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An International Study to Evaluate Anti-HIV Therapy Plus Interleukin-2 (rIL-2) in HIV-Positive Patients Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on An International Study to Evaluate Anti-HIV Therapy Plus Interleukin-2 (rIL-2) in HIV-Positive Patients conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. An International Study to Evaluate Anti-HIV Therapy Plus Interleukin-2 (rIL-2) in HIV-Positive Patients Clinical research trials and An International Study to Evaluate Anti-HIV Therapy Plus Interleukin-2 (rIL-2) in HIV-Positive Patients health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like An International Study to Evaluate Anti-HIV Therapy Plus Interleukin-2 (rIL-2) in HIV-Positive Patients. An International Study to Evaluate Anti-HIV Therapy Plus Interleukin-2 (rIL-2) in HIV-Positive Patients Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a An International Study to Evaluate Anti-HIV Therapy Plus Interleukin-2 (rIL-2) in HIV-Positive Patients clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their An International Study to Evaluate Anti-HIV Therapy Plus Interleukin-2 (rIL-2) in HIV-Positive Patients condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > An International Study to Evaluate Anti-HIV Therapy Plus Interleukin-2 (rIL-2) in HIV-Positive Patients  An International Study to Evaluate Anti-HIV Therapy Plus Interleukin-2 (rIL-2) in HIV-Positive Patients
An International Study to Evaluate Anti-HIV Therapy Plus Interleukin-2 (rIL-2) in HIV-Positive Patients
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to see if it is effective to give HIV-positive patients interleukin-2 (rIL-2) in addition to anti-HIV therapy. Patients will be followed over a period of 5 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 rIL-2 plus anti-HIV therapy will help improve their immune systems and keep them healthier over a longer period of time. IL-2 is a protein found naturally in the blood that helps boost the immune system.
Details: 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/mm3, 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 IL-2 could represent a significant additional treatment strategy. It also has been speculated recently that IL-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 SC rIL-2 therapy or no SC rIL-2 therapy. All patients must receive combination antiretroviral treatment, with the choice of therapy at the discretion of the treating clinician. However, 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/mm3 or above for as long as possible. Patients in the no SC 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 an average of 5 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:
Study Type: Interventional, Treatment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are 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 Patients will not be eligible for this study if they: - 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 breast-feeding.
Total Enrollment: 4000
Location and Contact Information:
Overall Study Official:
DonaldAbrams, Study Chair,
AIDS Research Alliance - Chicago *Recruiting*
Chicago, Illinois, 60657
United States
Recruiting Rita Verheggen 773-244-5800
Ospedale Luigi Sacco Cargnel *Recruiting*
Milano, ,
Italy
Recruiting Antonella Monforte 39 02 356 7031
International Med Ctr of Japan *Recruiting*
