An International Study to Evaluate Recombinant Interleukin-2 in HIV Positive Patients Taking Anti-retroviral Therapy (ESPRIT)
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Recombinant Proteins, Injections, Subcutaneous, HIV-1, Interleukin-2, Drug Therapy, Combination, CD4 Lymphocyte Count, Disease Progression, Follow-Up Studies, Anti-HIV Agents
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- VA Greater Los Angeles Healthcare System, Infectious Diseases Section CRS
- Dr. M. Estes Med. Practice CRS
- Dr. Robert Scott Med. Practice CRS
- East Bay AIDS Ctr. CRS
- Dr. Shawn Hassler Med. Practice CRS
- Positive Health Program Clinic (San Francisco Gen. Hosp.) CRS
- Positive Health Practice West/ Dr. Steve Deeks CRS
- Dr. William Owen Med. Practice CRS
- Dr. Martin Mass Med. Practice CRS
- San Francisco VAMC, Infectious Diseases Clinic CRS
- UCSF PHP, Gen. Internal Medicine Practice CRS
- Castro-Mission Health Ctr. CRS
- Dr. Virginia Cafaro Med. Practice CRS
- Denver Infectious Diseases Consultants CRS
- Denver Public Health CRS
- Univ. of Colorado Health Science Ctr. CRS
- Whitman-Walker Clinic CRS
- George Washington Univ. Med. Ctr. Infectious Diseases - Clinical Trials Unit CRS
- Walter Reed Army Med. Ctr., Infectious Disease Clinic CRS
- Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS
- Dr. Timothy A. Price Med. Practice CRS
- Miami VAMC CRS
- Univ. of Miami, Infectious Diseases Clinical Research Unit CRS
- ARCA, Central Clinc CRS
- Emory Univ. Crawford Long Hosp. CRS
- Atlanta VAMC CRS
- Klein & Slotten Medical Associates CRS
- Jesse Brown VAMC CRS
- Univ. of Illinois Family Ctr. for Infectious Disease CRS
- Lakeshore Infectious Disease Associates CRS
- North Side Family Medicine CRS
- Northwestern Memorial Physicians Group CRS
- Med. Ctr. of Louisiana at New Orleans, HIV Outpatient Clinics CRS
- Tulane University Health Sciences Center, Louisiana Community AIDS Research Program(LaCARP) CRS
- New Orleans VAMC CRS
- NIH Clinical Ctr., NIAID HIV Clinic CRS
- National Naval Med. Ctr., Infectious Diseases Special Immunology Clinic CRS
- Henry Ford Hosp. CRS
- Wayne State Univ. CRS
- St. John Hosp. & Med. Ctr., Infectious Diseases Dept. CRS
- William Beaumont Hosp., Infectious Disease Research CRS
- Abbott Northwestern Hosp., Clinic 42 CRS
- Mayo Clinic INSIGHT CRS
- Cooper Univ. Hosp. CRS
- ID Care Inc. - Hillsborough CRS
- Jersey Shore Univ. Med. Ctr. CRS
- New Jersey Community Research Initiative, Jeffrey Bomser Clinic CRS
- Cathedral Healthcare System, St. Michael's Med. Ctr. CRS
- St. Joseph's Hosp. & Med. Ctr. of New Jersey CRS
- Raritan Bay Med. Ctr., Perth Amboy Division CRS
- ID Care - Randolph CRS
- Infectious Disease Specialists of N.J., North Jersey Community Research Initiative CRS
- The Early Intervention Program at Kennedy Hosp. CRS
- Jacobi Med. Ctr., Ambulatory Care Pavillion CRS
- Bronx VAMC CRS
- St. Vincent Hosp. & Med. Ctr. CRS
- Harlem Hospital Ctr./Columbia University CRS (Gordin CTU)
- Oregon Health & Sciences Univ. Internal Medicine (L-475) CRS
- Multnomah County Health Dept., HIV Health Services Ctr. CRS
- The Research & Education Group-Portland CRS
- Providence Portland Med. Ctr., Ambulatory Care and Education Ctr. CRS
- Kaiser Immune Deficiency Clinic of Portland CRS
- Legacy Clinic Emanuel CRS
- Salem Hosp. CRS
- Kaiser Permanente Lancaster Clinic CRS
- Temple Univ. School of Medicine CRS
- Michael E. DeBakey VAMC CRS
- Northwest Clinic CRS
- Thomas Street Clinic CRS
- Univ. Clinical Research Ctr., Memorial Hermann Hosp. CRS
- Legacy Community Health Services, Inc., Montrose Clinic, Inc.
