A Phase I/II Study of 2'-Deoxy-3'-Thiacytidine (Lamivudine) in Patients with Advanced Human Immunodeficiency Virus Infection
| Autor: | Catherine A. Vicary, Steven N. Warthan, James M. Pluda, John Ruedy, Timothy P. Cooley, Nancy E. Reinhalter, Julio S. G. Montaner, Robert Yarchoan, Mark A. Wainberg, Joseph B. Quinn, Laura E. Shay, Hilary M. Hirst, Marc Rubin, Geoffrey J. Yuen |
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| Rok vydání: | 1995 |
| Předmět: |
Adult
Male medicine.medical_specialty Time Factors Combination therapy medicine.medical_treatment HIV Core Protein p24 HIV Infections Gastroenterology Pharmacokinetics Internal medicine Immunopathology medicine Humans Immunology and Allergy Sida Acquired Immunodeficiency Syndrome Chemotherapy biology Zalcitabine business.industry Lamivudine Middle Aged biology.organism_classification Clinical trial Infectious Diseases Immunology Toxicity Female beta 2-Microglobulin business medicine.drug |
| Zdroj: | Journal of Infectious Diseases. 171:1438-1447 |
| ISSN: | 1537-6613 0022-1899 |
| DOI: | 10.1093/infdis/171.6.1438 |
| Popis: | In a phase I/II trial assessing the toxicity, pharmacokinetics, and activity of the (-)enantiomer of 2'-deoxy-3'-thiacytidine (3TC, lamivudine), 97 patients with AIDS or advanced human immunodeficiency virus (HIV) disease were administered 3TC at 0.5-20.0 mg/kg/day. The cohort's median entry CD4 cell count was 128/mm3 (range, 7-357). A toxic dose was not reached, although some patients reported mild headache, insomnia, and abdominal symptoms, and there was a general downward trend in neutrophil counts at the highest doses. Although subjective and difficult to interpret, increases in energy and appetite were noted, particularly in patients receiving > or = 8.0 mg/kg/day. Immunologic and virologic parameters showed evidence of at least transient anti-HIV activity at those higher doses. Although further studies of 3TC as monotherapy are needed, its favorable toxicity profile, evidence of at least transient clinical activity, and results of in vitro resistance experiments support further clinical testing in combination therapy. |
| Databáze: | OpenAIRE |
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