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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Recombinant interleukin-2 (rIL-2)
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

No Intervention

Arm Label

rIL-2

No rIL-2

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Number of Participants Who Died From Any Cause
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
Absolute CD4 Cell Counts Averaged Throughout Followup
Average of all available CD4+ cell counts measured at follow-up visits
Plasma HIV RNA Levels
log10 HIV-RNA averaged throughout follow-up
Number of Participants With Changes in Anti-retroviral Treatment (ART)
Number of participants who changed ART at least once during the study period.
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.
Pattern of Use of Prophylaxis for Opportunistic Infections
Number of participants using pneumocystis pneumonia (PCP) prophylaxis at the last attended followup visit.
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.

Full Information

First Posted
March 10, 2000
Last Updated
November 2, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Chiron Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00004978
Brief Title
An International Study to Evaluate Recombinant Interleukin-2 in HIV Positive Patients Taking Anti-retroviral Therapy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
March 2000 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Chiron Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to see if it is effective to give HIV positive patients recombinant interleukin-2 (rIL-2) in addition to anti-HIV therapy. Patients will be followed over a minimum of 4 years to study the long-term effects of rIL-2 on their HIV disease progression. Anti-HIV therapy has been very successful in treating HIV positive patients and in keeping viral load (level of HIV in the blood) low. However, anti-HIV drugs cannot completely rid the body of the virus, and the immune system is never completely restored in HIV positive patients. Doctors hope that giving patients recombinant interleukin-2 (rIL-2) in addition to their anti-HIV therapy will help improve their immune systems and keep them healthier over a longer period of time. rIL-2 is a hormone naturally produced by the body during an immune response to a microbial infection.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Recombinant Proteins, Injections, Subcutaneous, HIV-1, Interleukin-2, Drug Therapy, Combination, CD4 Lymphocyte Count, Disease Progression, Follow-Up Studies, Anti-HIV Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rIL-2
Arm Type
Experimental
Arm Description
Recombinant interleukin-2 (rIL-2) therapy used with combination anti-HIV medication of choice.
Arm Title
No rIL-2
Arm Type
No Intervention
Arm Description
Control arm uses anti-HIV medication of choice without rIL-2.
Intervention Type
Drug
Intervention Name(s)
Recombinant interleukin-2 (rIL-2)
Other Intervention Name(s)
Proleukin, IL-2, Aldesleukin
Intervention Description
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.
Primary Outcome Measure Information:
Title
New or Recurrent HIV Disease Progression Event Including Death
Description
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
Time Frame
from randomization through study end - median of 7.6 years follow-up
Secondary Outcome Measure Information:
Title
New or Recurrent Serious HIV Disease Progression Event Including Death
Description
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.
Time Frame
from randomization through study end - median of 7.6 years follow-up
Title
Number of Participants Who Died From Any Cause
Time Frame
from randomization through study end - median of 7.6 years follow-up
Title
Participants With a New Disease Progression Event or Death
Description
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
Time Frame
from randomization through 15 November 2008 - median of 7.6 years follow-up
Title
Absolute CD4 Cell Counts Averaged Throughout Followup
Description
Average of all available CD4+ cell counts measured at follow-up visits
Time Frame
from randomization through study end - median of 7.6 years follow-up
Title
Plasma HIV RNA Levels
Description
log10 HIV-RNA averaged throughout follow-up
Time Frame
From randomization through study end - median of 7.6 years follow-up
Title
Number of Participants With Changes in Anti-retroviral Treatment (ART)
Description
Number of participants who changed ART at least once during the study period.
Time Frame
From randomization through study end - median of 7.6 years follow-up
Title
Grade 4 Signs and Symptoms
Description
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.
Time Frame
From randomization through study end - median of 7.6 years follow-up
Title
Pattern of Use of Prophylaxis for Opportunistic Infections
Description
Number of participants using pneumocystis pneumonia (PCP) prophylaxis at the last attended followup visit.
Time Frame
last followup visit - median of 7.6 years follow-up
Title
Hepatic, Metabolic, and Cardiac Conditions
Description
Number of participants experiencing a "serious non-AIDS" event defined as first serious cardiovascular, renal, or hepatic event, or non-AIDS malignancy.
