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

This study has been completed.
Sponsor:
Collaborator:
Chiron Corporation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00004978
First received: March 10, 2000
Last updated: May 1, 2013
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Recombinant interleukin-2 (rIL-2)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • New or Recurrent HIV Disease Progression Event Including Death [ Time Frame: from randomization through study end - median of 7.6 years follow-up ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: from randomization through study end - median of 7.6 years follow-up ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: from randomization through study end - median of 7.6 years follow-up ] [ Designated as safety issue: Yes ]
  • Participants With a New Disease Progression Event or Death [ Time Frame: from randomization through 15 November 2008 - median of 7.6 years follow-up ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: from randomization through study end - median of 7.6 years follow-up ] [ Designated as safety issue: Yes ]
    Average of all available CD4+ cell counts measured at follow-up visits

  • Plasma HIV RNA Levels [ Time Frame: From randomization through study end - median of 7.6 years follow-up ] [ Designated as safety issue: No ]
    log10 HIV-RNA averaged throughout follow-up

  • Number of Participants With Changes in Anti-retroviral Treatment (ART) [ Time Frame: From randomization through study end - median of 7.6 years follow-up ] [ Designated as safety issue: No ]
    Number of participants who changed ART at least once during the study period.

  • Grade 4 Signs and Symptoms [ Time Frame: From randomization through study end - median of 7.6 years follow-up ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: last followup visit - median of 7.6 years follow-up ] [ Designated as safety issue: No ]
    Number of participants using pneumocystis pneumonia (PCP) prophylaxis at the last attended followup visit.

  • Hepatic, Metabolic, and Cardiac Conditions [ Time Frame: From randomization through study end - median of 7.6 years follow-up ] [ Designated as safety issue: Yes ]
    Number of participants experiencing a "serious non-AIDS" event defined as first serious cardiovascular, renal, or hepatic event, or non-AIDS malignancy.


Enrollment: 4150
Study Start Date: March 2000
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rIL-2
Recombinant interleukin-2 (rIL-2) therapy used with combination anti-HIV medication of choice.
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.
Other Names:
  • Proleukin
  • IL-2
  • Aldesleukin
No Intervention: No rIL-2
Control arm uses anti-HIV medication of choice without rIL-2.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004978

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

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00004978     History of Changes
Obsolete Identifiers: NCT00004737
Other Study ID Numbers: ESPRIT 001, 5U01AI046957, 00 I-0071, 3U01AI046957-05S2, 3U01AI046957-05S3, 10118
Study First Received: March 10, 2000
Results First Received: January 20, 2011
Last Updated: May 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Recombinant Proteins
Injections, Subcutaneous
HIV-1
Interleukin-2
Drug Therapy, Combination
CD4 Lymphocyte Count
Disease Progression
Follow-Up Studies
Anti-HIV Agents

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 19, 2014