TY - JOUR
T1 - Evaluation of safety and efficacy of 3tc (lamivudine) in patients with asymptomatic or mildly symptomatic human immunodeficiency virus infection
T2 - A phase i/ii study
AU - Van Leeuwen, Remko
AU - Katlama, Christine
AU - Kitchen, Valerie
AU - Boucher, Charles A.B.
AU - Tubiana, Roland
AU - Mc Bride, Michael
AU - Ingrand, Didier
AU - Weber, Jonathan
AU - Hill, Andrew
AU - Mc Dade, Hugh
AU - Danner, Sven A.
PY - 1995/5
Y1 - 1995/5
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=0028948198&partnerID=8YFLogxK
U2 - 10.1093/infdis/171.5.1166
DO - 10.1093/infdis/171.5.1166
M3 - Article
C2 - 7751691
AN - SCOPUS:0028948198
VL - 171
SP - 1166
EP - 1171
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
SN - 0022-1899
IS - 5
ER -