gen. de Agudos 'Teodoro Alvarez' CRS

    Ciudad de Buenos Aires, Buenos Aires

  • Hosp. Rawson CRS

    Córdoba, 5000

  • Hospital Nacional Professor Alejandro Posadas CRS

    El Palomar, Buenos Aires, 1706

  • Hosp. Interzonal de Agudos San Juan de Dios CRS

    La Plata, 1900

  • Hospital Interzonal de Agudos Oscar Alende, Sala de Infectologia CRS

    Mar del Plata, Buenos Aires, 7600

  • Hosp. Central, Immunology Dept. CRS

    Mendoza, 5500

  • Caici Crs

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

Germany10 sites

  • Univ. Hosp. Charite, Dept of Infectious Diseases CRS

    Berlin, 13353

  • Ruhr-Univ., Interdiszipl. Immunolog. Ambulanz CRS

    Bochum

  • Medizinische Universitaetsklinik - Bonn, Immunologische Ambulanz CRS

    Bonn, 53105

  • Klinik I fur Innere Medizin der Universitat zu Koln, Studienburo fur Infektiologie u. HIV CRS

    Cologne

  • Ctr. for HIV & Hepatogastroenterology, HIV Specialised Practice (Private Practice) CRS

    Düsseldorf, 40237

  • Johann Wolfgang Goethe Univ. Hosp., Infektionsambulanz CRS

    Frankfurt, 60590

  • IPM Study Ctr. (Hamburg) CRS

    Hamburg

  • Univ. Hosp. Heidelberg, Dept. of Dermatology CRS

    Heidelberg, 69115

  • Klinikum Innenstadt, Infektionsambulanz und Tagesklinik CRS

    München

  • Univ. of Wuerzburg, Medizinische Poliklinik, Schwerpunkt Hepatologie/Infektiologie CRS

    Würzburg

Other trials in Germany

Italy8 sites

  • Civili di Brescia, 1st Division of Infectious Diseases CRS

    Brescia, 25123

  • Civili di Brescia, Dept of Infectious & Tropical Disease, Hosp.Spedali Civili of Brescia CRS

    Brescia, 25123

  • Ospedale S. Maria Annunziata, U.O. Malattie Infettive CRS

    Florence, 50011

  • Ospedale San Raffaele, Centro San Luigi - Divisione Malattie Infettive CRS

    Milan

  • Univ. of Milan, Ospedale Luigi Sacco, Institute of Infectious and Tropical Diseases CRS

    Milan

  • Universita degli Studi di Modena e Reggio Emilia, Clinica delle Malattie Infettive e Tropicali CRS

    Modena

  • San Matteo Hospital - University of Pavia, Division of Infectious and Tropical Diseases CRS

    Pavia, 27100

  • Universita La Sapienza, Clinica Universita La Sapienza CRS

    Roma, 00185

Other trials in Italy

Netherlands6 sites

  • OLVG -- locatie Prinsengracht, Dept. of Internal Medicine II CRS

    Amsterdam, 1017 JZ

  • Academisch Medisch Centrum CRS

    Amsterdam, 1150 AZ

  • Stichting Medisch Centrum Jan van Goyen, Dept. of Internal Medicine CRS

    Amsterdam

  • Groningen Univ. Hosp., Department of Internal Medicine CRS

    Groningen, 9713 GZ

  • Kennemer Gasthuis, Lokatie EG CRS

    Haarlem

  • St. Elisabeth Ziekenhuis CRS

    Tilburg

Other trials in Netherlands

Denmark5 sites

  • Aalborg Hosp., Dept. of Infectious Diseases CRS

    Aalborg

  • Skejby Sygehus, Department of Infectious Diseases Q (ambulatoriet) CRS

    Aarhus, DK-8200

  • Rigshospitalet, Department of Infectious Diseases, M5112 CRS

    Copenhagen

  • Hvidovre Univ. Hosp., Dept. of Infectious Diseases CRS

    Hvidovre

  • Odense Univ. Hosp., Med. Dept. C CRS

    Odense

Other trials in Denmark

Thailand5 sites

  • Siriraj Hosp., Mahidol Univ. INSIGHT CRS

    Bangkok, Ratchathewi, 10700

  • Chulalongkorn Univ. Hosp., HIV-NAT Research Collaboration CRS

    Bangkok, Ratchathewi

  • Chiang Rai Regional Hosp. INSIGHT CRS

    Chiangrai

  • Chonburi Regional Hosp., Dept. of Internal Medicine CRS

    Chon Buri

  • Khon Kaen Univ., Srinagarind Hosp., Div. of Infectious Diseases & Tropical Medicine, Dept. of Medici

    Khon Kaen, 40002

Other trials in Thailand

Poland4 sites

  • Szpital Specjalistyczny, Osrodek Diagnostyki i Terapii AIDS CRS

    Chorzów, 41-500

  • Pomeranian Academy of Medicine (PAM), Dept. of Infectious Diseases and Hepatology CRS

