A Multicenter Study to Assess the Tolerability of Once Daily Lopinavir/Ritonavir (LPV/r) Liquid Versus Capsules
Status:
Completed
Trial end date:
2012-06-13
Target enrollment:
Participant gender:
Summary
Guidelines have continued to list lopinavir/ritonavir as a preferred protease
inhibitor-containing regimen for HIV-infected individuals. There has recently been increasing
interest in once daily therapy. While lopinavir/ritonavir has recently been approved as a
once daily therapy it was associated with considerable diarrhea in those treated with soft
gel capsules. It is the hope that alternative formulations of lopinavir/ritonavir may provide
similar pharmacokinetics with improved tolerability. This includes the possibility of using
liquid or newly released tablets. This study will treat people tolerating their current
regimen with up to four weeks of each formulation with several assessments of
pharmacokinetics and tolerability for each.
Phase:
Phase 4
Details
Lead Sponsor:
California Collaborative Treatment Group University of California, San Diego