Tokyo, ,
Japan
Recruiting Helen Fraser 81352735418
Hopital Bichat - Claude Bernard *Recruiting*
Paris, ,
France
Recruiting Sylvie Legac 33140258080
Kaplan Med Ctr *Recruiting*
Rehovot, ,
Israel
Recruiting Annat Pilpoul 97289441486
Hosp De Santa Maria *Recruiting*
Lisboa, ,
Portugal
Recruiting Francisco Antunes 351 21 793 8043
Burwood Street General Practice *Recruiting*
Burwood, ,
Australia
Recruiting Nicholas Doong 61297452755
Hosp de la Princesa *Recruiting*
Madrid, ,
Spain
Recruiting Ignacio Gil 34915202236
Houston Veterans Administration Med Ctr *Recruiting*
Houston, Texas, 77030
United States
Recruiting Katharine Breaux 713-794-7943
Centre Clinic *Recruiting*
St Kilda, ,
Australia
Recruiting Nicholas Medland 61395255866
St Elisabeth Zeikenhuis *Recruiting*
Tilburg, ,
Netherlands
Recruiting M Sekkat 31 13 5391313
CHU Saint Pierre *Recruiting*
Brussels, ,
Belgium
Recruiting Elizabeth O'Doherty 003225354374
Washington DC VA Medical Center *No longer recruiting*
Washington D.C., District of Columbia, 20422
United States
No longer recruiting
Albion Street Clinic *Recruiting*
Surry Hills, ,
Australia
Recruiting S Jeganathan 61293321090
Hosp del Mar *Recruiting*
Barcelona, ,
Spain
Recruiting Alicia Gonzalez 34932211010
Holdsworth House General Practice *Recruiting*
Darlinghurst, ,
Australia
Recruiting Anthony Frater 61293317228
Rigohospitalet / Dept of Infectious Diseases *Recruiting*
Copenhagen, ,
Denmark
Recruiting Lone Jensen 453-545-7752
Aalborg Hosp South *Recruiting*
Aalborg, ,
Denmark
Recruiting Carsten Larsen 459-932-3205
Ospedale S Raffaele *Recruiting*
Milano, ,
Italy
Recruiting Giuseppe Tambussi 390226437945
George Washington Univ Med Ctr *Recruiting*
Washington D.C., District of Columbia, 20037
United States
Recruiting Sarah Granger 202-741-2442
Univ of Wuerzburg *Recruiting*
Wuerzburg, ,
Germany
Recruiting Thomas Vaeth 499312013174
St Bartholomews Hosp *Recruiting*
London, ,
United Kingdom
Recruiting Des Maitland 02073777457
Bourke Street Clinic *Recruiting*
Surry Hills, ,
Australia
Recruiting Robyn Vale 61293322531
Gold Coast Sexual Health Clinic *Recruiting*
Miami, ,
Australia
Recruiting John Chuah 61 7 5576 9033
Hosp Univ Germans Trias i Pujol *Recruiting*
Barcelona, ,
Spain
Recruiting Antoni Pastor 34934657897
VA Chicago Health Care System - West Side Div *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Mary Werhane 312-666-6500
Hosp Saint-Louis *No longer recruiting*
Paris Cedex IO, ,
France
No longer recruiting
Chiangrai Reg Hosp *Recruiting*
Chiangrai, ,
Thailand
Recruiting Vithaya Pongsurachet
Hosp Univ San Carlos *Recruiting*
Madrid, ,
Spain
Recruiting Maria Molina 34913303538
Hosp Universitario Morales Meseguer *Recruiting*
Murcia, ,
Spain
Recruiting Rose Garrido 34968360900
Univ Hosp Infectious Disease Clinic *Recruiting*
Denver, Colorado, 80204-4507
United States
Recruiting Jack Rouff 303-436-7184
Ruhr Univ, Bochum *Recruiting*
Bochum, ,
Germany
Recruiting Alexander Kreuter 9234 5093473
West Los Angeles VAMC *Recruiting*
Los Angeles, California, 90073
United States
Recruiting Barbara Rossman 310-478-3711
Stichting Medisch Centrum Jan van Goyen *Recruiting*
Amsterdam, ,
Netherlands
Recruiting Peggy Leeuwen 31 20 3055825
Univ of Tokyo Institute of Medical Science *Recruiting*
Tokyo, ,
Japan
Recruiting Tetsuya Nakamura 81354495338
Carlton Clinic *Recruiting*
Carlton, ,
Australia
Recruiting Jonathan Anderson 61393479422
