| Interleukin-2 before antiretroviral therapy in patients with HIV infection: a randomized trial (ANRS 119). | |
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MedLine Citation:
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PMID: 19508157 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Interleukin (IL)-2 increases CD4 T cell counts when combined with antiretroviral therapy (ART). Whether IL-2 alone can increase CD4 cell counts is unknown. METHODS: A total of 130 adults who had a CD4 cell count of 300-500 cells/microL (and, thus, were not eligible to receive ART) were randomized to receive either intermittent IL-2 therapy or no treatment. The primary end point was a drop in CD4 cell count to <300 cells/microL, initiation of ART, the occurrence of an AIDS-defining event, or death. RESULTS: Through week 96, 35% of the patients in the IL-2 arm and 59% in the control arm reached the primary end point (P = .008). Median changes from baseline in the IL-2 and control arms were +51 and -64 cells/microL, respectively, for CD4 cell count (P < .001) and were +0.02 and +0.04 log(10) copies/mL, respectively, for plasma viral load (P = .93). Among patients with a baseline viral load <4.5 log(10) copies/mL, 64% in the IL-2 arm and 10% in the control arm did not reach the primary end point through week 150 (P < .001), and the time to ART initiation was deferred by 92 weeks in the IL-2 arm. The incidences of an AIDS-defining event, death, and grade 3 or 4 adverse events were similar between study arms. CONCLUSION: IL-2 increased CD4 cell counts without affecting HIV replication and allowed the initiation of ART to be deferred. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00120185 . |
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Authors:
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Jean-Michel Molina; Yves Levy; Isabelle Fournier; Stephanie Hamonic; Michèle Bentata; Genevieve Beck-Wirth; Marie-Lise Gougeon; Alain Venet; Isabelle Madelaine; Daniel Sereni; François Jeanblanc; Thomas Boulet; François Simon; Jean-Pierre Aboulker; |
Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: The Journal of infectious diseases Volume: 200 ISSN: 0022-1899 ISO Abbreviation: J. Infect. Dis. Publication Date: 2009 Jul |
Date Detail:
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Created Date: 2009-07-09 Completed Date: 2009-08-21 Revised Date: 2009-09-14 |
Medline Journal Info:
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Nlm Unique ID: 0413675 Medline TA: J Infect Dis Country: United States |
Other Details:
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Languages: eng Pagination: 206-15 Citation Subset: AIM; IM |
Affiliation:
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Assistance Publique-Hôpitaux de Paris, Hôpital Saint-Louis, France. jean-michel.molina@sls.aphp.fr |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00120185 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Anti-HIV Agents / administration & dosage, adverse effects, therapeutic use* CD4 Lymphocyte Count Drug Administration Schedule Female HIV / drug effects HIV Infections / drug therapy* Humans Interleukin-2 / administration & dosage, adverse effects, therapeutic use* Male Middle Aged Virus Replication / drug effects Young Adult |
| Chemical | |
Reg. No./Substance:
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0/Anti-HIV Agents; 0/Interleukin-2 |
| Investigator | |
Investigator/Affiliation:
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J -M Molina / ; Y Levy / ; I Fournier / ; J P Aboukler / ; S Hamonic / ; F Simon / ; F Agbalika / ; P Palmer / ; Y Levy / ; J P Aboulker / ; J M Molina / ; G Beck-Wirth / ; F Simon / ; A Venet / ; M L Goujeon / ; I Fournier / ; S Hamonic / ; L Cotte / ; I Madelaine / ; C Picketty / ; M Seligmann / ; L Morand Joubert / ; J L Vilde / ; A Laplanche / ; Lagarde / ; David / ; Costa / ; Kinoo / ; Bentata / ; Alloui / ; Baazia / ; Brianne / ; Soreda / ; Bouchaud / ; Laurent / ; Coquet / ; Drobacheff / ; Bettinger / ; Essert / ; Clauvel / ; Oksenhendler / ; Gerard / ; Martinie / ; Mezreb / ; Sereni / ; Lascoux-Combe / ; Pintado / ; Prevoteau de Clary / ; Taulera / ; Molina / ; Balkan / ; Bani-Sadr / ; Colin de Verdiere / ; Fournier / ; Garrait / ; Hocqueloux / ; Kouchner / ; Loze / ; Ponscgroupe / ; Schnell / ; Tourneur / ; Palmer / ; Madelaine / ; Dupont / ; Viard / ; Lahoulou / ; Broissand / ; Bru / ; Gaillat / ; Bensalem / ; Charvier / ; Michon / ; Walter / ; Chanzy / ; Dervieux / ; Delfraissy / ; Goujard / ; Nguyen Wartel / ; Quertainmont / ; Rousseau / ; Segeral / ; Idri / ; Bocquentin / ; N'Guessan / ; Môle / ; Duracinsky / ; Sellier / ; Rami / ; Parrinello / ; Jeantils / ; Tassi / ; Pialoux / ; Rozenbaum / ; Baakili / ; Slama / ; Chakvetadze / ; Lukiana / ; Zatla / ; Weiss / ; Aouba / ; Haddadi / ; Vinceneux / ; Bloch / ; Gaba / ; Sobel / ; Lascaux / ; Lelièvre / ; Levy / ; Chesnel / ; Bricaire / ; Katlama / ; Gohsn / ; Amellal / ; Fievet / ; Herson / ; Bonmarchand / ; Simon-Coutellier / ; Calvez / ; Kouadio / ; Girard / ; Bollens / ; Morand-Joubert / ; Daguenel-Nguyen / ; Lefèbvre / ; Ouazene / ; Lagneau / ; Morlat / ; Beylot / ; Garrigue / ; Pedeboscq / ; Louis / ; Pertusa / ; Touraine / ; Brunel / ; Chiarello / ; Jeanblanc / ; Jourdain / ; Livrozet / ; Makhloufi / ; Tardy / ; Nageotte / ; Trepo / ; Bailly / ; Benmakhlouf / ; Cotte / ; Miailhes / ; Radenne / ; Ritter / ; André / ; Trabaud / ; Gastaut / ; Drogoul / ; Fabre / ; Frixon-Marin / ; Poizot-Martin / ; Tamalet / ; Fournier / ; Gaudebout / ; Yeni / ; Gerbe / ; Phung / ; Raffi / ; Allavena / ; Billaud / ; Bonnet / ; Brunet-François / ; Huart / ; Milpied / ; Reliquet / ; Sicot / ; Poirier / ; Lepelletier / ; Boutoille / ; Perre / ; Aubry / ; Suaud / ; Esnaut / ; Leautez / ; Arvieux / ; Viet-Peaucelle / ; Beytout / ; Jacomet / ; Henquell / ; Coudert / ; Gallais / ; Marangone / ; Stein / ; Beck-Wirth / ; Beck / ; Benomar / |
| Comments/Corrections | |
Comment In:
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J Infect Dis. 2009 Jul 15;200(2):164-5
[PMID:
19508158
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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