drugset / Trial / NCT00495326
Comparison of Nevirapine and Efavirenz for the Treatment of HIV-TB Co-infected Patients (ANRS 12146 CARINEMO)
Phase 2/3
Completed
570 enrolled
French National Agency for Research on AIDS and Viral Hepatitis
Medecins Sans Frontieres, Netherlands · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2007-12
- Primary completion
- 2011-04
- Completion
- 2011-04
Outcome
Missed primary endpoint
paper Although non-inferiority of the nevirapine-regimen was not shown PMID 23433590 ↗
Publications
- 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.
- Bonnet 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Efavirenz | Other / unclassified | 600 mg | — |
| Subject | Nevirapine | Small molecule | 200 mg | — |
| Background | Ethambutol | Small molecule | — | — |
| Background | Isoniazid | Small molecule | 5 mg/kg | — |
| Comparator | Lamivudine | Other / unclassified | 150 mg | — |
| Comparator | Lamivudine | Other / unclassified | 300 mg | — |
| Background | Pyrazinamid | Unknown | — | — |
| Background | Rifampicin | Small molecule | 10 mg/kg | — |
| Comparator | Stavudine | Other / unclassified | 30 mg | — |
| Comparator | Stavudine | Other / unclassified | 40 mg | — |
| Background | streptomycin | Other / unclassified | — | — |