Hosp De Mostoles *No longer recruiting*
Madrid, ,
Spain
No longer recruiting
Mayo Clinic *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Cheryl Shoden 507-255-7766
Klinikum Der Johann Wolfgang Goethe Universitat *Recruiting*
Frankfurt, ,
Germany
Recruiting Claudia Wengenroth 496963017680
McMaster Univ Med Centre *Recruiting*
Hamilton, Ontario,
Canada
Recruiting Sherie Savoy 905-521-2100
King's College Hosp *Recruiting*
Cambewell, ,
United Kingdom
Recruiting Dorrett Graham 02073463479
Haven Program, Laurentian Hosp *Recruiting*
Sudburg, ,
Germany
Recruiting Judy Latendre-Paquette 705-523-7059
William Beaumont Hosp *Recruiting*
Royal Oak, Michigan, 48073
United States
Recruiting Julie Ventimiglio 248-551-4340
Hosp Juan Ramon Jimenez *No longer recruiting*
Huelva, ,
Spain
No longer recruiting
South Texas Veterans Health Care System *Recruiting*
San Antonio, Texas, 78284
United States
Recruiting Kimberly Summers 210-949-3076
General Infirmary at Leeds *Recruiting*
Leeds, ,
United Kingdom
Recruiting Gerald Booth 01133926762
Victoria Gen Hosp, QE II Health Sciences *Recruiting*
Halifax, ,
Canada
Recruiting Heather Haldane 902 473 7431
Windsor Regional Hosp *Recruiting*
Windsor, Ontario,
Canada
Recruiting Nancy McFarland 519-254-6115
Montreal Chest Institute *Recruiting*
Montreal, Quebec,
Canada
Recruiting Sabrina Mastroprimiano 514-849-5201
Universita degli Studi di Modena e Reggio Emilia *Recruiting*
Modena, ,
Italy
Recruiting Giovanni Guaraldi 39 059 422 799
Montrose Clinic *Recruiting*
Houston, Texas, 77006
United States
Recruiting Brian Bell 713-830-3011
Hvidovre Univ Hosp *Recruiting*
Hvidore, ,
Denmark
Recruiting Astrid Dilling-Hansen 453-632-3021
Queensland Health - AIDS Med Unit *Recruiting*
Brisbane, ,
Australia
Recruiting Hugo Ree 61732245526
Osaka National Hosp *Recruiting*
Osaka, ,
Japan
Recruiting Sachiko Oda 81669421331
Royal Perth Hosp *Recruiting*
Perth, ,
Australia
Recruiting Jenny Skett 61892243429
Western Gen Hosp *Recruiting*
Edinburgh, ,
United Kingdom
Recruiting Sheila Morris 01315372842
Klinik I fir Innere Medizin der Univ zu Koln *Recruiting*
Koln, ,
Germany
Recruiting Ellen Rund 492214785860
Hosp Nuestra Sra De Aranzazu *Recruiting*
Guipuzcoa, ,
Spain
Recruiting Francisco Arrondo 34943007000
Whitman Walker Clinic *Recruiting*
Washington D.C., District of Columbia, 20009
United States
Recruiting David Dasso 202-745-6150
Ulleval Hosp *Recruiting*
Oslo, ,
Norway
Recruiting Astrid Rudi 472-211-9112
Saint Mary's Hosp *No longer recruiting*
London, ,
United Kingdom
No longer recruiting
Natl Naval Med Ctr *Recruiting*
Bethesda, Maryland, 208995000
United States
Recruiting Jean Vita 301-295-6400
Hosp Central de Asturias *Recruiting*
Asturias, ,
Spain
Recruiting Jose Maradona
Prahran Market Clinic *Recruiting*
South Yarra, ,
Australia
Recruiting Jeni Mitchell 61398264500
Marselisborg Hosp *Recruiting*
Aarus C, ,
Denmark
Recruiting Niels Obel 458-949-1802
Univ TX Health Science Ctr *Recruiting*
Houston, Texas, 77030
United States
Recruiting Hilda Cuervo 713-500-6751
Marilyn McMurchie, MD *Recruiting*
Darlinghurst, ,
Australia
Recruiting Marilyn McMurchie 61293317953
Warren G Magnuson Clinical Ctr *Recruiting*
Bethesda, Maryland, 208924754
United States
Recruiting Patient Recruitment 800-411-1222
Royal Sussex County Hosp *Recruiting*
Brighton, ,
United Kingdom
Recruiting Nicky Perry 01273664532
Chelsea and Westminster Hosp *Recruiting*
