Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00335686
Status:
COMPLETED
Last Update Posted:
2008-02-29
First Post:
2006-06-08
Brief Title:
Study on the Effect of Kaletra Nevirapine as Maintenance Bitherapy Compared to a Triple Therapy Including Kaletra Analogues in HIV Patients
Sponsor:
Germans Trias i Pujol Hospital
Organization:
Germans Trias i Pujol Hospital
Study Overview
Official Title:
Randomised Prospective Multicentre Clinical Study on the Effect of the Combination of LopinavirRtv Nevirapine as Maintenance Bitherapy Without Nucleoside Analogues in Comparison With a Triple Therapy Including LopinavirRtv Nucleoside Analogues in HIV-Infected Patients
Status:
COMPLETED
Status Verified Date:
2007-06
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:
The study aims to evaluate the changes in mitochondrial DNA mDNA by means of the mDNAnuclearDNA nDNA ratio as a marker of mitochondrial toxicity following the interruption of nucleoside analogues
Detailed Description:
At the moment it is known that mitochondrial toxicity is the main pathogenic mechanism of toxicity associated with nucleoside analogues including lipoatrophy which at facial level is a stigmatising factor for patients with HIV infection
The primary outcome measure of the design of an NTRI-sparing bitherapy is to retard the onset of mitochondrial toxicity or reverse it mainly with regard to the loss of subcutaneous fat or lipoatrophy
Lopinavirritonavir and nevirapine are two antiretrovirals with different mutation patterns and with high antiviral potency Their combination therefore guarantees antiviral success The NEKA study endorses efficacy immunologically and virologically Negredo E et al NRTI-sparing regimen XIV International AIDS Conference Barcelona 2002 LB PeB9021
Similarly the protective effect of nevirapine on lipid metabolism would counteract the negative impact attributed to lopinavirritonavir reducing cardiovascular risk in these patients
The primary outcome measure of the design of an NTRI-sparing bitherapy is to retard the onset of mitochondrial toxicity or reverse it mainly with regard to the loss of subcutaneous fat or lipoatrophy
Lopinavirritonavir and nevirapine are two antiretrovirals with different mutation patterns and with high antiviral potency Their combination therefore guarantees antiviral success The NEKA study endorses efficacy immunologically and virologically Negredo E et al NRTI-sparing regimen XIV International AIDS Conference Barcelona 2002 LB PeB9021
Similarly the protective effect of nevirapine on lipid metabolism would counteract the negative impact attributed to lopinavirritonavir reducing cardiovascular risk in these 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