| Titre : | Nucleoside analogs plus ritonavir in stable antiretroviral therapy-experienced HIV-infected Children a randomized controlled trial. (2000) |
| Auteurs : | S.A. NACHMAN ; W. BORKOWSKY ; S. FISCUS ; E. JIMENEZ ; S. LEE ; K. MCINTOSH ; L. MOFENSON ; S. PELTON ; J. PITT ; M. RATHORE ; M.E. Smith ; K. STANLEY ; B. WELLS ; A. WIZNIA ; R. YOGEV ; Center for Biostatistics in Aids Research. School of Public Health. Harvard University. USA ; Pediatric Aids Clinical Trials Group 338 Study Team. INC |
| Type de document : | Article |
| Dans : | JAMA - Journal of the american medical association (vol. 283, n° 4, 2000) |
| Pagination : | 492-498 |
| Langues: | Anglais |
| Mots-clés : | Sida ; Virose ; Infection ; VIH ; Rétrovirus ; Virus ; Evaluation ; Sécurité ; Tolérance ; Enfant ; Homme ; Immunopathologie ; Enzyme ; Médicament antiviral |
| Résumé : | [BDSP. Notice produite par INIST fUV9GR0x. Diffusion soumise à autorisation]. Context Although protease inhibitors are used routinely in adults with human immunodeficiency virus (HIV) infection, the role of these drugs in the treatment of clinically stable HIV-infected children is not clear. Objective To evaluate the safety, tolerance, and virologic response produced by a change in antiretroviral therapy in HIV-infected children who were clinically and immunologically stable while receiving previous therapy. Design The Pediatric AIDS Clinical Trials Group 338, a multicenter, phase 2, randomized, open-label controlled trial conducted from February 6 to April 30,1997 (patient entry period) ; patients were followed up for 48 weeks. Setting Pediatric HIV research clinics in the United States and Puerto Rico. Patients Two hundred ninety-seven antiretroviral-experienced, protease inhibitor-naive, clinically stable HIV-infected children aged 2 to 17 years. Interventions Children were randomized to receive zidovudine, 160 mg/m2 3 times per day, plus lamivudine, 4 mg/kg 2 times per day (n=100) ; the same regimen plus ritonavir, 350 mg/m2 2 times per day (n=100) ; or ritonavir, 350 mg/m2 2 times per day, and stavudine, 4 mg/kg 2 times per day (n=97). Main Outcome Measure Plasma HIV-1 RNA levels at study weeks 12 and 48, compared among the 3 treatment groups. (...) |
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