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

HIV Infections Clinical Trial

— ESPRIT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004978
• Other study ID #: ESPRIT 001
• Secondary ID: 5U01AI04695700 I
• Status: Completed
• Phase: Phase 3
• Start date: March 2000
• Est. completion date: November 2008

Study information

• Verified date: October 2012
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Other known NCT identifiers

• NCT00004737

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4150
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections
• Infections

Intervention

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.

Locations

Country	Name	City	State
Argentina	Funcei Crs	Ciudad de Buenos Aires	Buenos Aires
Argentina	Hosp. de Clinicas Jose de San Martin, Div. Infectologia CRS	Ciudad de Buenos Aires	Buenos Aires
Argentina	Hosp. Gen. de Agudos 'Teodoro Alvarez' CRS	Ciudad de Buenos Aires	Buenos Aires
Argentina	Hosp. Gen. de Agudos JM Ramos Mejia, Servicio de Inmunocomprometidos CRS	Ciudad de Buenos Aires	Buenos Aires
Argentina	Hosp. Gen. de Agudos Juan A. Fernandez CRS	Ciudad de Buenos Aires	Buenos Aires
Argentina	Hosp. Italiano de Buenos Aires, Infectious Diseases Section CRS	Ciudad de Buenos Aires	Buenos Aires
Argentina	Hospital de Infecciosas F.J. Muniz CRS	Ciudad de Buenos Aires	Buenos Aires
Argentina	Hosp. Rawson CRS	Cordoba
Argentina	Hospital Nacional Professor Alejandro Posadas CRS	El Palomar	Buenos Aires
Argentina	Hosp. Interzonal de Agudos San Juan de Dios CRS	La Plata
Argentina	Hospital Interzonal de Agudos Oscar Alende, Sala de Infectologia CRS	Mar del Plata	Buenos Aires
Argentina	Hosp. Central, Immunology Dept. CRS	Mendoza
Argentina	Caici Crs	Rosario	Provincia De Santa Fe
Australia	Royal Adelaide Hosp. CRS	Adelaide	South Australia
Australia	The Care & Prevention Programme CRS	Adelaide	South Australia
Australia	Queensland Health - AIDS Med. Unit CRS	Brisbane	Queensland
Australia	Burwood Road Gen. Practice CRS	Burwood	New South Wales
Australia	Cairns Base Hosp., Sexual Health Services CRS	Cairns	Queensland
Australia	Interchange General Practice CRS	Canberra	Australian Capital Territory
Australia	Carlton Clinic CRS	Carlton	Victoria
Australia	Holdsworth House Gen. Practice CRS	Darlinghurst	New South Wales
Australia	St. Vincent's Hospital CRS	Darlinghurst	New South Wales
Australia	Taylor Square Private Clinic CRS	Darlinghurst	New South Wales
Australia	Gladstone Road Medical Ctr. CRS	Highgate Hill	Queensland
Australia	Prahran Market Clinic CRS	Melbourne	Victoria
Australia	The Alfred Hosp., Clinical Research - Infectious Diseases Unit CRS	Melbourne	Victoria
Australia	Gold Coast Sexual Health Clinic CRS	Miami, Queensland
Australia	Nambour Gen. Hosp. CRS	Nambour	Queensland
Australia	John Hunter Hosp., Immunology & Infectious Diseases Unit CRS	Newcastle	New South Wales
Australia	Northcote Clinic CRS	Northcote	Victoria
Australia	Royal Melbourne Hosp., Victorian Infectious Diseases Service CRS	Parkville	Victoria
Australia	Royal Perth Hospital CRS	Perth	Western Australia
Australia	The Ctr. Clinic INSIGHT CRS	St. Kilda	Victoria
Australia	407 Doctors CRS	Surry Hills	New South Wales
Australia	Albion Street Ctr. CRS	Surry Hills	New South Wales
Australia	Canberra Hosp., Canberra Sexual Health Clinic CRS	Woden	Australian Capital Territory
Austria	Univ. of Vienna Med. School, Div. of Allergy, Immunology & Infectious Diseases - Sued B CRS	Vienna
Austria	SMZ Baumgartner Hoehe, Immunambulanz Pavillion Wienerwald Parterre CRS	Wien
Belgium	Ctr. Hospitalier Universitaire, St Pierre, Div. of Infectious Diseases (PL5) CRS	Bruxelles