- South Texas Veterans Health Care System, Immunosuppression Clinic CRS
- Hanover Med. Park (Mechanicsville, VA) CRS
- Naval Med. Ctr. Portsmouth CRS
- CrossOver Health Ctr. CRS
- South Richmond Health Care Ctr. CRS
- Hunter Holmes McGuire VAMC CRS
- Virginia Commonwealth Univ. Medical Ctr. CRS
- Hosp. de Clinicas Jose de San Martin, Div. Infectologia CRS
- Hosp. Italiano de Buenos Aires, Infectious Diseases Section CRS
- Hosp. Gen. de Agudos JM Ramos Mejia, Servicio de Inmunocomprometidos CRS
- Hospital de Infecciosas F.J. Muniz CRS
- Funcei Crs
- Hosp. Gen. de Agudos Juan A. Fernandez CRS
- Hosp. Gen. de Agudos 'Teodoro Alvarez' CRS
- Hospital Nacional Professor Alejandro Posadas CRS
- Hospital Interzonal de Agudos Oscar Alende, Sala de Infectologia CRS
- Caici Crs
- Hosp. Rawson CRS
- Hosp. Interzonal de Agudos San Juan de Dios CRS
- Hosp. Central, Immunology Dept. CRS
- Interchange General Practice CRS
- Canberra Hosp., Canberra Sexual Health Clinic CRS
- Burwood Road Gen. Practice CRS
- St. Vincent's Hospital CRS
- Taylor Square Private Clinic CRS
- Holdsworth House Gen. Practice CRS
- John Hunter Hosp., Immunology & Infectious Diseases Unit CRS
- 407 Doctors CRS
- Albion Street Ctr. CRS
- Queensland Health - AIDS Med. Unit CRS
- Cairns Base Hosp., Sexual Health Services CRS
- Gladstone Road Medical Ctr. CRS
- Nambour Gen. Hosp. CRS
- Royal Adelaide Hosp. CRS
- The Care & Prevention Programme CRS
- Carlton Clinic CRS
- The Alfred Hosp., Clinical Research - Infectious Diseases Unit CRS
- Prahran Market Clinic CRS
- Northcote Clinic CRS
- Royal Melbourne Hosp., Victorian Infectious Diseases Service CRS
- The Ctr. Clinic INSIGHT CRS
- Royal Perth Hospital CRS
- Gold Coast Sexual Health Clinic CRS
- Univ. of Vienna Med. School, Div. of Allergy, Immunology & Infectious Diseases - Sued B CRS
- SMZ Baumgartner Hoehe, Immunambulanz Pavillion Wienerwald Parterre CRS
- Ctr. Hospitalier Universitaire, St Pierre, Div. of Infectious Diseases (PL5) CRS
- Centro de Referencia e Treinamento em DST/AIDS - Sao Paulo CRS
- Instituto de Infectologia Emilio Ribas CRS
- Universidade Federal de Sao Paulo,IDIPA-Instituto Paulista de Doencas Infecciosas e Parasitarias CRS
- Univ. of Alberta Hosp., Clinical Research Office CRS
- Cool Aid Community Health Ctr. CRS
- Q.E. II Health Sciences Ctr., Captial District Authority, Victoria Gen. Hosp. CRS
- McMaster Univ. Med. Ctr. Hamiton Health Sciences, SIS Clinic CRS
- St. Joseph's Health Ctr. of London, HIV Care Programme CRS
- Ottawa Hosp., Gen. Campus CRS
- The HAVEN Program, Sudbury Regional Hosp., Laurentian Site CRS
- Toronto Gen. Hosp. Infectious Diseases CRS
- Windsor Regional Hosp., HIV Care Program CRS
- CHUS - Hopital Fleurimont, Centre de Recherche Clinique CRS
- Hopital Maisonneuve-Rosemont, Dept. de Microbiologie CRS
- CHUM - Campus Notre-Dame CRS
- Royal Victoria Hosp., Montreal Chest Institute CRS
- Centre Hospitalier Universitaire de Quebec - CHUL, Centre de Recherche en Indectiologie CRS
- Royal Univ. Hosp. CRS
- Aalborg Hosp., Dept. of Infectious Diseases CRS
- Skejby Sygehus, Department of Infectious Diseases Q (ambulatoriet) CRS
- Rigshospitalet, Department of Infectious Diseases, M5112 CRS
- Hvidovre Univ. Hosp., Dept. of Infectious Diseases CRS
- Odense Univ. Hosp., Med. Dept. C CRS
- Centre Hospitalier de la Region Annecienne, Service des Maladie Infectieuses CRS
- CHRU d'Angers, Service de Maladies Infectieuses CRS