Time Frame
From randomization through study end - median of 7.6 years follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Abrams, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marcelo Losso, MD
Organizational Affiliation
Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina
Official's Role
Study Chair
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System, Infectious Diseases Section CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Dr. M. Estes Med. Practice CRS
City
Mill Valley
State/Province
California
ZIP/Postal Code
94941-3013
Country
United States
Facility Name
Dr. Robert Scott Med. Practice CRS
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
East Bay AIDS Ctr. CRS
City
Oakland
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Dr. Shawn Hassler Med. Practice CRS
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Facility Name
Positive Health Program Clinic (San Francisco Gen. Hosp.) CRS
City
San Francisco
State/Province
California
ZIP/Postal Code
94110-0242
Country
United States
Facility Name
Positive Health Practice West/ Dr. Steve Deeks CRS
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Dr. William Owen Med. Practice CRS
City
San Francisco
State/Province
California
ZIP/Postal Code
94114-1010
Country
United States
Facility Name
Dr. Martin Mass Med. Practice CRS
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
San Francisco VAMC, Infectious Diseases Clinic CRS
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
UCSF PHP, Gen. Internal Medicine Practice CRS
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Castro-Mission Health Ctr. CRS
City
San Francisco
State/Province
California
ZIP/Postal Code
94144
Country
United States
Facility Name
Dr. Virginia Cafaro Med. Practice CRS
City
San Francisco
State/Province
California
Country
United States
Facility Name
Denver Infectious Diseases Consultants CRS
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204-4507
Country
United States
Facility Name
Denver Public Health CRS
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Univ. of Colorado Health Science Ctr. CRS
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Whitman-Walker Clinic CRS
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20009
Country
United States
Facility Name
George Washington Univ. Med. Ctr. Infectious Diseases - Clinical Trials Unit CRS
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Walter Reed Army Med. Ctr., Infectious Disease Clinic CRS
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307
Country
United States
Facility Name
Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Dr. Timothy A. Price Med. Practice CRS
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Miami VAMC CRS
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Univ. of Miami, Infectious Diseases Clinical Research Unit CRS
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
ARCA, Central Clinc CRS
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Emory Univ. Crawford Long Hosp. CRS
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Atlanta VAMC CRS
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Klein & Slotten Medical Associates CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Jesse Brown VAMC CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Univ. of Illinois Family Ctr. for Infectious Disease CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Lakeshore Infectious Disease Associates CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
North Side Family Medicine CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Northwestern Memorial Physicians Group CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Med. Ctr. of Louisiana at New Orleans, HIV Outpatient Clinics CRS
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Tulane University Health Sciences Center, Louisiana Community AIDS Research Program(LaCARP) CRS
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
New Orleans VAMC CRS
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70146
Country
United States
Facility Name
NIH Clinical Ctr., NIAID HIV Clinic CRS
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814-9692
Country
United States
Facility Name
National Naval Med. Ctr., Infectious Diseases Special Immunology Clinic CRS
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