Brazil	Instituto de Infectologia Emilio Ribas CRS	Sao Paulo
Brazil	Universidade Federal de Sao Paulo,IDIPA-Instituto Paulista de Doencas Infecciosas e Parasitarias CRS	Sao Paulo
Brazil	Centro de Referencia e Treinamento em DST/AIDS - Sao Paulo CRS	Vila Mariana	Sao Paulo
Canada	Univ. of Alberta Hosp., Clinical Research Office CRS	Edmonton	Alberta
Canada	CHUS - Hopital Fleurimont, Centre de Recherche Clinique CRS	Fleurimont	Quebec
Canada	Q.E. II Health Sciences Ctr., Captial District Authority, Victoria Gen. Hosp. CRS	Halifax	Nova Scotia
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
Canada	CHUM - Campus Notre-Dame CRS	Montreal	Quebec
Canada	Hopital Maisonneuve-Rosemont, Dept. de Microbiologie CRS	Montreal	Quebec
Canada	Royal Victoria Hosp., Montreal Chest Institute CRS	Montreal	Quebec
Canada	Ottawa Hosp., Gen. Campus CRS	Ottawa	Ontario
Canada	Centre Hospitalier Universitaire de Quebec - CHUL, Centre de Recherche en Indectiologie CRS	Sainte-Foy	Quebec
Canada	Royal Univ. Hosp. CRS	Saskatoon	Saskatchewan
Canada	The HAVEN Program, Sudbury Regional Hosp., Laurentian Site CRS	Sudbury	Ontario
Canada	Toronto Gen. Hosp. Infectious Diseases CRS	Toronto	Ontario
Canada	Cool Aid Community Health Ctr. CRS	Victoria	British Columbia
Canada	Windsor Regional Hosp., HIV Care Program CRS	Windsor	Ontario
Denmark	Aalborg Hosp., Dept. of Infectious Diseases CRS	Aalborg
Denmark	Skejby Sygehus, Department of Infectious Diseases Q (ambulatoriet) CRS	Aarhus
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
France	CHRU d'Angers, Service de Maladies Infectieuses CRS	Angers
France	Hopital Saint-Jacques, Service des Maladies Infectieuses et Tropicales CRS	Besancon
France	Hopital Avicenne, Service de Medecine B CRS	Bobigny
France	Centre Hospitalier de la Region Annecienne, Service des Maladie Infectieuses CRS	Cedex	Pringy
France	Hopital Antoine Beclere Service d'Immunologie Clinique CRS	Clamart
France	Hopital Louis Mourier, Service de Medecine Interne CRS	Colombes
France	Hopital Henri Mondor, Immunopathologie Clinique CRS	Creteil
France	Hopital Raymond Poincare - Vidal 2, Service des Maladies Infectieuses et Tropicales CRS	Garches
France	Hopital de Bicetre, Service de Medecine Interne CRS	Le Kremlin-Bicetre
France	Hopital de la Conception, Service des Maladies Infectieuses CRS	Marseille
France	Hopital Sainte Marguerite, CISIH Hopital de Jour CRS	Marseille
France	Hopital Gui de Chauliac, Service des Maladies Infectieuses et Tropicales CRS	Montpellier
France	Hopital de l'Archet 1, Service de Medecine Interne 2 Hematologie Clinique CRS	Nice
France	C.H.U. Bichat - Claude Bernard Service des Maladies Infectieuses et Tropicales CRS	Paris
France	Hopital Cochin, Service de Medecine Interne 2 CRS	Paris
France	Hopital de La Salpetriere, Service de Medecine Interne CRS	Paris
France	Hopital Europeen Georges Pompidou, Service d'Immunologie Clinique CRS	Paris
France	Hopital Necker, Service des Maladies Infectieuses CRS	Paris
France	Hopital Saint-Antoine, Service de Maladies Infectieuses CRS	Paris
France	Hopital Tenon, Service de Maladies Infectieuses et Tropicales CRS	Paris
France	CHRU de Strasbourg (France) CRS	Strasbourg
France	Hopital Foch, Service de Medecine Interne CRS	Suresenes
Germany	Univ. Hosp. Charite, Dept of Infectious Diseases CRS	Berlin
Germany	Ruhr-Univ., Interdiszipl. Immunolog. Ambulanz CRS	Bochum
Germany	Medizinische Universitaetsklinik - Bonn, Immunologische Ambulanz CRS	Bonn
Germany	Ctr. for HIV & Hepatogastroenterology, HIV Specialised Practice (Private Practice) CRS	Duesseldorf
Germany	Johann Wolfgang Goethe Univ. Hosp., Infektionsambulanz CRS	Frankfurt
Germany	IPM Study Ctr. (Hamburg) CRS	Hamburg
