Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00495326
Status:
COMPLETED
Last Update Posted:
2012-02-15
First Post:
2007-07-02
Brief Title:
Comparison of Nevirapine and Efavirenz for the Treatment of HIV-TB Co-infected Patients ANRS 12146 CARINEMO
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
French National Agency for Research on AIDS and Viral Hepatitis
Study Overview
Official Title:
Randomized Non-inferiority Trial Comparing the Nevirapine-based Antiretroviral Therapy Versus the Standard Efavirenz-based ART for the Treatment of HIV-TB Co-infected Patients on Rifampicin-based Therapy ANRS 12146 CARINEMO
Status:
COMPLETED
Status Verified Date:
2012-02
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:
CARINEMO
Brief Summary:
The purpose of this study is to determine whether the use of Nevirapine in HIV patients already treated against tuberculosis by Rifampicin is as efficient and as well tolerated as Efavirenz
Detailed Description:
Anti Retroviral Therapy ART reduces tuberculosis TB incidence in HIV-infected patients and reduces mortality among TB patients with deep immune suppression The Fixed Drug Combination FDC nevirapine NVP-lamivudine-stavudine is the first line ART available for low-income countries Rifampicin RMP due to its liver induction effect reduces significantly NVP plasma concentration raising concerns regarding the risk of resistance and subsequent treatment failure Therefore in co-infected patients WHO recommends delaying ART or using efavirenz EFV-based ART Although EFV is also reduced at lower level longitudinal studies report good efficacy and safety when given concomitantly with RMP
In low-income countries poor access to EFV contradiction during pregnancy and absence of FDC containing EFV lead to difficulties in HIV-TB treatment
Despite 2 limited retrospective studies and a non-randomised prospective study which report good virological response at 6 months in co-infected patients receiving NVP and RMP co-administration existing data are too limited to change the recommendation
The aim of the study is to compare in terms of therapeutic efficacy and clinical safety the nevirapine-based HAART to the standard efavirenz-based HAART in HIVTB co-infected patients receiving a rifampicin-based TB treatment
The study will evaluate one year after TB treatment initiation whether the HAART efficacy virological outcome death or lost of follow-up induced by NVP-based HAART is non-inferior to those induced by EFV based HAART in patients receiving concomitantly HAART and RMP-based TB treatment
In low-income countries poor access to EFV contradiction during pregnancy and absence of FDC containing EFV lead to difficulties in HIV-TB treatment
Despite 2 limited retrospective studies and a non-randomised prospective study which report good virological response at 6 months in co-infected patients receiving NVP and RMP co-administration existing data are too limited to change the recommendation
The aim of the study is to compare in terms of therapeutic efficacy and clinical safety the nevirapine-based HAART to the standard efavirenz-based HAART in HIVTB co-infected patients receiving a rifampicin-based TB treatment
The study will evaluate one year after TB treatment initiation whether the HAART efficacy virological outcome death or lost of follow-up induced by NVP-based HAART is non-inferior to those induced by EFV based HAART in patients receiving concomitantly HAART and RMP-based TB treatment
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