Dose-ranging, randomized, clinical trial of atazanavir with lamivudine and stavudine in antiretroviral-naive subjects

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dc.contributor.authorMurphy, Robert L
dc.contributor.authorSanne, Ian
dc.contributor.authorCahn, Pedro
dc.contributor.authorPhanuphak, Praphan
dc.contributor.authorPercival, Lisa
dc.contributor.authorKelleher, Thomas
dc.contributor.authorGiordano, Michael
dc.date.accessioned2024-05-23T23:49:32Z
dc.date.available2024-05-23T23:49:32Z
dc.date.issued2003-12-05
dc.descriptionFil: Cahn P. Fundación Huésped, Buenos Aires; Argentinaes_ES
dc.description.abstractObjective: To compare the efficiency and safety of atazanavir and nelfinavir in antiretroviral-naive patients. Design: Randomization to atazanavir 400 mg or 600 mg once daily; nelfinavir 1250 mg twice a day, plus lamivudine and stavudine. Methods: A blinded (to the atazanavir dose), 48-week trial in patients with HIV-1 RNA ≥ 2000 copies/ml, CD4 cell count ≥ 100 × 106cells/l. Primary end-point: change in HIV-1 RNA from baseline at 48 weeks. Secondary end-point: subjects with HIV-1 RNA < 400, and < 50 copies/ml, CD4 cell count changes, adverse events. Results: The 467 randomized subjects had comparable baseline characteristics across treatments. With atazanavir 400 mg, 600 mg and nelfinavir, respectively, mean changes in HIV-1 RNA (log10 copies/ml) from baseline to 48 weeks were −2.51, −2.58, −2.31; HIV-1 RNA < 400 copies/ml [intent-to-treat population (ITT), non-completion = failure (NC = F)], 64%, 67%, 53%; HIV-1 RNA < 50 copies/ml (ITT NC = F), 35%, 36%, 34%; mean CD4 cell count increased comparably at 48 weeks (234 × 106, 243 × 106, 211 × 106cells/l). Adverse events were similar across treatments with the exception of diarrhea (more frequent with nelfinavir) and jaundice (more frequent with atazanavir). Mean changes from baseline to 48 weeks were: fasting low density lipoprotein cholesterol, +5.2%, +7.1% and +23.2% (at 56 weeks) and fasting triglycerides (48 weeks), +7.2%, +7.6% and +49.5%, in the atazanavir 400 mg, 600 mg, and nelfinavir groups, respectively (P < 0.01, atazanavir versus nelfinavir). Conclusions: Atazanavir is a potent, safe, well tolerated, and effective once-daily protease inhibitor with low pill burden (two capsules/day). Lipid changes with atazanavir were significantly less than with nelfinavir, however, clinical significance of these finding in terms of decreased cardiovascular risk is unknown.es_ES
dc.formatapplication/pdfes_ES
dc.identifier.doihttps://doi.org/10.1097/00002030-200312050-00007
dc.identifier.urihttps://repositorio.huesped.org.ar/handle/123456789/1368
dc.languageENGes_ES
dc.provenancePublishedes_ES
dc.relation.ispartofseriesAIDS;17(18):p 2603-2614, December 5, 2003
dc.rightsopenAccesses_ES
dc.subjectClinical Triales_ES
dc.titleDose-ranging, randomized, clinical trial of atazanavir with lamivudine and stavudine in antiretroviral-naive subjectses_ES
dc.typeInforme de investigaciones_ES

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