Germany	Univ. Hosp. Heidelberg, Dept. of Dermatology CRS	Heidelberg
Germany	Klinik I fur Innere Medizin der Universitat zu Koln, Studienburo fur Infektiologie u. HIV CRS	Koln
Germany	Klinikum Innenstadt, Infektionsambulanz und Tagesklinik CRS	Munchen
Germany	Univ. of Wuerzburg, Medizinische Poliklinik, Schwerpunkt Hepatologie/Infektiologie CRS	Wuerzburg
Ireland	St. James' Hosp., Guide Clinic CRS	Dublin
Israel	Rambam Med. Ctr., Immunology, Allergy & AIDS Institute, B. Rappaport Faculty of Medicine, Technion	Haifa
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
Italy	Civili di Brescia, 1st Division of Infectious Diseases CRS	Brescia
Italy	Civili di Brescia, Dept of Infectious & Tropical Disease, Hosp.Spedali Civili of Brescia CRS	Brescia
Italy	Ospedale S. Maria Annunziata, U.O. Malattie Infettive CRS	Firenze
Italy	Ospedale San Raffaele, Centro San Luigi - Divisione Malattie Infettive CRS	Milano
Italy	Univ. of Milan, Ospedale Luigi Sacco, Institute of Infectious and Tropical Diseases CRS	Milano
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
Italy	Universita La Sapienza, Clinica Universita La Sapienza CRS	Roma
Japan	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
Morocco	Univ. Hosp. Ctr. of the Med. School of Casablanca, Infectious Diseases Unit CRS	Casablanca
Netherlands	Academisch Medisch Centrum CRS	Amsterdam
Netherlands	OLVG -- locatie Prinsengracht, Dept. of Internal Medicine II CRS	Amsterdam
Netherlands	Stichting Medisch Centrum Jan van Goyen, Dept. of Internal Medicine CRS	Amsterdam
Netherlands	Groningen Univ. Hosp., Department of Internal Medicine CRS	Groningen
Netherlands	Kennemer Gasthuis, Lokatie EG CRS	Haarlem
Netherlands	St. Elisabeth Ziekenhuis CRS	Tilburg
Norway	Ulleval Hosp., Dept. of Infectious Diseases CRS	Oslo
Poland	Szpital Specjalistyczny, Osrodek Diagnostyki i Terapii AIDS CRS	Chorzow
Poland	Pomeranian Academy of Medicine (PAM), Dept. of Infectious Diseases and Hepatology CRS	Szczecin
Poland	Wojewodzki Szpital Zakazny CRS	Warsaw
Poland	Wroclaw Univ., School of Med., Dept. of Infectious Diseases, Liver Diseases and AIDS CRS	Wroclaw
Portugal	Hospital de Cascais, HDDI, Departamento Medicina Interna CRS	Cascais
Portugal	Hosp. de Egas Moniz, Servicio de Infecciologia e Medicina Tropical CRS	Lisboa
Portugal	Hosp. de Santa Maria, Servico de Doencas Infecciosas CRS	Lisboa
Singapore	Tan Tock Seng Hosp., Infectious Diseases Research Ctr. CRS	Singapore
Spain	Hosp. Juan Canalejo, Dept. of Internal Medicine CRS	A Coruna
Spain	Hosp. Clinico de Barcelona CRS	Barcelona
Spain	Hosp. del Mar, Internal Medicine-Infectious Diseases CRS	Barcelona
Spain	Hosp. Santa Creu i Sant Pau, Servicio de Medicina Interna CRS	Barcelona
Spain	Hosp. Universitari Germans Trias i Pujol, HIV Unit and Retrovirology Lab. CRS	Barcelona
Spain	Centro de Investigacion Carlos III, Infectious Diseases Dept. CRS	Madrid
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. Severo Ochoa, Internal Medicine and Infectious Diseases CRS	Madrid
Spain	Hosp. Universitario Gregorio Maranion, Microbiology & Infectious Diseases Unit 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. Donostia CRS	San Sebastian	Guipuzcoa
Spain	Hosp. Virgen del Rocio, Infectious Diseases Service CRS	Sevilla
Sweden	Karolinska Univ. Hosp. Huddinge, Dept. of Infectious Diseases CRS	Stockholm
Sweden	Venhalsan, Soder Hosp., Dept. of Infectious Diseases, Karolinska Univ. Hosp. CRS	Stockholm
Switzerland	Regional Hosp. of Lugano (Sede Civico), Ospedale Civico di Lugano, Infectious Diseases Unit CRS	Lugano	Ticino
Thailand	Chulalongkorn Univ. Hosp., HIV-NAT Research Collaboration CRS	Bangkok	Ratchathewi