208995000
Country
United States
Facility Name
Henry Ford Hosp. CRS
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Wayne State Univ. CRS
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
St. John Hosp. & Med. Ctr., Infectious Diseases Dept. CRS
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
William Beaumont Hosp., Infectious Disease Research CRS
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Abbott Northwestern Hosp., Clinic 42 CRS
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Mayo Clinic INSIGHT CRS
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Cooper Univ. Hosp. CRS
City
Camden
State/Province
New Jersey
ZIP/Postal Code
07754
Country
United States
Facility Name
ID Care Inc. - Hillsborough CRS
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
Facility Name
Jersey Shore Univ. Med. Ctr. CRS
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07754
Country
United States
Facility Name
New Jersey Community Research Initiative, Jeffrey Bomser Clinic CRS
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Cathedral Healthcare System, St. Michael's Med. Ctr. CRS
City
Newark
State/Province
New Jersey
Country
United States
Facility Name
St. Joseph's Hosp. & Med. Ctr. of New Jersey CRS
City
Paterson
State/Province
New Jersey
Country
United States
Facility Name
Raritan Bay Med. Ctr., Perth Amboy Division CRS
City
Perth Amboy
State/Province
New Jersey
ZIP/Postal Code
08861
Country
United States
Facility Name
ID Care - Randolph CRS
City
Randolph
State/Province
New Jersey
ZIP/Postal Code
07869
Country
United States
Facility Name
Infectious Disease Specialists of N.J., North Jersey Community Research Initiative CRS
City
Union
State/Province
New Jersey
ZIP/Postal Code
07083
Country
United States
Facility Name
The Early Intervention Program at Kennedy Hosp. CRS
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Jacobi Med. Ctr., Ambulatory Care Pavillion CRS
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Bronx VAMC CRS
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
St. Vincent Hosp. & Med. Ctr. CRS
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Harlem Hospital Ctr./Columbia University CRS (Gordin CTU)
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
Oregon Health & Sciences Univ. Internal Medicine (L-475) CRS
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
Multnomah County Health Dept., HIV Health Services Ctr. CRS
City
Portland
State/Province
Oregon
ZIP/Postal Code
97204
Country
United States
Facility Name
The Research & Education Group-Portland CRS
City
Portland
State/Province
Oregon
ZIP/Postal Code
97209
Country
United States
Facility Name
Providence Portland Med. Ctr., Ambulatory Care and Education Ctr. CRS
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Kaiser Immune Deficiency Clinic of Portland CRS
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Legacy Clinic Emanuel CRS
City
Portland
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
Salem Hosp. CRS
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
Kaiser Permanente Lancaster Clinic CRS
City
Salem
State/Province
Oregon
ZIP/Postal Code
97305
Country
United States
Facility Name
Temple Univ. School of Medicine CRS
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Michael E. DeBakey VAMC CRS
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Northwest Clinic CRS
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Thomas Street Clinic CRS
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Univ. Clinical Research Ctr., Memorial Hermann Hosp. CRS
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Legacy Community Health Services, Inc., Montrose Clinic, Inc.
City
Houston
State/Province
Texas
Country
United States
Facility Name
South Texas Veterans Health Care System, Immunosuppression Clinic CRS
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States
Facility Name
Hanover Med. Park (Mechanicsville, VA) CRS
City
Mechanicsville
State/Province
Virginia
ZIP/Postal Code
23116
Country
United States
Facility Name
Naval Med. Ctr. Portsmouth CRS
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23708
Country
United States
Facility Name
CrossOver Health Ctr. CRS
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23224
Country
United States
Facility Name
South Richmond Health Care Ctr. CRS
