Comparison of Nevirapine and Efavirenz for the Treatment of HIV-TB Co-infected Patients (ANRS 12146 CARINEMO) (CARINEMO)
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|ClinicalTrials.gov Identifier: NCT00495326|
Recruitment Status : Completed
First Posted : July 3, 2007
Last Update Posted : February 15, 2012
|Condition or disease||Intervention/treatment||Phase|
|Tuberculosis Aids Hiv Infections||Drug: Nevirapine based therapy Drug: Efavirenz based therapy Drug: Rifampicin (RMP) Ethambutol (E) Isoniazid (H) Pyrazinamid (Z)||Phase 2 Phase 3|
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 HIV/TB 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||570 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||December 2007|
|Primary Completion Date :||April 2011|
|Study Completion Date :||April 2011|
Drug: Nevirapine based therapy
Other Name: TriomuneDrug: Rifampicin (RMP) Ethambutol (E) Isoniazid (H) Pyrazinamid (Z)
Active Comparator: 2
Drug: Efavirenz based therapy
Efavirenz EFV 200 mg (3 tablets/d) Lamivudine 3TC 300mg (2 tablets of 150mg/d) D4T generic 30mg or 40mg (2 tablets/d)
Other Names:Drug: Rifampicin (RMP) Ethambutol (E) Isoniazid (H) Pyrazinamid (Z)
- Viral load measure (Virological failure will be defined after 2 consecutive measures as : More than 1 log10 increase in plasma HIV-1 RNA concentration for patients with detectable viral load (> 50 copies/mL) at the previous dosage.) [ Time Frame: 3, 6 and 12 months ]
- New or recurrent stage 3 or 4 HIV/AIDS related events [ Time Frame: 12 months ]
- Deaths after one year [ Time Frame: 12 months ]
- Severe drugs side effects [ Time Frame: 12 months ]
- Immune Reconstitution Syndrome(IRIS) [ Time Frame: 12 months ]
- Increase of CD4 cell count induced by HAART [ Time Frame: at 6 months and 1 year ]
- Pharmacokinetic profile of nevirapine when combined with rifampicin [ Time Frame: 2 months ]
- Rifampicin plasma concentration dosage [ Time Frame: 2 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00495326
|Health centre of Alto Mae, Chamanculo district|
|Health centre of Josue Macao|
|Health centre of Malavane|
|Principal Investigator:||Maryline Bonnet, MD||Epicentre|
|Principal Investigator:||Nilesh Bhatt, MD||Ministry of Health, Instituto Nacional de Saude, Mozambique|