Thailand	Siriraj Hosp., Mahidol Univ. INSIGHT CRS	Bangkok	Ratchathewi
Thailand	Chiang Rai Regional Hosp. INSIGHT CRS	Chiangrai
Thailand	Chonburi Regional Hosp., Dept. of Internal Medicine CRS	Chonburi
Thailand	Khon Kaen Univ., Srinagarind Hosp., Div. of Infectious Diseases & Tropical Medicine, Dept. of Medici	Khon Kaen
United Kingdom	Royal Victoria Hosp. Dept. of Genitourinary Medicine CRS	Belfast	Northern Ireland
United Kingdom	Heartlands Hosp. Dept. of Infection & Tropical Disease Outpatients CRS	Birmingham
United Kingdom	Western Gen. Hosp., Regional Infectious Diseases Unit CRS	Edinburgh	Scotland
United Kingdom	Brighton & Sussex Univ. Hosp. NHS Trust, HIV Research Office CRS	Elm Grove	Brighton
United Kingdom	Royal Devon & Exeter NHS Foundation Trust, Heavitree Hosp., Dept. of GU Medicine CRS	Exeter
United Kingdom	Gartnaval Gen. Hosp., Brownlee Ctr. CRS	Glasgow	Scotland
United Kingdom	Churchill Hosp. John Warin Ward CRS	Headington	Oxford
United Kingdom	Leicester Royal Infirmary, Dept. of Infection & Tropical Medicine CRS	Leicester
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	Royal London Hosp., Ambrose King Ctr. CRS	London
United Kingdom	St. Bartholomew's Hosp., Infection & Immunity Clinical Group CRS	London
United Kingdom	St. George's Hosp. Clinical Infection UnitCRS	London
United Kingdom	St. Mary's Hosp. of London, Imperial College School of Medicine CRS	London
United Kingdom	St. Thomas' Hosp., Dept. of GU 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
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
United States	ARCA, Central Clinc CRS	Atlanta	Georgia
United States	Emory Univ. Crawford Long Hosp. CRS	Atlanta	Georgia
United States	National Naval Med. Ctr., Infectious Diseases Special Immunology Clinic CRS	Bethesda	Maryland
United States	NIH Clinical Ctr., NIAID HIV Clinic CRS	Bethesda	Maryland
United States	Bronx VAMC CRS	Bronx	New York
United States	Jacobi Med. Ctr., Ambulatory Care Pavillion CRS	Bronx	New York
United States	Cooper Univ. Hosp. CRS	Camden	New Jersey
United States	Jesse Brown VAMC CRS	Chicago	Illinois
United States	Klein & Slotten Medical Associates CRS	Chicago	Illinois
United States	Lakeshore Infectious Disease Associates CRS	Chicago	Illinois
United States	North Side Family Medicine CRS	Chicago	Illinois
United States	Northwestern Memorial Physicians Group CRS	Chicago	Illinois
United States	Univ. of Illinois Family Ctr. for Infectious Disease CRS	Chicago	Illinois
United States	Atlanta VAMC CRS	Decatur	Georgia
United States	Denver Infectious Diseases Consultants CRS	Denver	Colorado
United States	Denver Public Health CRS	Denver	Colorado
United States	Univ. of Colorado Health Science Ctr. CRS	Denver	Colorado
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
United States	ID Care Inc. - Hillsborough CRS	Hillsborough	New Jersey
United States	Legacy Community Health Services, Inc., Montrose Clinic, Inc.	Houston	Texas
United States	Michael E. DeBakey VAMC CRS	Houston	Texas
United States	Northwest Clinic CRS	Houston	Texas
United States	Thomas Street Clinic CRS	Houston	Texas
United States	Univ. Clinical Research Ctr., Memorial Hermann Hosp. CRS	Houston	Texas
United States	VA Greater Los Angeles Healthcare System, Infectious Diseases Section CRS	Los Angeles	California
United States	Hanover Med. Park (Mechanicsville, VA) CRS	Mechanicsville	Virginia
United States	Miami VAMC CRS	Miami	Florida
United States	Univ. of Miami, Infectious Diseases Clinical Research Unit CRS	Miami	Florida
United States	Dr. M. Estes Med. Practice CRS	Mill Valley	California
United States	Abbott Northwestern Hosp., Clinic 42 CRS	Minneapolis	Minnesota