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23224
Country
United States
Facility Name
Hunter Holmes McGuire VAMC CRS
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Virginia Commonwealth Univ. Medical Ctr. CRS
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Hosp. de Clinicas Jose de San Martin, Div. Infectologia CRS
City
Ciudad de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
1020
Country
Argentina
Facility Name
Hosp. Italiano de Buenos Aires, Infectious Diseases Section CRS
City
Ciudad de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
1199
Country
Argentina
Facility Name
Hosp. Gen. de Agudos JM Ramos Mejia, Servicio de Inmunocomprometidos CRS
City
Ciudad de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
1221
Country
Argentina
Facility Name
Hospital de Infecciosas F.J. Muniz CRS
City
Ciudad de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
1282
Country
Argentina
Facility Name
Funcei Crs
City
Ciudad de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Hosp. Gen. de Agudos Juan A. Fernandez CRS
City
Ciudad de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Hosp. Gen. de Agudos 'Teodoro Alvarez' CRS
City
Ciudad de Buenos Aires
State/Province
Buenos Aires
Country
Argentina
Facility Name
Hospital Nacional Professor Alejandro Posadas CRS
City
El Palomar
State/Province
Buenos Aires
ZIP/Postal Code
1706
Country
Argentina
Facility Name
Hospital Interzonal de Agudos Oscar Alende, Sala de Infectologia CRS
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
7600
Country
Argentina
Facility Name
Caici Crs
City
Rosario
State/Province
Provincia De Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Hosp. Rawson CRS
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Hosp. Interzonal de Agudos San Juan de Dios CRS
City
La Plata
ZIP/Postal Code
1900
Country
Argentina
Facility Name
Hosp. Central, Immunology Dept. CRS
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
Facility Name
Interchange General Practice CRS
City
Canberra
State/Province
Australian Capital Territory
ZIP/Postal Code
2601
Country
Australia
Facility Name
Canberra Hosp., Canberra Sexual Health Clinic CRS
City
Woden
State/Province
Australian Capital Territory
ZIP/Postal Code
2606
Country
Australia
Facility Name
Burwood Road Gen. Practice CRS
City
Burwood
State/Province
New South Wales
ZIP/Postal Code
2134
Country
Australia
Facility Name
St. Vincent's Hospital CRS
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Taylor Square Private Clinic CRS
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Holdsworth House Gen. Practice CRS
City
Darlinghurst
State/Province
New South Wales
Country
Australia
Facility Name
John Hunter Hosp., Immunology & Infectious Diseases Unit CRS
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
407 Doctors CRS
City
Surry Hills
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Albion Street Ctr. CRS
City
Surry Hills
State/Province
New South Wales
Country
Australia
Facility Name
Queensland Health - AIDS Med. Unit CRS
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Cairns Base Hosp., Sexual Health Services CRS
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4870
Country
Australia
Facility Name
Gladstone Road Medical Ctr. CRS
City
Highgate Hill
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Nambour Gen. Hosp. CRS
City
Nambour
State/Province
Queensland
ZIP/Postal Code
4560
Country
Australia
Facility Name
Royal Adelaide Hosp. CRS
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
The Care & Prevention Programme CRS
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Carlton Clinic CRS
City
Carlton
State/Province
Victoria
Country
Australia
Facility Name
The Alfred Hosp., Clinical Research - Infectious Diseases Unit CRS
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Prahran Market Clinic CRS
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Northcote Clinic CRS
City
Northcote
State/Province
Victoria
ZIP/Postal Code
3070
Country
Australia
Facility Name
Royal Melbourne Hosp., Victorian Infectious Diseases Service CRS
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
The Ctr. Clinic INSIGHT CRS
City
St. Kilda
State/Province
Victoria
Country
Australia
Facility Name
Royal Perth Hospital CRS
City
Perth
State/Province
Western Australia
Country
Australia
Facility Name