- Hopital Saint-Jacques, Service des Maladies Infectieuses et Tropicales CRS
- Hopital Avicenne, Service de Medecine B CRS
- Hopital Antoine Beclere Service d'Immunologie Clinique CRS
- Hopital Louis Mourier, Service de Medecine Interne CRS
- Hopital Henri Mondor, Immunopathologie Clinique CRS
- Hopital Raymond Poincare - Vidal 2, Service des Maladies Infectieuses et Tropicales CRS
- Hopital de Bicetre, Service de Medecine Interne CRS
- Hopital Sainte Marguerite, CISIH Hopital de Jour CRS
- Hopital de la Conception, Service des Maladies Infectieuses CRS
- Hopital Gui de Chauliac, Service des Maladies Infectieuses et Tropicales CRS
- Hopital de l'Archet 1, Service de Medecine Interne 2 Hematologie Clinique CRS
- Hopital Saint-Antoine, Service de Maladies Infectieuses CRS
- Hopital de La Salpetriere, Service de Medecine Interne CRS
- Hopital Cochin, Service de Medecine Interne 2 CRS
- Hopital Necker, Service des Maladies Infectieuses CRS
- Hopital Europeen Georges Pompidou, Service d'Immunologie Clinique CRS
- Hopital Tenon, Service de Maladies Infectieuses et Tropicales CRS
- C.H.U. Bichat - Claude Bernard Service des Maladies Infectieuses et Tropicales CRS
- CHRU de Strasbourg (France) CRS
- Hopital Foch, Service de Medecine Interne CRS
- Univ. Hosp. Charite, Dept of Infectious Diseases CRS
- Ruhr-Univ., Interdiszipl. Immunolog. Ambulanz CRS
- Medizinische Universitaetsklinik - Bonn, Immunologische Ambulanz CRS
- Ctr. for HIV & Hepatogastroenterology, HIV Specialised Practice (Private Practice) CRS
- Johann Wolfgang Goethe Univ. Hosp., Infektionsambulanz CRS
- IPM Study Ctr. (Hamburg) CRS
- Univ. Hosp. Heidelberg, Dept. of Dermatology CRS
- Klinik I fur Innere Medizin der Universitat zu Koln, Studienburo fur Infektiologie u. HIV CRS
- Klinikum Innenstadt, Infektionsambulanz und Tagesklinik CRS
- Univ. of Wuerzburg, Medizinische Poliklinik, Schwerpunkt Hepatologie/Infektiologie CRS
- St. James' Hosp., Guide Clinic CRS
- Rambam Med. Ctr., Immunology, Allergy & AIDS Institute, B. Rappaport Faculty of Medicine, Technion
- Kaplan Med. Ctr., Ben Ari Institute of Clinical Immunology CRS
- Tel Aviv Sourasky Med. Ctr., Clinical Immunology Unit and AIDS Ctr. CRS
- Civili di Brescia, 1st Division of Infectious Diseases CRS
- Civili di Brescia, Dept of Infectious & Tropical Disease, Hosp.Spedali Civili of Brescia CRS
- Ospedale S. Maria Annunziata, U.O. Malattie Infettive CRS
- Ospedale San Raffaele, Centro San Luigi - Divisione Malattie Infettive CRS
- Univ. of Milan, Ospedale Luigi Sacco, Institute of Infectious and Tropical Diseases CRS
- Universita degli Studi di Modena e Reggio Emilia, Clinica delle Malattie Infettive e Tropicali CRS
- San Matteo Hospital - University of Pavia, Division of Infectious and Tropical Diseases CRS
- Universita La Sapienza, Clinica Universita La Sapienza CRS
- Osaka National Hosp. AIDS Ctr., Clinical Research Institute CRS
- International Med. Ctr. of Japan CRS
- Univ. of Tokyo, Research Hosp. of the Institute of Medical Science CRS
- Univ. Hosp. Ctr. of the Med. School of Casablanca, Infectious Diseases Unit CRS
- OLVG -- locatie Prinsengracht, Dept. of Internal Medicine II CRS
- Academisch Medisch Centrum CRS
- Stichting Medisch Centrum Jan van Goyen, Dept. of Internal Medicine CRS
- Groningen Univ. Hosp., Department of Internal Medicine CRS
- Kennemer Gasthuis, Lokatie EG CRS
- St. Elisabeth Ziekenhuis CRS
- Ulleval Hosp., Dept. of Infectious Diseases CRS