United States	Jersey Shore Univ. Med. Ctr. CRS	Neptune	New Jersey
United States	Med. Ctr. of Louisiana at New Orleans, HIV Outpatient Clinics CRS	New Orleans	Louisiana
United States	New Orleans VAMC CRS	New Orleans	Louisiana
United States	Tulane University Health Sciences Center, Louisiana Community AIDS Research Program(LaCARP) CRS	New Orleans	Louisiana
United States	Harlem Hospital Ctr./Columbia University CRS (Gordin CTU)	New York	New York
United States	St. Vincent Hosp. & Med. Ctr. CRS	New York	New York
United States	Cathedral Healthcare System, St. Michael's Med. Ctr. CRS	Newark	New Jersey
United States	New Jersey Community Research Initiative, Jeffrey Bomser Clinic CRS	Newark	New Jersey
United States	Dr. Robert Scott Med. Practice CRS	Oakland	California
United States	East Bay AIDS Ctr. CRS	Oakland	California
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
United States	Temple Univ. School of Medicine CRS	Philadelphia	Pennsylvania
United States	Kaiser Immune Deficiency Clinic of Portland CRS	Portland	Oregon
United States	Legacy Clinic Emanuel CRS	Portland	Oregon
United States	Multnomah County Health Dept., HIV Health Services Ctr. CRS	Portland	Oregon
United States	Oregon Health & Sciences Univ. Internal Medicine (L-475) CRS	Portland	Oregon
United States	Providence Portland Med. Ctr., Ambulatory Care and Education Ctr. CRS	Portland	Oregon
United States	The Research & Education Group-Portland CRS	Portland	Oregon
United States	Naval Med. Ctr. Portsmouth CRS	Portsmouth	Virginia
United States	ID Care - Randolph CRS	Randolph	New Jersey
United States	CrossOver Health Ctr. CRS	Richmond	Virginia
United States	Hunter Holmes McGuire VAMC CRS	Richmond	Virginia
United States	South Richmond Health Care Ctr. CRS	Richmond	Virginia
United States	Virginia Commonwealth Univ. Medical Ctr. CRS	Richmond	Virginia
United States	Mayo Clinic INSIGHT CRS	Rochester	Minnesota
United States	William Beaumont Hosp., Infectious Disease Research CRS	Royal Oak	Michigan
United States	Kaiser Permanente Lancaster Clinic CRS	Salem	Oregon
United States	Salem Hosp. CRS	Salem	Oregon
United States	South Texas Veterans Health Care System, Immunosuppression Clinic CRS	San Antonio	Texas
United States	Castro-Mission Health Ctr. CRS	San Francisco	California
United States	Dr. Martin Mass Med. Practice CRS	San Francisco	California
United States	Dr. Shawn Hassler Med. Practice CRS	San Francisco	California
United States	Dr. Virginia Cafaro Med. Practice CRS	San Francisco	California
United States	Dr. William Owen Med. Practice CRS	San Francisco	California
United States	Positive Health Practice West/ Dr. Steve Deeks CRS	San Francisco	California
United States	Positive Health Program Clinic (San Francisco Gen. Hosp.) CRS	San Francisco	California
United States	San Francisco VAMC, Infectious Diseases Clinic CRS	San Francisco	California
United States	UCSF PHP, Gen. Internal Medicine Practice CRS	San Francisco	California
United States	Infectious Disease Specialists of N.J., North Jersey Community Research Initiative CRS	Union	New Jersey
United States	The Early Intervention Program at Kennedy Hosp. CRS	Voorhees	New Jersey
United States	Dr. Timothy A. Price Med. Practice CRS	Washington	District of Columbia
United States	George Washington Univ. Med. Ctr. Infectious Diseases - Clinical Trials Unit CRS	Washington	District of Columbia
United States	Walter Reed Army Med. Ctr., Infectious Disease Clinic CRS	Washington	District of Columbia
United States	Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS	Washington	District of Columbia
United States	Whitman-Walker Clinic CRS	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Chiron Corporation