Gold Coast Sexual Health Clinic CRS
City
Miami, Queensland
Country
Australia
Facility Name
Univ. of Vienna Med. School, Div. of Allergy, Immunology & Infectious Diseases - Sued B CRS
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
SMZ Baumgartner Hoehe, Immunambulanz Pavillion Wienerwald Parterre CRS
City
Wien
ZIP/Postal Code
A-1140
Country
Austria
Facility Name
Ctr. Hospitalier Universitaire, St Pierre, Div. of Infectious Diseases (PL5) CRS
City
Bruxelles
Country
Belgium
Facility Name
Centro de Referencia e Treinamento em DST/AIDS - Sao Paulo CRS
City
Vila Mariana
State/Province
Sao Paulo
ZIP/Postal Code
04121-000
Country
Brazil
Facility Name
Instituto de Infectologia Emilio Ribas CRS
City
Sao Paulo
ZIP/Postal Code
01246-900
Country
Brazil
Facility Name
Universidade Federal de Sao Paulo,IDIPA-Instituto Paulista de Doencas Infecciosas e Parasitarias CRS
City
Sao Paulo
ZIP/Postal Code
04040-002
Country
Brazil
Facility Name
Univ. of Alberta Hosp., Clinical Research Office CRS
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Cool Aid Community Health Ctr. CRS
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Q.E. II Health Sciences Ctr., Captial District Authority, Victoria Gen. Hosp. CRS
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
McMaster Univ. Med. Ctr. Hamiton Health Sciences, SIS Clinic CRS
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
St. Joseph's Health Ctr. of London, HIV Care Programme CRS
City
London
State/Province
Ontario
ZIP/Postal Code
N5Y 3H6
Country
Canada
Facility Name
Ottawa Hosp., Gen. Campus CRS
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
The HAVEN Program, Sudbury Regional Hosp., Laurentian Site CRS
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Facility Name
Toronto Gen. Hosp. Infectious Diseases CRS
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Windsor Regional Hosp., HIV Care Program CRS
City
Windsor
State/Province
Ontario
Country
Canada
Facility Name
CHUS - Hopital Fleurimont, Centre de Recherche Clinique CRS
City
Fleurimont
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Hopital Maisonneuve-Rosemont, Dept. de Microbiologie CRS
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
CHUM - Campus Notre-Dame CRS
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Royal Victoria Hosp., Montreal Chest Institute CRS
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Quebec - CHUL, Centre de Recherche en Indectiologie CRS
City
Sainte-Foy
State/Province
Quebec
Country
Canada
Facility Name
Royal Univ. Hosp. CRS
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Aalborg Hosp., Dept. of Infectious Diseases CRS
City
Aalborg
Country
Denmark
Facility Name
Skejby Sygehus, Department of Infectious Diseases Q (ambulatoriet) CRS
City
Aarhus
ZIP/Postal Code
DK-8200
Country
Denmark
Facility Name
Rigshospitalet, Department of Infectious Diseases, M5112 CRS
City
Copenhagen
Country
Denmark
Facility Name
Hvidovre Univ. Hosp., Dept. of Infectious Diseases CRS
City
Hvidovre
Country
Denmark
Facility Name
Odense Univ. Hosp., Med. Dept. C CRS
City
Odense
Country
Denmark
Facility Name
Centre Hospitalier de la Region Annecienne, Service des Maladie Infectieuses CRS
City
Cedex
State/Province
Pringy
Country
France
Facility Name
CHRU d'Angers, Service de Maladies Infectieuses CRS
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
Hopital Saint-Jacques, Service des Maladies Infectieuses et Tropicales CRS
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Hopital Avicenne, Service de Medecine B CRS
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
Hopital Antoine Beclere Service d'Immunologie Clinique CRS
City
Clamart
ZIP/Postal Code
92141
Country
France
Facility Name
Hopital Louis Mourier, Service de Medecine Interne CRS
City
Colombes
ZIP/Postal Code
92701
Country
France
Facility Name
Hopital Henri Mondor, Immunopathologie Clinique CRS
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Hopital Raymond Poincare - Vidal 2, Service des Maladies Infectieuses et Tropicales CRS
City
Garches
ZIP/Postal Code
92380
Country
France
Facility Name
Hopital de Bicetre, Service de Medecine Interne CRS
City
Le Kremlin-Bicetre
ZIP/Postal Code
94275
Country
France
Facility Name
Hopital Sainte Marguerite, CISIH Hopital de Jour CRS
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Hopital de la Conception, Service des Maladies Infectieuses CRS
