Comparison of Nevirapine and Efavirenz for the Treatment of HIV-TB Co-infected Patients (ANRS 12146 CARINEMO)
CARINEMO
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)
1 other identifier
interventional
570
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2007
Typical duration for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2007
CompletedFirst Posted
Study publicly available on registry
July 3, 2007
CompletedStudy Start
First participant enrolled
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedFebruary 15, 2012
February 1, 2012
3.3 years
July 2, 2007
February 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.)
3, 6 and 12 months
Secondary Outcomes (7)
New or recurrent stage 3 or 4 HIV/AIDS related events
12 months
Deaths after one year
12 months
Severe drugs side effects
12 months
Immune Reconstitution Syndrome(IRIS)
12 months
Increase of CD4 cell count induced by HAART
at 6 months and 1 year
- +2 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALNevirapine-based ART
2
ACTIVE COMPARATOREfavirenz-based ART
Interventions
* Patients below 60 kg: 1 tablet twice a day of Triomune30®, including NVP 200 mg, 3TC 150 mg and D4T 30mg * Patients above 60kg: 1 tablet twice a day of Triomune40®, including NVP 200 mg, 3TC 150 mg and D4T 40 mg)
Efavirenz EFV 200 mg (3 tablets/d) Lamivudine 3TC 300mg (2 tablets of 150mg/d) D4T generic 30mg or 40mg (2 tablets/d)
* Intensive phase: 2 months daily E(RMP)HZ. PTB smear positive patients at month 2 will receive 1 more month intensive phase. * Continuation phase: 4 months daily H(RMP). * Patients with meningitis will receive Streptomycin instead of E during intensive phase.
Eligibility Criteria
You may qualify if:
- Person HIV infected
- Aged of 18 years or more
- Signed informed consent
- New case of tuberculosis: patient who never received TB treatment or for less than 1 month
- Patients receiving rifampicin based TB regimen since 4 to 6 weeks
- CD4 cell count \< 250 cell/mm3 in the 4 weeks following the TB diagnosis
- Naïve of HAART
- For women of childbearing age, to have a negative plasmatic test for pregnancy and to accept to take a contraception or declare no wish of pregnancy in the coming year.
You may not qualify if:
- To have a positive plasmatic test for pregnancy
- Karnofsky score \<60%
- ALAT \> 4N (Hepatitis grade 3 or 4)
- Ongoing psychiatric pathology
- Refuse to participate in the study
- Amendment :
- bilirubin \> grade 3
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Health centre of Alto Mae, Chamanculo district
Maputo, Mozambique
Health centre of Josue Macao
Maputo, Mozambique
Health centre of Malavane
Maputo, Mozambique
Related Publications (2)
Bhatt NB, Barau C, Amin A, Baudin E, Meggi B, Silva C, Furlan V, Grinsztejn B, Barrail-Tran A, Bonnet M, Taburet AM; ANRS 12146-CARINEMO Study Group. Pharmacokinetics of rifampin and isoniazid in tuberculosis-HIV-coinfected patients receiving nevirapine- or efavirenz-based antiretroviral treatment. Antimicrob Agents Chemother. 2014 Jun;58(6):3182-90. doi: 10.1128/AAC.02379-13. Epub 2014 Mar 24.
PMID: 24663014DERIVEDBonnet M, Bhatt N, Baudin E, Silva C, Michon C, Taburet AM, Ciaffi L, Sobry A, Bastos R, Nunes E, Rouzioux C, Jani I, Calmy A; CARINEMO study group. Nevirapine versus efavirenz for patients co-infected with HIV and tuberculosis: a randomised non-inferiority trial. Lancet Infect Dis. 2013 Apr;13(4):303-12. doi: 10.1016/S1473-3099(13)70007-0. Epub 2013 Feb 20.
PMID: 23433590DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maryline Bonnet, MD
Epicentre
- PRINCIPAL INVESTIGATOR
Nilesh Bhatt, MD
Ministry of Health, Instituto Nacional de Saude, Mozambique
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2007
First Posted
July 3, 2007
Study Start
December 1, 2007
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
February 15, 2012
Record last verified: 2012-02