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Denmark,  France,  Germany,  Ireland,  Israel,  Italy,  Japan,  Morocco,  Netherlands,  Norway,  Poland,  Portugal,  Singapore,  Spain,  Sweden,  Switzerland,  Thailand,  United Kingdom, 

References & Publications (5)

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; ESPR — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

INSIGHT-ESPRIT Study Group; SILCAAT Scientific Committee, Abrams D, Lévy 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. Int — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	from randomization through study end - median of 7.6 years follow-up
Secondary	Number of Participants Who Died From Any Cause		from randomization through study end - median of 7.6 years follow-up
Secondary	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	from randomization through 15 November 2008 - median of 7.6 years follow-up
Secondary	Absolute CD4 Cell Counts Averaged Throughout Followup	Average of all available CD4+ cell counts measured at follow-up visits	from randomization through study end - median of 7.6 years follow-up
Secondary	Plasma HIV RNA Levels	log10 HIV-RNA averaged throughout follow-up	From randomization through study end - median of 7.6 years follow-up
Secondary	Number of Participants With Changes in Anti-retroviral Treatment (ART)	Number of participants who changed ART at least once during the study period.	From randomization through study end - median of 7.6 years follow-up
Secondary	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.	From randomization through study end - median of 7.6 years follow-up
Secondary	Pattern of Use of Prophylaxis for Opportunistic Infections	Number of participants using pneumocystis pneumonia (PCP) prophylaxis at the last attended followup visit.	last followup visit - median of 7.6 years follow-up
Secondary	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.	From randomization through study end - median of 7.6 years follow-up

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