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Hopital Gui de Chauliac, Service des Maladies Infectieuses et Tropicales CRS
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital de l'Archet 1, Service de Medecine Interne 2 Hematologie Clinique CRS
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hopital Saint-Antoine, Service de Maladies Infectieuses CRS
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hopital de La Salpetriere, Service de Medecine Interne CRS
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Hopital Cochin, Service de Medecine Interne 2 CRS
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
Hopital Necker, Service des Maladies Infectieuses CRS
City
Paris
ZIP/Postal Code
75743
Country
France
Facility Name
Hopital Europeen Georges Pompidou, Service d'Immunologie Clinique CRS
City
Paris
ZIP/Postal Code
75908
Country
France
Facility Name
Hopital Tenon, Service de Maladies Infectieuses et Tropicales CRS
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
C.H.U. Bichat - Claude Bernard Service des Maladies Infectieuses et Tropicales CRS
City
Paris
Country
France
Facility Name
CHRU de Strasbourg (France) CRS
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Hopital Foch, Service de Medecine Interne CRS
City
Suresenes
ZIP/Postal Code
92151
Country
France
Facility Name
Univ. Hosp. Charite, Dept of Infectious Diseases CRS
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Ruhr-Univ., Interdiszipl. Immunolog. Ambulanz CRS
City
Bochum
Country
Germany
Facility Name
Medizinische Universitaetsklinik - Bonn, Immunologische Ambulanz CRS
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Ctr. for HIV & Hepatogastroenterology, HIV Specialised Practice (Private Practice) CRS
City
Duesseldorf
ZIP/Postal Code
40237
Country
Germany
Facility Name
Johann Wolfgang Goethe Univ. Hosp., Infektionsambulanz CRS
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
IPM Study Ctr. (Hamburg) CRS
City
Hamburg
Country
Germany
Facility Name
Univ. Hosp. Heidelberg, Dept. of Dermatology CRS
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Klinik I fur Innere Medizin der Universitat zu Koln, Studienburo fur Infektiologie u. HIV CRS
City
Koln
Country
Germany
Facility Name
Klinikum Innenstadt, Infektionsambulanz und Tagesklinik CRS
City
Munchen
Country
Germany
Facility Name
Univ. of Wuerzburg, Medizinische Poliklinik, Schwerpunkt Hepatologie/Infektiologie CRS
City
Wuerzburg
Country
Germany
Facility Name
St. James' Hosp., Guide Clinic CRS
City
Dublin
Country
Ireland
Facility Name
Rambam Med. Ctr., Immunology, Allergy & AIDS Institute, B. Rappaport Faculty of Medicine, Technion
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Kaplan Med. Ctr., Ben Ari Institute of Clinical Immunology CRS
City
Rehovot
Country
Israel
Facility Name
Tel Aviv Sourasky Med. Ctr., Clinical Immunology Unit and AIDS Ctr. CRS
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Civili di Brescia, 1st Division of Infectious Diseases CRS
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Civili di Brescia, Dept of Infectious & Tropical Disease, Hosp.Spedali Civili of Brescia CRS
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Ospedale S. Maria Annunziata, U.O. Malattie Infettive CRS
City
Firenze
ZIP/Postal Code
50011
Country
Italy
Facility Name
Ospedale San Raffaele, Centro San Luigi - Divisione Malattie Infettive CRS
City
Milano
Country
Italy
Facility Name
Univ. of Milan, Ospedale Luigi Sacco, Institute of Infectious and Tropical Diseases CRS
City
Milano
Country
Italy
Facility Name
Universita degli Studi di Modena e Reggio Emilia, Clinica delle Malattie Infettive e Tropicali CRS
City
Modena
Country
Italy
Facility Name
San Matteo Hospital - University of Pavia, Division of Infectious and Tropical Diseases CRS
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Universita La Sapienza, Clinica Universita La Sapienza CRS
City
Roma
ZIP/Postal Code
00185
Country
Italy
Facility Name
Osaka National Hosp. AIDS Ctr., Clinical Research Institute CRS
City
Osaka
Country
Japan
Facility Name
International Med. Ctr. of Japan CRS
City
Tokyo
Country
Japan
Facility Name
Univ. of Tokyo, Research Hosp. of the Institute of Medical Science CRS
City
Tokyo
Country
Japan
Facility Name