    Szczecin, 71-455

  • Wojewodzki Szpital Zakazny CRS

    Warsaw, 01-201

  • Wroclaw Univ., School of Med., Dept. of Infectious Diseases, Liver Diseases and AIDS CRS

    Wroclaw, 51-171

Other trials in Poland

Brazil3 sites

  • Instituto de Infectologia Emilio Ribas CRS

    São Paulo, 01246-900

  • Universidade Federal de Sao Paulo,IDIPA-Instituto Paulista de Doencas Infecciosas e Parasitarias CRS

    São Paulo, 04040-002

  • Centro de Referencia e Treinamento em DST/AIDS - Sao Paulo CRS

    Vila Mariana, São Paulo, 04121-000

Other trials in Brazil

Israel3 sites

  • Rambam Med. Ctr., Immunology, Allergy & AIDS Institute, B. Rappaport Faculty of Medicine, Technion

    Haifa, 31096

  • Kaplan Med. Ctr., Ben Ari Institute of Clinical Immunology CRS

    Rehovot

  • Tel Aviv Sourasky Med. Ctr., Clinical Immunology Unit and AIDS Ctr. CRS

    Tel Aviv, 64239

Other trials in Israel

Japan3 sites

  • Osaka National Hosp. AIDS Ctr., Clinical Research Institute CRS

    Osaka

  • International Med. Ctr. of Japan CRS

    Tokyo

  • Univ. of Tokyo, Research Hosp. of the Institute of Medical Science CRS

    Tokyo

Other trials in Japan

Portugal3 sites

  • Hospital de Cascais, HDDI, Departamento Medicina Interna CRS

    Cascais, 2775

  • Hosp. de Egas Moniz, Servicio de Infecciologia e Medicina Tropical CRS

    Lisbon, 1349-019

  • Hosp. de Santa Maria, Servico de Doencas Infecciosas CRS

    Lisbon

Other trials in Portugal

Austria2 sites

  • Univ. of Vienna Med. School, Div. of Allergy, Immunology & Infectious Diseases - Sued B CRS

    Vienna, A-1090

  • SMZ Baumgartner Hoehe, Immunambulanz Pavillion Wienerwald Parterre CRS

    Vienna, A-1140

Other trials in Austria

Sweden2 sites

  • Karolinska Univ. Hosp. Huddinge, Dept. of Infectious Diseases CRS

    Stockholm, SE-141 86

  • Venhalsan, Soder Hosp., Dept. of Infectious Diseases, Karolinska Univ. Hosp. CRS

    Stockholm

Other trials in Sweden

Belgium1 site

  • Ctr. Hospitalier Universitaire, St Pierre, Div. of Infectious Diseases (PL5) CRS

    Brussels

Other trials in Belgium

Ireland1 site

  • St. James' Hosp., Guide Clinic CRS

    Dublin

Other trials in Ireland

Morocco1 site

  • Univ. Hosp. Ctr. of the Med. School of Casablanca, Infectious Diseases Unit CRS

    Casablanca

Other trials in Morocco

Norway1 site

  • Ulleval Hosp., Dept. of Infectious Diseases CRS

    Oslo

Other trials in Norway

Singapore1 site

  • Tan Tock Seng Hosp., Infectious Diseases Research Ctr. CRS

    Singapore, 308433

Other trials in Singapore

Switzerland1 site

  • Regional Hosp. of Lugano (Sede Civico), Ospedale Civico di Lugano, Infectious Diseases Unit CRS

    Lugano, Canton Ticino, CH-6903

Other trials in Switzerland

About this study

Official title: 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

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.

Read the detailed description

Much progress has been made in implementing potent antiretroviral therapy that is able to maximally suppress viral replication. However, these drug combinations do not result in viral eradication and, for many patients, virologic and immunologic control cannot be maintained. Even among patients with apparent virologic control, a "ceiling effect" seems to exist with failure of CD4 cell counts to rise on average more than 100 to 150 cells/mm^3, at least during the first 2 years of therapy. The incomplete recovery of immune function after initiation of therapy remains an obstacle in the management of HIV. Preservation of immune function by direct expansion of CD4 lymphocytes with rIL-2 could represent a significant additional treatment strategy. It also has been speculated recently that rIL-2 in combination with potent antiretroviral therapy may be a useful approach for purging HIV from the latently infected CD4 cells. It is hoped that intervention with rIL-2 therapy in combination with antiretroviral therapy at an early stage of HIV infection can prevent CD4 T-cell depletion and result in fewer AIDS-defining illnesses than with antiretroviral therapy alone.

