Evaluation of safety and efficacy of 3tc (lamivudine) in patients with asymptomatic or mildly symptomatic human immunodeficiency virus infection
| Autor: | Valerie Kitchen, Hugh McDade, Remko van Leeuwen, Andrew M. Hill, Roland Tubiana, Didier Ingrand, Sven A. Danner, Jonathan Weber, Michael McBride, Charles A. Boucher, Christine Katlama |
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| Přispěvatelé: | Internal medicine |
| Jazyk: | angličtina |
| Rok vydání: | 1995 |
| Předmět: |
Adult
Male medicine.medical_specialty Abdominal pain Nausea medicine.medical_treatment HIV Core Protein p24 HIV Infections Antiviral Agents Neopterin Gastroenterology Asymptomatic chemistry.chemical_compound Immunopathology Internal medicine Humans Immunology and Allergy Medicine Chemotherapy Dose-Response Relationship Drug Zalcitabine business.industry Surrogate endpoint Lamivudine Middle Aged Biopterin CD4 Lymphocyte Count Infectious Diseases chemistry Immunology Disease Progression medicine.symptom beta 2-Microglobulin business Biomarkers medicine.drug |
| Zdroj: | Journal of Infectious Diseases, 171(5), 1166-1171. Oxford University Press Van Leeuwen, R, Katlama, C, Kitchen, V, Boucher, C A B, Tubiana, R, Mc Bride, M, Ingrand, D, Weber, J, Hill, A, Mc Dade, H & Danner, S A 1995, ' Evaluation of safety and efficacy of 3tc (lamivudine) in patients with asymptomatic or mildly symptomatic human immunodeficiency virus infection : A phase i/ii study ', Journal of Infectious Diseases, vol. 171, no. 5, pp. 1166-1171 . https://doi.org/10.1093/infdis/171.5.1166 |
| ISSN: | 0022-1899 |
| DOI: | 10.1093/infdis/171.5.1166 |
| Popis: | In a phase 1/11 study, 7 levelsof3TC therapy (from 0.5 to 20.0 mg/kg/day) were studied in 104 asymptomatic and mildly symptomatic human immunodeficiency virus-infected patients with CD4 cell counts Ȧ4400 × 106/L. Mild and transient episodes of diarrhea, headache, fatigue, nausea, and abdominal pain were the most frequent events reported. No dose-limiting toxicities were observed. Small and transient increases in CD4 cell counts were detected during the first 4 weeks of treatment. These were followed by progressive declines during prolonged therapy. Sustained decreases in 2-microglobulin, neopterin, and p24 antigen levels were seen over the 52-week study. There was no consistent dose-response correlation for any surrogate marker. Penetration of 3TC into cerebrospinal fluid (CSF) was in the same range as reported for ddC and ddl; the mean CSF-to-serum ratio was 0.06. These findings indicate that 3TC exhibits an excellent safety profile and has antiretroviral activity at the dosages studied. |
| Databáze: | OpenAIRE |
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