Univ. Hosp. Ctr. of the Med. School of Casablanca, Infectious Diseases Unit CRS
City
Casablanca
Country
Morocco
Facility Name
OLVG -- locatie Prinsengracht, Dept. of Internal Medicine II CRS
City
Amsterdam
ZIP/Postal Code
1017 JZ
Country
Netherlands
Facility Name
Academisch Medisch Centrum CRS
City
Amsterdam
ZIP/Postal Code
1150 AZ
Country
Netherlands
Facility Name
Stichting Medisch Centrum Jan van Goyen, Dept. of Internal Medicine CRS
City
Amsterdam
Country
Netherlands
Facility Name
Groningen Univ. Hosp., Department of Internal Medicine CRS
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Kennemer Gasthuis, Lokatie EG CRS
City
Haarlem
Country
Netherlands
Facility Name
St. Elisabeth Ziekenhuis CRS
City
Tilburg
Country
Netherlands
Facility Name
Ulleval Hosp., Dept. of Infectious Diseases CRS
City
Oslo
Country
Norway
Facility Name
Szpital Specjalistyczny, Osrodek Diagnostyki i Terapii AIDS CRS
City
Chorzow
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Pomeranian Academy of Medicine (PAM), Dept. of Infectious Diseases and Hepatology CRS
City
Szczecin
ZIP/Postal Code
71-455
Country
Poland
Facility Name
Wojewodzki Szpital Zakazny CRS
City
Warsaw
ZIP/Postal Code
01-201
Country
Poland
Facility Name
Wroclaw Univ., School of Med., Dept. of Infectious Diseases, Liver Diseases and AIDS CRS
City
Wroclaw
ZIP/Postal Code
51-171
Country
Poland
Facility Name
Hospital de Cascais, HDDI, Departamento Medicina Interna CRS
City
Cascais
ZIP/Postal Code
2775
Country
Portugal
Facility Name
Hosp. de Egas Moniz, Servicio de Infecciologia e Medicina Tropical CRS
City
Lisboa
ZIP/Postal Code
1349-019
Country
Portugal
Facility Name
Hosp. de Santa Maria, Servico de Doencas Infecciosas CRS
City
Lisboa
Country
Portugal
Facility Name
Tan Tock Seng Hosp., Infectious Diseases Research Ctr. CRS
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Hosp. Donostia CRS
City
San Sebastian
State/Province
Guipuzcoa
ZIP/Postal Code
E-20011
Country
Spain
Facility Name
Hosp. Juan Canalejo, Dept. of Internal Medicine CRS
City
A Coruna
Country
Spain
Facility Name
Hosp. Santa Creu i Sant Pau, Servicio de Medicina Interna CRS
City
Barcelona
ZIP/Postal Code
E-08025
Country
Spain
Facility Name
Hosp. Clinico de Barcelona CRS
City
Barcelona
ZIP/Postal Code
E-08036
Country
Spain
Facility Name
Hosp. del Mar, Internal Medicine-Infectious Diseases CRS
City
Barcelona
Country
Spain
Facility Name
Hosp. Universitari Germans Trias i Pujol, HIV Unit and Retrovirology Lab. CRS
City
Barcelona
Country
Spain
Facility Name
Hosp. Universitario Gregorio Maranion, Microbiology & Infectious Diseases Unit CRS
City
Madrid
ZIP/Postal Code
E-28007
Country
Spain
Facility Name
Centro de Investigacion Carlos III, Infectious Diseases Dept. CRS
City
Madrid
ZIP/Postal Code
E-28029
Country
Spain
Facility Name
Hosp. Severo Ochoa, Internal Medicine and Infectious Diseases CRS
City
Madrid
ZIP/Postal Code
E-28911
Country
Spain
Facility Name
Hosp. 12 de Octubre, Pabellon de Medicina Communitaria CRS
City
Madrid
Country
Spain
Facility Name
Hosp. Clinico San Carlos CRS
City
Madrid
Country
Spain
Facility Name
Hosp. la Princesa, Internal Medicine and Infectious Diseases Service CRS
City
Madrid
Country
Spain
Facility Name
Hosp. Ramon y Cajal (Madrid) CRS
City
Madrid
Country
Spain
Facility Name
Hosp. Universitario La Paz CRS
City
Madrid
Country
Spain
Facility Name
Hosp. Universitario Principe de Asturias CRS
City
Madrid
Country
Spain
Facility Name
Hosp. Universitario Morales Meseguer CRS
City
Murcia
Country
Spain
Facility Name
Hosp. Virgen del Rocio, Infectious Diseases Service CRS
City
Sevilla
ZIP/Postal Code
E-41013
Country
Spain
Facility Name
Karolinska Univ. Hosp. Huddinge, Dept. of Infectious Diseases CRS
City
Stockholm
ZIP/Postal Code
SE-141 86
Country
Sweden
Facility Name
Venhalsan, Soder Hosp., Dept. of Infectious Diseases, Karolinska Univ. Hosp. CRS
City
Stockholm
Country
Sweden
Facility Name
Regional Hosp. of Lugano (Sede Civico), Ospedale Civico di Lugano, Infectious Diseases Unit CRS
City
Lugano
State/Province
Ticino
ZIP/Postal Code
CH-6903
Country
Switzerland
Facility Name
Siriraj Hosp., Mahidol Univ. INSIGHT CRS
City
Bangkok
State/Province
Ratchathewi
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Chulalongkorn Univ. Hosp., HIV-NAT Research Collaboration CRS
City
Bangkok
State/Province
Ratchathewi
Country
Thailand
Facility Name
