ACTG 382--DMP 266 IN COMBINATION WITH NELFINAVIR IN HIV INFECTED CHILDREN

$0M01FY2000RRNIH

Children'S Hospital Of Philadelphia, Philadelphia PA

Investigators

Linked publications & trials

Paper 37402774 Paper 35135359 Paper 35118727 Paper 34886679 Paper 34356046 Paper 33093519 Paper 32795677 Paper 32561914 Paper 32516339 Paper 31729158 Paper 31314787 Paper 31141530 Paper 30372552 Paper 30265344 Paper 28743860 Paper 28468790 Paper 26885808 Paper 26585995 Paper 26226985 Paper 26092599 Paper 25882907 Paper 25683819 Paper 25232777 Paper 25130421 Paper 24777943 Paper 24677430 Paper 24345827 Paper 23802135 Paper 23628837 Paper 23604262 Paper 23439301 Paper 23427188 Paper 23382092 Paper 23360096 Paper 22621754 Paper 22383118 Paper 22357070 Paper 22010865 Paper 21987465 Paper 21940205 Paper 21917867 Paper 21874618 Paper 21385513 Paper 21311500 Paper 21256423 Paper 21254360 Paper 21087573 Paper 21036173 Paper 20506525 Paper 20437614 Paper 20418300 Paper 20338795 Paper 20194709 Paper 20138299 Paper 20123264 Paper 20111745 Paper 20103654 Paper 20031554 Paper 19969305 Paper 19947855 Paper 19933732 Paper 19857355 Paper 19855250 Paper 19841125 Paper 19812581 Paper 19779474 Paper 19778749 Paper 19777601 Paper 19750922 Paper 19703674 Paper 19667944 Paper 19660971 Paper 19560477 Paper 19344194 Paper 19328266 Paper 19307814 Paper 19171714 Paper 19112531 Paper 19101853 Paper 19090330 Paper 19033189 Paper 19028390 Paper 19026647 Paper 19016583 Paper 18831064 Paper 18755325 Paper 18725060 Paper 18703961 Paper 18687424 Paper 18658113 Paper 18565443 Paper 18555484 Paper 18553493 Paper 18535546 Paper 18534620 Paper 18524659 Paper 18457241 Paper 18385794 Paper 18381540 Paper 18363317

Abstract

This is a phase I/II study to determine the safety, pharmacokinetics and antiviral activity of efavirenz in combination with nelfinavir and nucleoside reverse transcriptase inhibitors in HIV-infected children. Children enrolled in Cohort I will receive efavirenz capsules, while those enrolled in Cohort II will receive efavirenz liquid suspension. For both cohorts, pharmacokinetic studies were obtained for efavirenz and nelfinavir at weeks 2, 6 and, if needed, week 10, and doses were adjusted if levels were outside of target ranges. Subjects were monitored for safety parameters, viral load, CD4 and CD8 cell counts, activation markers on CD8 cells, and lymphocyte proliferation to recall and HIV antigens. Cohort I has been enrolled fully. Enrollment of children > 2 years of age into Cohort II has been completed; enrollment of younger children will begin in the near future.

View original record on NIH RePORTER →