Patients are randomized to receive subcutaneous (SC) rIL-2 therapy or no rIL-2 therapy. All patients must be taking a regimen of combination antiretroviral treatment, with the choice of therapy at the discretion of the treating clinician. Antiretroviral medications are not provided by this study. Recombinant IL-2 is given SC for 5 consecutive days every 8 weeks for at least 3 cycles unless toxicities or other contraindications develop. After the first three cycles, additional cycles are given at the discretion of each patient's physician, with a general goal of maintaining the patient's CD4 cell count at twice the baseline level or at 1,000 cells/mm^3 or above for as long as possible. Patients in the no rIL-2 group receive no injections. Patients in both treatment groups are seen every 4 months for follow-up data collection to monitor viral load and CD4 cell counts. All patients are followed for a minimum of 4 years. During the trial, patients in the no SC rIL-2 group are not given rIL-2 at any point. However, at the end of the study, if rIL-2 is found to be effective in reducing the rate of disease progression [AS PER AMENDMENT 12/15/00: (new and recurrent events)], including death, all patients are offered rIL-2.

Conditions
HIV Infections
Being tested
Recombinant interleukin-2 (rIL-2)
Keywords
Recombinant Proteins, Injections, Subcutaneous, HIV-1, Interleukin-2, Drug Therapy, Combination, CD4 Lymphocyte Count, Disease Progression, Follow-Up Studies, Anti-HIV Agents
Medical subject headings
HIV Infections, Disease Progression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recombinant interleukin-2 (rIL-2)Drug

    Also called Proleukin, IL-2, Aldesleukin

    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.

Study groups in NCT00004978
Study groupRoleWhat they receive
rIL-2ExperimentalRecombinant interleukin-2 (rIL-2) therapy used with combination anti-HIV medication of choice.
Receives: Drug: Recombinant interleukin-2 (rIL-2)
No rIL-2No interventionControl arm uses anti-HIV medication of choice without rIL-2.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: from randomization through study end - median of 7.6 years follow-up

Secondary outcomes (9)

  1. New or Recurrent Serious HIV Disease Progression Event Including Death

    Patients with at least one: progressive multifocal leukoencephalopathy, lymphoma, visceral Kaposi's sarcoma, AIDS dementia complex, toxoplasmosis, histoplasmosis, cryptococcosis, Mycobacterium avium complex, wasting syndrome, and cytomegalovirus disease.

    Measured: from randomization through study end - median of 7.6 years follow-up

  2. Number of Participants Who Died From Any Cause

    Measured: from randomization through study end - median of 7.6 years follow-up

  3. Participants With a New Disease Progression Event or Death

    Includes first new episode of: CDC Category C 1993 AIDS-defining events plus 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

    Measured: from randomization through 15 November 2008 - median of 7.6 years follow-up

  4. Absolute CD4 Cell Counts Averaged Throughout Followup

    Average of all available CD4+ cell counts measured at follow-up visits

    Measured: from randomization through study end - median of 7.6 years follow-up

  5. Plasma HIV RNA Levels

    log10 HIV-RNA averaged throughout follow-up

    Measured: From randomization through study end - median of 7.6 years follow-up

  6. Number of Participants With Changes in Anti-retroviral Treatment (ART)

    Number of participants who changed ART at least once during the study period.

    Measured: From randomization through study end - median of 7.6 years follow-up

  7. Grade 4 Signs and Symptoms

    Participants with at least one grade 4 sign or symptom (except those limited to a laboratory measurement), other than AIDS-defining conditions. Events were graded according to a standardized toxicity table. Events not specifically contained in the toxicity table were considered Grade 4 if they resulted in extreme limitation in activity or required significant medical intervention/therapy, hospitalization or hospice care. Grade 4 events by type are given under the adverse events section.

    Measured: From randomization through study end - median of 7.6 years follow-up

  8. Pattern of Use of Prophylaxis for Opportunistic Infections

    Number of participants using pneumocystis pneumonia (PCP) prophylaxis at the last attended followup visit.

    Measured: last followup visit - median of 7.6 years follow-up

  9. Hepatic, Metabolic, and Cardiac Conditions

    Number of participants experiencing a "serious non-AIDS" event defined as first serious cardiovascular, renal, or hepatic event, or non-AIDS malignancy.

    Measured: From randomization through study end - median of 7.6 years follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)
  2. Study startMar 2000
  3. Primary completionNov 2008
  4. Study completionNov 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4,150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00004978
Sponsor's protocol ID
ESPRIT 001
Other IDs
5U01AI046957, 00 I-0071, 3U01AI046957-05S2, 3U01AI046957-05S3, 10118
Acronym
ESPRIT
Status last verified
Oct 2012
First submitted
10 Mar 2000
Last updated
5 Nov 2021
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 10371503

  • Connors 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.

    PubMed 9142122

  • Emery 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.

    PubMed 11943448

  • 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. 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.

    PubMed 15206062

  • INSIGHT-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.

    PubMed 19828532

  • Larson 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.

    PubMed 26908541

  • Nordell 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.

    PubMed 24870935

  • Mocroft 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.

    PubMed 22911697

  • Pett 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.

    PubMed 20812949

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Recombinant interleukin-2 (rIL-2) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 248 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 248 sites in United States, Australia, France, United Kingdom, Spain and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

New or Recurrent HIV Disease Progression Event Including Death (time frame: from randomization through study end - median of 7.6 years follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00004978, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.

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