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

PHASE3CompletedINTERVENTIONAL
Enrollment

4,150

Participants

Timeline

Start Date

March 31, 2000

Primary Completion Date

November 30, 2008

Study Completion Date

November 30, 2008

Conditions
HIV Infections
Interventions
DRUG

Recombinant interleukin-2 (rIL-2)

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.

Trial Locations (248)

1020

Hosp. de Clinicas Jose de San Martin, Div. Infectologia CRS, Ciudad de Buenos Aires

1199

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

1221

Hosp. Gen. de Agudos JM Ramos Mejia, Servicio de Inmunocomprometidos CRS, Ciudad de Buenos Aires

1282

Hospital de Infecciosas F.J. Muniz CRS, Ciudad de Buenos Aires

1425

Funcei Crs, Ciudad de Buenos Aires

Hosp. Gen. de Agudos Juan A. Fernandez CRS, Ciudad de Buenos Aires

1706

Hospital Nacional Professor Alejandro Posadas CRS, El Palomar

1900

Hosp. Interzonal de Agudos San Juan de Dios CRS, La Plata

2000

Caici Crs, Rosario

2010

St. Vincent's Hospital CRS, Darlinghurst

Taylor Square Private Clinic CRS, Darlinghurst

407 Doctors CRS, Surry Hills

2134

Burwood Road Gen. Practice CRS, Burwood

2305

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

2601

Interchange General Practice CRS, Canberra

2606

Canberra Hosp., Canberra Sexual Health Clinic CRS, Woden

2775

Hospital de Cascais, HDDI, Departamento Medicina Interna CRS, Cascais

3004

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

3052

Royal Melbourne Hosp., Victorian Infectious Diseases Service CRS, Parkville

3070

Northcote Clinic CRS, Northcote

4101

Gladstone Road Medical Ctr. CRS, Highgate Hill

4560

Nambour Gen. Hosp. CRS, Nambour

4870

Cairns Base Hosp., Sexual Health Services CRS, Cairns

5000

Hosp. Rawson CRS, Córdoba

Royal Adelaide Hosp. CRS, Adelaide

The Care & Prevention Programme CRS, Adelaide

5500

Hosp. Central, Immunology Dept. CRS, Mendoza

7600

Hospital Interzonal de Agudos Oscar Alende, Sala de Infectologia CRS, Mar del Plata

10011

St. Vincent Hosp. & Med. Ctr. CRS, New York

10037

Harlem Hospital Ctr./Columbia University CRS (Gordin CTU), New York

10461

Jacobi Med. Ctr., Ambulatory Care Pavillion CRS, The Bronx

10468

Bronx VAMC CRS, The Bronx

10700

Siriraj Hosp., Mahidol Univ. INSIGHT CRS, Bangkok

13009

Hopital Sainte Marguerite, CISIH Hopital de Jour CRS, Marseille

13353

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

13385

Hopital de la Conception, Service des Maladies Infectieuses CRS, Marseille

19140

Temple Univ. School of Medicine CRS, Philadelphia

20009

Whitman-Walker Clinic CRS, Washington D.C.

20037

George Washington Univ. Med. Ctr. Infectious Diseases - Clinical Trials Unit CRS, Washington D.C.

20307

Walter Reed Army Med. Ctr., Infectious Disease Clinic CRS, Washington D.C.

20422

Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS, Washington D.C.

