Linked Life Data

8726029

Source:http://linkedlifedata.com/resource/pubmed/id/8726029

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
6
pubmed:dateCreated
1997-1-29
pubmed:abstractText
The purpose of this study was to determine the safety and pharmacokinetics of lamivudine (3TC), a nucleoside analog that has shown potent in vitro and recent in vivo activity against human immunodeficiency virus. Sixteen human immunodeficiency virus-infected patients, six with normal renal function (creatinine clearance [CLCR], > or = 60 ml/min), four with moderate renal impairment (CLCR, 10 to 40 ml/min), and six with severe renal impairment (CLCR, < 10 ml/min), were enrolled in the study. After an overnight fast, patients were administered 300 mg of 3TC orally. Blood was obtained before 3TC administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 32, 40, and 48 h afterward. Timed urine collections were performed for patients able to produce urine. Serum and urine were assayed for 3TC by reverse-phase high-performance liquid chromatography with UV detection. Pharmacokinetic parameters were calculated by using standard noncompartmental techniques. The peak concentration of 3TC increased with decreasing renal function; geometric means were 2,524, 3,538, and 5,684 ng/ml for patients with normal renal function, moderate renal impairment, and severe renal impairment, respectively. The terminal half-life also increased with decreasing renal function; geometric means were 11.5, 14.1, and 20.7 h for patients with normal renal function, moderate renal impairment, and severe renal impairment, respectively. Both oral and renal clearances were linearly correlated with CLCR. A 300-mg dose of 3TC was well tolerated by all three patient groups. The pharmacokinetics of 3TC is profoundly affected by impaired renal function. Dosage adjustment, by either dose reduction or lengthening of the dosing interval, is warranted.
pubmed:grant
pubmed:commentsCorrections
http://linkedlifedata.com/resource/pubmed/commentcorrection/8726029-1244564, http://linkedlifedata.com/resource/pubmed/commentcorrection/8726029-1283519, http://linkedlifedata.com/resource/pubmed/commentcorrection/8726029-1320365, http://linkedlifedata.com/resource/pubmed/commentcorrection/8726029-1384425, http://linkedlifedata.com/resource/pubmed/commentcorrection/8726029-1590690, http://linkedlifedata.com/resource/pubmed/commentcorrection/8726029-1929298, http://linkedlifedata.com/resource/pubmed/commentcorrection/8726029-2403474, http://linkedlifedata.com/resource/pubmed/commentcorrection/8726029-3041800, http://linkedlifedata.com/resource/pubmed/commentcorrection/8726029-3390012, http://linkedlifedata.com/resource/pubmed/commentcorrection/8726029-3555070, http://linkedlifedata.com/resource/pubmed/commentcorrection/8726029-3561458, http://linkedlifedata.com/resource/pubmed/commentcorrection/8726029-7477218, http://linkedlifedata.com/resource/pubmed/commentcorrection/8726029-7751691, http://linkedlifedata.com/resource/pubmed/commentcorrection/8726029-7769277, http://linkedlifedata.com/resource/pubmed/commentcorrection/8726029-7952073, http://linkedlifedata.com/resource/pubmed/commentcorrection/8726029-8003552, http://linkedlifedata.com/resource/pubmed/commentcorrection/8726029-8750368
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Jun
pubmed:issn
0066-4804
pubmed:author
pubmed:issnType
Print
pubmed:volume
40
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
1514-9
pubmed:dateRevised
2009-11-18
pubmed:meshHeading
pubmed:year
1996
pubmed:articleTitle
Pharmacokinetics of lamivudine in human immunodeficiency virus-infected patients with renal dysfunction.
pubmed:affiliation
Department of Medicine, Duke University Medical Center, Durham, North Carolina 27710, USA.
pubmed:publicationType
Journal Article, Clinical Trial, Research Support, U.S. Gov't, P.H.S.