Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114933
Status:
COMPLETED
Last Update Posted:
2008-03-21
First Post:
2005-06-20
Brief Title:
OK 2004 Study Only Kaletra 2004 Study Study to Evaluate Suspending Nucleosides From Triple-Drug Therapy in HIV Subjects
Sponsor:
Arribas Jose R MD
Organization:
Arribas Jose R MD
Study Overview
Official Title:
Phase III-IV Comparative Randomized Open-Label Study to Evaluate Safety and Efficacy of Suspending Nucleosides From a Triple-Drug Therapy Based on LopinavirRitonavir Versus Continuing Triple-Drug Therapy in HIV-Infected Subjects With Undetectable Plasma HIV Viremia for Six Months
Status:
COMPLETED
Status Verified Date:
2005-09
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:
Lopinavirritonavir monotherapy may maintain virologic suppression in patients who have been undetectable for six months while on triple drug antiretroviral therapy Lopinavirritonavir pharmacokinetics might prevent resistance development in patients who experience virological rebound after single-drug simplification
Detailed Description:
Primary Study Objective Efficacy and durability of switching to lopinavirritonavir single-drug HAART compared to maintaining therapy based on lopinavirritonavir and two nucleosides
Secondary Study Objectives
Safety related drug AEsSAEs and laboratory anomalies G34 through 48 w
Resistance profile on patients with sustained virological failure
QOL comparing stopping nucleosides versus continuing therapy
Pharmaco-economic analysis comparing treatment cost between the 2 study arms
Predicting factors of failure in the stopping nucleosides arm
Subject Population 200 patients
Study Design
RANDOMIZATION
Patients are randomized 11 either to continue under the same treatment or stop nucleosides as follows
Stopping nucleosides arm Lopinavirr alone
Continuing arm Lopinavirr 2 NRTIs
STUDY PROCEDURES A baseline HIV-RNA CD4 and routine labs will be collected if the most recent results are not collected within the 4 weeks prior entering the study Patients will be followed for HIV-RNA and CD4 at w1 w4 w8 w16 w24 w 36 and w48 After w48 durability of response to lopinavirr single-drug therapy will be studied long-term up to w96 Routine hematology and clinical chemistry including fasting triglycerides and cholesterol total and HDLLDL ratio will be measured at w4 w16 w24 w 36 and w48 A central laboratory will be used for HIV-RNA determinations and to archive plasmacell samples for further genotype test in case of rebound
Treatment adherence will be followed with a self-patient report questionnaire GEEMA study
All AEs will be collected if suspected relation possible or probable to any concomitant ARV drug and SAEs related or not reported within 24h
Secondary Study Objectives
Safety related drug AEsSAEs and laboratory anomalies G34 through 48 w
Resistance profile on patients with sustained virological failure
QOL comparing stopping nucleosides versus continuing therapy
Pharmaco-economic analysis comparing treatment cost between the 2 study arms
Predicting factors of failure in the stopping nucleosides arm
Subject Population 200 patients
Study Design
RANDOMIZATION
Patients are randomized 11 either to continue under the same treatment or stop nucleosides as follows
Stopping nucleosides arm Lopinavirr alone
Continuing arm Lopinavirr 2 NRTIs
STUDY PROCEDURES A baseline HIV-RNA CD4 and routine labs will be collected if the most recent results are not collected within the 4 weeks prior entering the study Patients will be followed for HIV-RNA and CD4 at w1 w4 w8 w16 w24 w 36 and w48 After w48 durability of response to lopinavirr single-drug therapy will be studied long-term up to w96 Routine hematology and clinical chemistry including fasting triglycerides and cholesterol total and HDLLDL ratio will be measured at w4 w16 w24 w 36 and w48 A central laboratory will be used for HIV-RNA determinations and to archive plasmacell samples for further genotype test in case of rebound
Treatment adherence will be followed with a self-patient report questionnaire GEEMA study
All AEs will be collected if suspected relation possible or probable to any concomitant ARV drug and SAEs related or not reported within 24h
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT 2004-001323-37 | None | None | None |