- Szpital Specjalistyczny, Osrodek Diagnostyki i Terapii AIDS CRS
- Pomeranian Academy of Medicine (PAM), Dept. of Infectious Diseases and Hepatology CRS
- Wojewodzki Szpital Zakazny CRS
- Wroclaw Univ., School of Med., Dept. of Infectious Diseases, Liver Diseases and AIDS CRS
- Hospital de Cascais, HDDI, Departamento Medicina Interna CRS
- Hosp. de Egas Moniz, Servicio de Infecciologia e Medicina Tropical CRS
- Hosp. de Santa Maria, Servico de Doencas Infecciosas CRS
- Tan Tock Seng Hosp., Infectious Diseases Research Ctr. CRS
- Hosp. Donostia CRS
- Hosp. Juan Canalejo, Dept. of Internal Medicine CRS
- Hosp. Santa Creu i Sant Pau, Servicio de Medicina Interna CRS
- Hosp. Clinico de Barcelona CRS
- Hosp. del Mar, Internal Medicine-Infectious Diseases CRS
- Hosp. Universitari Germans Trias i Pujol, HIV Unit and Retrovirology Lab. CRS
- Hosp. Universitario Gregorio Maranion, Microbiology & Infectious Diseases Unit CRS
- Centro de Investigacion Carlos III, Infectious Diseases Dept. CRS
- Hosp. Severo Ochoa, Internal Medicine and Infectious Diseases CRS
- Hosp. 12 de Octubre, Pabellon de Medicina Communitaria CRS
- Hosp. Clinico San Carlos CRS
- Hosp. la Princesa, Internal Medicine and Infectious Diseases Service CRS
- Hosp. Ramon y Cajal (Madrid) CRS
- Hosp. Universitario La Paz CRS
- Hosp. Universitario Principe de Asturias CRS
- Hosp. Universitario Morales Meseguer CRS
- Hosp. Virgen del Rocio, Infectious Diseases Service CRS
- Karolinska Univ. Hosp. Huddinge, Dept. of Infectious Diseases CRS
- Venhalsan, Soder Hosp., Dept. of Infectious Diseases, Karolinska Univ. Hosp. CRS
- Regional Hosp. of Lugano (Sede Civico), Ospedale Civico di Lugano, Infectious Diseases Unit CRS
- Siriraj Hosp., Mahidol Univ. INSIGHT CRS
- Chulalongkorn Univ. Hosp., HIV-NAT Research Collaboration CRS
- Chiang Rai Regional Hosp. INSIGHT CRS
- Chonburi Regional Hosp., Dept. of Internal Medicine CRS
- Khon Kaen Univ., Srinagarind Hosp., Div. of Infectious Diseases & Tropical Medicine, Dept. of Medici
- Brighton & Sussex Univ. Hosp. NHS Trust, HIV Research Office CRS
- Royal Victoria Hosp. Dept. of Genitourinary Medicine CRS
- Churchill Hosp. John Warin Ward CRS
- Western Gen. Hosp., Regional Infectious Diseases Unit CRS
- Gartnaval Gen. Hosp., Brownlee Ctr. CRS
- Heartlands Hosp. Dept. of Infection & Tropical Disease Outpatients CRS
- Royal Devon & Exeter NHS Foundation Trust, Heavitree Hosp., Dept. of GU Medicine CRS
- Leicester Royal Infirmary, Dept. of Infection & Tropical Medicine CRS
- Royal London Hosp., Ambrose King Ctr. CRS
- St. Thomas' Hosp., Dept. of GU Medicine CRS
- St. George's Hosp. Clinical Infection UnitCRS
- Chelsea & Westminster Hosp., St. Stephens Ctr. CRS
- King's College Hosp., Caldecot Ctr. Dept. of Sexual Health CRS
- Royal Free Hosp., Dept. of Infection & Immunity, Ian Charleson Day Ctr. CRS
- St. Bartholomew's Hosp., Infection & Immunity Clinical Group CRS
- St. Mary's Hosp. of London, Imperial College School of Medicine CRS
- Univ. College London Med. School, Ctr. for Sexual Health & HIV Research CRS
- Newcastle Gen. Hosp., Dept of Infection & Tropical Medicine CRS
- Edith Cavell Hosp. Dept. of Sexual Health, Clinic E CRS
- Royal Hallamshire Hosp., Dept. of GU Medicine Communicable Diseases Unit CRS
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
rIL-2
No rIL-2
Recombinant interleukin-2 (rIL-2) therapy used with combination anti-HIV medication of choice.
Control arm uses anti-HIV medication of choice without rIL-2.