23116

Hanover Med. Park (Mechanicsville, VA) CRS, Mechanicsville

23224

CrossOver Health Ctr. CRS, Richmond

South Richmond Health Care Ctr. CRS, Richmond

23249

Hunter Holmes McGuire VAMC CRS, Richmond

23708

Naval Med. Ctr. Portsmouth CRS, Portsmouth

25030

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

25123

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

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

27100

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

30033

Atlanta VAMC CRS, Decatur

30308

ARCA, Central Clinc CRS, Atlanta

Emory Univ. Crawford Long Hosp. CRS, Atlanta

31096

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

33125

Miami VAMC CRS, Miami

33136

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

34295

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

40002

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

40237

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

48073

William Beaumont Hosp., Infectious Disease Research CRS, Royal Oak

48236

St. John Hosp. & Med. Ctr., Infectious Diseases Dept. CRS, Grosse Pointe Woods

49033

CHRU d'Angers, Service de Maladies Infectieuses CRS, Angers

50011

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

53105

Medizinische Universitaetsklinik - Bonn, Immunologische Ambulanz CRS, Bonn

55404

Abbott Northwestern Hosp., Clinic 42 CRS, Minneapolis

55905

Mayo Clinic INSIGHT CRS, Rochester

60590

Johann Wolfgang Goethe Univ. Hosp., Infektionsambulanz CRS, Frankfurt

60610

Klein & Slotten Medical Associates CRS, Chicago

60612

Jesse Brown VAMC CRS, Chicago

Univ. of Illinois Family Ctr. for Infectious Disease CRS, Chicago

60657

Lakeshore Infectious Disease Associates CRS, Chicago

North Side Family Medicine CRS, Chicago

Northwestern Memorial Physicians Group CRS, Chicago

64239

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

67091

CHRU de Strasbourg (France) CRS, Strasbourg

69115

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

70112

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

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

70146

New Orleans VAMC CRS, New Orleans

75012

Hopital Saint-Antoine, Service de Maladies Infectieuses CRS, Paris

75651

Hopital de La Salpetriere, Service de Medecine Interne CRS, Paris

75674

Hopital Cochin, Service de Medecine Interne 2 CRS, Paris

75743

Hopital Necker, Service des Maladies Infectieuses CRS, Paris

75908

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

75970

Hopital Tenon, Service de Maladies Infectieuses et Tropicales CRS, Paris

77030

Michael E. DeBakey VAMC CRS, Houston

Northwest Clinic CRS, Houston

Thomas Street Clinic CRS, Houston

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

78284

South Texas Veterans Health Care System, Immunosuppression Clinic CRS, San Antonio

90073

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

92141

Hopital Antoine Beclere Service d'Immunologie Clinique CRS, Clamart

92151

Hopital Foch, Service de Medecine Interne CRS, Suresenes

92380

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

92701

Hopital Louis Mourier, Service de Medecine Interne CRS, Colombes

93009

Hopital Avicenne, Service de Medecine B CRS, Bobigny

94010

Hopital Henri Mondor, Immunopathologie Clinique CRS, Créteil

94102

Dr. Shawn Hassler Med. Practice CRS, San Francisco

94110

Positive Health Practice West/ Dr. Steve Deeks CRS, San Francisco

94114

Dr. Martin Mass Med. Practice CRS, San Francisco

94121

San Francisco VAMC, Infectious Diseases Clinic CRS, San Francisco

94143

UCSF PHP, Gen. Internal Medicine Practice CRS, San Francisco

94144

Castro-Mission Health Ctr. CRS, San Francisco

94275

Hopital de Bicetre, Service de Medecine Interne CRS, Le Kremlin-Bicêtre

94609

Dr. Robert Scott Med. Practice CRS, Oakland

94705

East Bay AIDS Ctr. CRS, Oakland

97201

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

97204

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

97209

The Research & Education Group-Portland CRS, Portland

97213

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

97227

Kaiser Immune Deficiency Clinic of Portland CRS, Portland

97301

Legacy Clinic Emanuel CRS, Portland

Salem Hosp. CRS, Salem

97305

Kaiser Permanente Lancaster Clinic CRS, Salem

308433

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

208995000

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

94941-3013

Dr. M. Estes Med. Practice CRS, Mill Valley

94110-0242

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

94114-1010

Dr. William Owen Med. Practice CRS, San Francisco

Unknown

Dr. Virginia Cafaro Med. Practice CRS, San Francisco

Denver Public Health CRS, Denver

Univ. of Colorado Health Science Ctr. CRS, Denver

Dr. Timothy A. Price Med. Practice CRS, Washington D.C.