Chiang Rai Regional Hosp. INSIGHT CRS
City
Chiangrai
Country
Thailand
Facility Name
Chonburi Regional Hosp., Dept. of Internal Medicine CRS
City
Chonburi
Country
Thailand
Facility Name
Khon Kaen Univ., Srinagarind Hosp., Div. of Infectious Diseases & Tropical Medicine, Dept. of Medici
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Brighton & Sussex Univ. Hosp. NHS Trust, HIV Research Office CRS
City
Elm Grove
State/Province
Brighton
ZIP/Postal Code
BN2 1ES
Country
United Kingdom
Facility Name
Royal Victoria Hosp. Dept. of Genitourinary Medicine CRS
City
Belfast
State/Province
Northern Ireland
Country
United Kingdom
Facility Name
Churchill Hosp. John Warin Ward CRS
City
Headington
State/Province
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Western Gen. Hosp., Regional Infectious Diseases Unit CRS
City
Edinburgh
State/Province
Scotland
Country
United Kingdom
Facility Name
Gartnaval Gen. Hosp., Brownlee Ctr. CRS
City
Glasgow
State/Province
Scotland
Country
United Kingdom
Facility Name
Heartlands Hosp. Dept. of Infection & Tropical Disease Outpatients CRS
City
Birmingham
ZIP/Postal Code
B9 5ST
Country
United Kingdom
Facility Name
Royal Devon & Exeter NHS Foundation Trust, Heavitree Hosp., Dept. of GU Medicine CRS
City
Exeter
ZIP/Postal Code
EX1 2ED
Country
United Kingdom
Facility Name
Leicester Royal Infirmary, Dept. of Infection & Tropical Medicine CRS
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Royal London Hosp., Ambrose King Ctr. CRS
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
St. Thomas' Hosp., Dept. of GU Medicine CRS
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
St. George's Hosp. Clinical Infection UnitCRS
City
London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom
Facility Name
Chelsea & Westminster Hosp., St. Stephens Ctr. CRS
City
London
Country
United Kingdom
Facility Name
King's College Hosp., Caldecot Ctr. Dept. of Sexual Health CRS
City
London
Country
United Kingdom
Facility Name
Royal Free Hosp., Dept. of Infection & Immunity, Ian Charleson Day Ctr. CRS
City
London
Country
United Kingdom
Facility Name
St. Bartholomew's Hosp., Infection & Immunity Clinical Group CRS
City
London
Country
United Kingdom
Facility Name
St. Mary's Hosp. of London, Imperial College School of Medicine CRS
City
London
Country
United Kingdom
Facility Name
Univ. College London Med. School, Ctr. for Sexual Health & HIV Research CRS
City
London
Country
United Kingdom
Facility Name
Newcastle Gen. Hosp., Dept of Infection & Tropical Medicine CRS
City
Newcastle Upon Tyne
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
Edith Cavell Hosp. Dept. of Sexual Health, Clinic E CRS
City
Peterborough
Country
United Kingdom
Facility Name
Royal Hallamshire Hosp., Dept. of GU Medicine Communicable Diseases Unit CRS
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
10371503
Citation
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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.
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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. doi: 10.1016/s0197-2456(01)00179-9.
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PubMed Identifier
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Citation
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.
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Citation
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.
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Citation
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.
Results Reference
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PubMed Identifier
24870935
Citation
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.
Results Reference
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PubMed Identifier
22911697
Citation
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.
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Citation
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Results Reference
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Links:
URL
http://www.espritstudy.org
Description
Click here for the ESPRIT International IL-2 Study for HIV-infected Persons Web Site

Learn more about this trial

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

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