Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00247143
Status:
UNKNOWN
Last Update Posted:
2006-09-20
First Post:
2005-10-28
Brief Title:
High Dose RitonavirLopinavir Liquid Formulation in Salvage Therapy for Protease Inhibitor Resistant HIV Disease
Sponsor:
Lampiris Harry W MD
Organization:
Lampiris Harry W MD
Study Overview
Official Title:
Prospective Open Label Non-Comparative Study of the Safety Efficacy and Tolerability of High Dose RitonavirLopinavir Liquid in Salvage Therapy for PI Resistant HIV a PK Equivalence Sub-Study of High Dose RitonavirLopinavir Capsules
Status:
UNKNOWN
Status Verified Date:
2006-09
Last Known Status:
RECRUITING
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:
The purpose of this study is to evaluate the safety tolerability and efficacy of higher doses of lopinavirritonavir in combination with other anti-HIV medications when administered as either the capsule or liquid formulations among patients who have not had full viral suppression despite treatment with 3 classes of HIV medications and at least 2 prior courses of treatment with HIV protease inhibitors In addition pharmacokinetics of the active agents lopinavir and ritonavir will be measured following administration of both the liquid and capsule formulations and compared
Detailed Description:
This study is a safety efficacy and tolerability study of high dose kaletra in patients who have failed multiple antiretroviral regimens including prior treatment with 3 classes of antiretroviral drugs nucleosidenucleotide analogues non-nucleoside analogues and at least one protease inhibitor based ARV regimen in conjunction with optimized background therapy Patients will initially be treated with high dose kaletra capsules and optimized background therapy for 4 weeks and then switched to equivalent doses of high dose kaletra liquid formulation for a total duration of therapy of 24 weeks The primary endpoint of the study will be the average HIV RNA change from baseline through 24 weeks HIV RNA AACUMB Secondary endpoints will include the proportion achieving HIV RNA 50 and HIV RNA 400 copiesmL at 24 weeks Changes in CD4 from baseline change in LPV fold change in phenotypic resistance testing changes in fasting metabolic parameters assessment of safety at week 24 based upon hematology chemistry liver function lipid levels proportion of patients reporting adverse events and proportion of patients with SAEs and demonstration of bioequivalence by 12 hour pharmacokinetic measurements
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