Henry Ford Hosp. CRS, Detroit

Wayne State Univ. CRS, Detroit

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

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

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

Virginia Commonwealth Univ. Medical Ctr. CRS, Richmond

Hosp. Gen. de Agudos 'Teodoro Alvarez' CRS, Ciudad de Buenos Aires

Holdsworth House Gen. Practice CRS, Darlinghurst

Albion Street Ctr. CRS, Surry Hills

Queensland Health - AIDS Med. Unit CRS, Brisbane

Carlton Clinic CRS, Carlton

Prahran Market Clinic CRS, Melbourne

The Ctr. Clinic INSIGHT CRS, St Kilda

Royal Perth Hospital CRS, Perth

Gold Coast Sexual Health Clinic CRS, Miami, Queensland

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

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

Cool Aid Community Health Ctr. CRS, Victoria

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

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

Toronto Gen. Hosp. Infectious Diseases CRS, Toronto

Windsor Regional Hosp., HIV Care Program CRS, Windsor

Royal Victoria Hosp., Montreal Chest Institute CRS, Montreal

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

Aalborg Hosp., Dept. of Infectious Diseases CRS, Aalborg

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

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

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

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

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

IPM Study Ctr. (Hamburg) CRS, Hamburg

Klinikum Innenstadt, Infektionsambulanz und Tagesklinik CRS, München

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

St. James' Hosp., Guide Clinic CRS, Dublin

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

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

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

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

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

Kennemer Gasthuis, Lokatie EG CRS, Haarlem

St. Elisabeth Ziekenhuis CRS, Tilburg

Ulleval Hosp., Dept. of Infectious Diseases CRS, Oslo

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

Hosp. Juan Canalejo, Dept. of Internal Medicine CRS, A Coruña

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

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

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

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

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

Chiang Rai Regional Hosp. INSIGHT CRS, Chiangrai

Chonburi Regional Hosp., Dept. of Internal Medicine CRS, Chon Buri

Royal Victoria Hosp. Dept. of Genitourinary Medicine CRS, Belfast

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

Gartnaval Gen. Hosp., Brownlee Ctr. CRS, Glasgow

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

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

80204-4507

Denver Infectious Diseases Consultants CRS, Denver

20814-9692

NIH Clinical Ctr., NIAID HIV Clinic CRS, Bethesda

07754

Cooper Univ. Hosp. CRS, Camden

Jersey Shore Univ. Med. Ctr. CRS, Neptune City

08844

ID Care Inc. - Hillsborough CRS, Hillsborough

07103

New Jersey Community Research Initiative, Jeffrey Bomser Clinic CRS, Newark

08861

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

07869

ID Care - Randolph CRS, Randolph Township

07083

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

08043

The Early Intervention Program at Kennedy Hosp. CRS, Voorhees Township

A-1090

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

A-1140

SMZ Baumgartner Hoehe, Immunambulanz Pavillion Wienerwald Parterre CRS, Vienna

04121-000

Centro de Referencia e Treinamento em DST/AIDS - Sao Paulo CRS, Vila Mariana

01246-900

Instituto de Infectologia Emilio Ribas CRS, São Paulo

04040-002

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

P3E 5J1

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

N5Y 3H6

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

K1H 8L6

Ottawa Hosp., Gen. Campus CRS, Ottawa

J1H 5N4

CHUS - Hopital Fleurimont, Centre de Recherche Clinique CRS, Fleurimont

H1T 2M4

Hopital Maisonneuve-Rosemont, Dept. de Microbiologie CRS, Montreal

H2L 4M1

CHUM - Campus Notre-Dame CRS, Montreal

S7N 0W8

Royal Univ. Hosp. CRS, Saskatoon

DK-8200

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

06202

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

00185

Universita La Sapienza, Clinica Universita La Sapienza CRS, Roma

1017 JZ

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

1150 AZ

Academisch Medisch Centrum CRS, Amsterdam

9713 GZ

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

41-500

Szpital Specjalistyczny, Osrodek Diagnostyki i Terapii AIDS CRS, Chorzów

71-455

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

01-201

Wojewodzki Szpital Zakazny CRS, Warsaw

51-171

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

1349-019

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

E-20011

Hosp. Donostia CRS, Donostia / San Sebastian

E-08025

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

E-08036

Hosp. Clinico de Barcelona CRS, Barcelona

E-28007

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

E-28029

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

E-28911

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

E-41013

Hosp. Virgen del Rocio, Infectious Diseases Service CRS, Seville

SE-141 86

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

CH-6903

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

BN2 1ES

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

OX3 9DU

Churchill Hosp. John Warin Ward CRS, Headington

B9 5ST

Heartlands Hosp. Dept. of Infection & Tropical Disease Outpatients CRS, Birmingham

EX1 2ED

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

LE1 5WW

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

E1 1BB

Royal London Hosp., Ambrose King Ctr. CRS, London

SE1 7EH

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

SW17 0RE

St. George's Hosp. Clinical Infection UnitCRS, London

NE4 6BE

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

S10 2JF

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

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Chiron Corporation

INDUSTRY

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH