Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00274001
Status:
COMPLETED
Last Update Posted:
2013-11-01
First Post:
2006-01-09
Brief Title:
Quality of Life and Changes in Metabolism of Lipids and Glucose After Switching to a Nevirapine-based Regimen in HIV Patients
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
An Open Randomised Multicentre Comparative Trial to Evaluate the Benefit of Switching From a PI-based Regimen to a Nevirapine-based Regimen on the Quality of Life Patient Adherence Patients Perception of Fat Redistribution and Metabolic Changes in HIV Patients Suffering From Fat Abnormalities
Status:
COMPLETED
Status Verified Date:
2013-10
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:
The purpose of this trial is to compare the effect of switching to nevirapine Viramune-containing regimen on quality of life of patients with fat abnormalities and virological control whilst receiving a PI-based regimen
Detailed Description:
Patients will receive one of the current standard of care regimens for the treatment of HIV infection ie nevirapine Viramune must be administered in conjunction with 2NRTIs as prescribed by the investigator at the study sites Patients randomized to the nevirapine Viramune-arm of the study will receive 1x200mg tablet once daily for the first 14 days lead in period and 1x200 mg tablet twice daily at appropriately spaced intervals subsequently plus their SOC combination of 2NRTIs as prescribed by the investigators without changing their prior NRTIs Patients randomized to continue their standard treatment will receive it as prescribed by the investigators No dose modification of the study drugs is permitted during the trial The study drug will be dispensed at randomization and every four weeks thereafter until completion of 48 weeks After 6 months at least of treatment the switch from PI regimen to NVP regimen will be allowed to all patients included in the PI arm according to patients willingness In these patients AST and ALT should be checked at time 0 switch and every 2 weeks for 2 months
Study Hypothesis
Between treatment comparison of Nevirapine-based regimen versus PI-based regimen will be based on a null hypothesis of no treatment difference The null hypothesis will be no difference between the two arms at week 24 month 6th against the alternative hypothesis that the mean change in physical domain of the QoL will be 10 points score SD20 and the difference between triglycerides normalized patients will be 20
Comparisons
The primary analysis on physical domain of QoL will be performed on the changes between last observation carried forward following the LCOF approach ie visit 6 or in case of premature discontinuation visit 5 or 4 and baseline visit 2 value using fixed-effects ANCOVA model with center and treatment groups as factors and baseline value and MMA type interaction will be also included in the main model
Study Hypothesis
Between treatment comparison of Nevirapine-based regimen versus PI-based regimen will be based on a null hypothesis of no treatment difference The null hypothesis will be no difference between the two arms at week 24 month 6th against the alternative hypothesis that the mean change in physical domain of the QoL will be 10 points score SD20 and the difference between triglycerides normalized patients will be 20
Comparisons
The primary analysis on physical domain of QoL will be performed on the changes between last observation carried forward following the LCOF approach ie visit 6 or in case of premature discontinuation visit 5 or 4 and baseline visit 2 value using fixed-effects ANCOVA model with center and treatment groups as factors and baseline value and MMA type interaction will be also included in the main model
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