London, ,
United Kingdom
Recruiting Ann Sullivan 02088466132
Research & Education Group *Recruiting*
Portland, Oregon, 97209
United States
Recruiting Norma Martinez 503-229-8428
Hosp Gen de Agudos Juan A Fernandez *Recruiting*
Buenos Aires, ,
Argentina
Recruiting Carlos Zala 541148082627
Univ Hosp Ctr of the Med School *Recruiting*
Casablanca, ,
Morocco
Recruiting Kamal El Filali 212 22 22 78 31
Hosp Carlos III *Recruiting*
Madrid, ,
Spain
Recruiting Luz Carbonero 34914532500
Hosp Doce De Octubre *Recruiting*
Madrid, ,
Spain
Recruiting Frederico Pulido 34913908028
Hosp Ramon y Cajal *Recruiting*
Madris, ,
Spain
Recruiting Ana Moreno 34913368238
Univ College London Med School *Recruiting*
London, ,
United Kingdom
Recruiting Diana Aldam 02073809810
Miami Veterans Administration Med Ctr *Recruiting*
Miami, Florida, 33125
United States
Recruiting Mack Smith 305-324-3267
Toronto Gen Hosp *Recruiting*
Toronto, Ontario,
Canada
Recruiting Margaret McGrath-Chong 416-340-3871
Chulalongkorn Univ Hosp *Recruiting*
Pathumwan, ,
Thailand
Recruiting Chris Ducombe 66225573345
Abbott-Northwestern Hosp / Clinic 42 *Recruiting*
Minneapolis, Minnesota, 55404
United States
Recruiting Joann Armstrong 612-863-5241
Odense Univ Hosp *Recruiting*
Unknown, ,
Denmark
Recruiting Court Pedersen 004565411816
Hosp La Paz *Recruiting*
Madrid, ,
Spain
Recruiting Alicia Hernandez 34917277099
Royal Victoria Hosp *Recruiting*
Belfast, ,
Ireland
Recruiting Sinead McKernan 02890894733
Gartnaval Gen Hosp *Recruiting*
Glasgow, ,
United Kingdom
Recruiting Sheila Evans 01412111093
Peterborough District Hosp *Recruiting*
Cambridgeshire, ,
United Kingdom
Recruiting Adrian Palfreeman 01733874216
Royal Free Hosp *Recruiting*
London, ,
United Kingdom
Recruiting Deborah Wilson 02074726232
Klinikum Innenstadt *Recruiting*
Munchen, ,
Germany
Recruiting Carola Ludwig 49 89 5160 3741
Atlanta VA Med Ctr *Recruiting*
Decatur, Georgia, 30033
United States
Recruiting Susan Wirtz 404-321-6111
Centre Hosp de la Region Annecienne *Recruiting*
ANNECY Cedex, ,
France
Recruiting Maryse Bensalem 33450883068
Infectious Disease Specialists of NJ *Recruiting*
Union, New Jersey, 07083
United States
Recruiting Philip Andrew 908-810-9200
Univ of Alberta/Division of Inf Dis/Dept of Med *Recruiting*
Edmonton, Alberta,
Canada
Recruiting Laura Mashinter 780 407 1236
Univ de Sherbrooke / Ctr de Recherche Clinique *Recruiting*
Fleurimont, Quebec,
Canada
Recruiting Mimose Dambreville 819-829-3230
Hosp Juan Canalejo *Recruiting*
A Coruna, ,
Spain
Recruiting Javier Puig 34981178189
Venhalsan Soder Hosp *Recruiting*
Stockholm, ,
Sweden
Recruiting Viveca Holmberg 468-616-3476
Chonburi Reg Hosp *Recruiting*
Chonburi, ,
Thailand
Recruiting Chureeratana Bowaonwatanuwang 661-344-6180
Centre Hospitalier Universitaire de Quebec *Recruiting*
Ste Foy, Quebec,
Canada
Recruiting Lyne Lapointe 418-656-4141
Kennemer Gasthuis, Lokatie EG *Recruiting*
AK Harlem, ,
Netherlands
Recruiting M Shoemaker 31 23 5522169
North Manchester Gen Hosp *No longer recruiting*
Manchester, ,
United Kingdom
No longer recruiting
Additional Information:
Study ID Numbers: ESPRIT 001; 00 I-0071
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004978
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An International Study to Evaluate Anti-HIV Therapy Plus Interleukin-2 (rIL-2) in HIV-Positive Patients
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