Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00415090
Status:
COMPLETED
Last Update Posted:
2008-10-31
First Post:
2006-12-19
Brief Title:
Study to Evaluate the Replacement of Reverse Transcriptase NucleosideNucleotide Inhibitors by Nevirapine in Patients on Triple Treatment With Analogues Only
Sponsor:
Hospital de Calella
Organization:
Hospital de Calella
Study Overview
Official Title:
Substitution by Nevirapine in HIV-1 Infected Patients on Triple Treatment of Reverse Transcriptase NucleosideNucleotide Inhibitors
Status:
COMPLETED
Status Verified Date:
2008-10
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 study is to evaluate the proportion of patients with viral load of HIV-1 50 copies after 48 weeks of follow-up after randomization to change or not to nevirapine
Detailed Description:
RTNI reverse transcriptase nucleoside inhibitors are a regular part of most antiretroviral combinations The presence of a smaller or greater degree of cross resistance among all RTNI is increasingly better described and acknowledged whereby the number of salvage regimens that may be built following the appearance of this resistance to these drugs is by no means unlimited
This proactive treatment change in patients on RTNI-based regimens while the viral load is still suppressed would avoid the selective replication period under antiviral pressure following the failure of the regimen in which resistance-associated mutations accumulate This therapeutic approach has demonstrated its effectiveness in clinical practice albeit not in this scenario
If we wait until the viral load is detectable there is sufficient evidence that resistance to RTNI will appear and that this resistance will compromise future salvage options
To intensify with this proactive approach these combinations based on NNNRTI nucleotide analog the NNRTI are an optimal alternativeThere is vast experience with NVP in simplificationmaintenance trials In direct comparative simplification studies in patients with virological response the response rates with NVP or EFV have shown no differences With a relative risk RR of virological failure of 054 with regard to the continuation of PI protease inhibitors NVP is one of the best simplification treatment options in HIV-1-infected patients
This proactive treatment change in patients on RTNI-based regimens while the viral load is still suppressed would avoid the selective replication period under antiviral pressure following the failure of the regimen in which resistance-associated mutations accumulate This therapeutic approach has demonstrated its effectiveness in clinical practice albeit not in this scenario
If we wait until the viral load is detectable there is sufficient evidence that resistance to RTNI will appear and that this resistance will compromise future salvage options
To intensify with this proactive approach these combinations based on NNNRTI nucleotide analog the NNRTI are an optimal alternativeThere is vast experience with NVP in simplificationmaintenance trials In direct comparative simplification studies in patients with virological response the response rates with NVP or EFV have shown no differences With a relative risk RR of virological failure of 054 with regard to the continuation of PI protease inhibitors NVP is one of the best simplification treatment options in HIV-1-infected patients
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