Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00281606
Status:
COMPLETED
Last Update Posted:
2020-06-30
First Post:
2006-01-23
Brief Title:
A Multicenter Study to Assess the Tolerability of Once Daily LopinavirRitonavir LPVr Liquid Versus Capsules
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
A Phase IV Randomized Open-label Study of the Tolerability of Once Daily LopinavirRitonavir LPVr Liquid Versus Capsules
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Guidelines have continued to list lopinavirritonavir as a preferred protease inhibitor-containing regimen for HIV-infected individuals There has recently been increasing interest in once daily therapy While lopinavirritonavir 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 lopinavirritonavir 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
Detailed Description:
This study is designed to assess the tolerability of different forms liquid capsules or tablets of lopinavirritonavir given once-daily as part of combination therapy for HIV infection Study subjects will be those tolerating a stable regimen of HIV medications with undetectable levels of HIV in their blood They will be assigned by chance to receive once daily liquid or soft gel capsules of lopinavirritonavir for up to four weeks At that time they will receive the alternative formulation for up to four weeks They will then be given once daily lopinavirritonavir in the recently released tablet formulation After up to four weeks of each of these formulations several assessments will be made of the overall tolerability of the drug After four weeks of tablets they will be allowed to take whatever regimen they want and will be followed for an additional 36 weeks for a total duration of study of up to 48 weeks The pharmacokinetics of each formulation of lopinavirritonavir given once daily will also be assessed in a subset of study subjects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None