Comparison of subcutaneous and intravenous interleukin-2 in asymptomatic HIV-1 infection: a randomised controlled trial
| Autor: | Jean-François Delfraissy, Claire Rabian, Yves Levy, E Gomard, Jean-Pierre Aboulker, JG Guillet, L Boumsell, Cécile Goujard, J. A. Gastaut, I Carriere, S Houhou, Jean-Paul Viard, Maxime Seligmann, L Weiss, Eric Oksenhendler, Catherine Capitant |
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| Rok vydání: | 1999 |
| Předmět: |
Interleukin 2
Chemotherapy medicine.medical_specialty business.industry medicine.medical_treatment General Medicine Gastroenterology Asymptomatic law.invention Surgery Zidovudine Regimen Randomized controlled trial Intravenous therapy law Internal medicine medicine medicine.symptom business Didanosine medicine.drug |
| Zdroj: | The Lancet. 353:1923-1929 |
| ISSN: | 0140-6736 |
| Popis: | Summary Background Intermittent interleukin-2 therapy for HIV-1 by continuous intravenous infusion leads to sustained increase of CD4 T cells. This method of administration is, however, inconvenient and has limiting toxic effects. We did a randomised study to compare safety and efficacy of antiviral treatment alone or combined with various interleukin-2 regimens in HIV-1-infected patients. Methods 94 symptom-free patients, naive to antiretroviral treatment, with CD4-T-cell counts of 250–550 cells/μL at baseline were randomly assigned zidovudine and didanosine alone (n=26) or combined with interleukin-2 administered intravenously (12 million IU/day, n=22) or subcutaneously (3 million IU/m 2 twice daily, n=24) for 5 days, or were given polyethylene-glycol-modified (PEG) interleukin-2 (2 million IU/m 2 intravenous bolus, n=22) administered every 2 months from week 2 to week 50 (seven cycles). Safety and immunological and virological results were monitored until week 56. Findings CD4-T-cell count increased to higher than baseline by a mean of 564 cells/μL (subcutaneous group), 676 cells/μL (intravenous group), 105 cells/μL (PEG group), and 55 cells/μL (antiretroviral-therapy group, p=0·0001). 68% and 77% of patients in the subcutaneous and intravenous groups, respectively, achieved an 80% increase of CD4 T cells (p Interpretation Subcutaneous interleukin-2 is a convenient regimen that, as well as intravenous therapy, improves immunological function in HIV-1-infected patients receiving two nucleosides. Larger studies are needed to show whether immunological improvements translate into clinical benefit. |
| Databáze: | OpenAIRE |
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