Raltegravir for the treatment of patients co-infected with HIV and tuberculosis (ANRS 12 180 Refl ate TB): a multicentre, phase 2, non-comparative, open-label, randomised trial.
Grinsztejn B, De Castro N, Arnold V, Veloso VG, Morgado M, Pilotto JH, Brites C, Valdez Madruga J, Tregnago Barcellos N, Riegel Santos B, Vorsatz C, Fagard C, Santini-Oliveira M, Patey O, Delaugerre C, Chêne G, Molina JM for the ANRS 12 180 Refl ate TB study group.
Lancet Infect Dis 2014; 14: 459–67

18 Novembre 2014, by Dr Anton Pozniak

Reflate-TB (ANRS 12180) is a multi-center, phase 2, non comparative, open-label, randomised trial, conducted in Brazil and in France. Antiretroviral naïve adults with HIV-1 infection and tuberculosis were randomised 1:1:1 to receive raltegravir 400 mg twice daily, raltegravir 800 mg twice daily or efavirenz 600 mg once daily, plus tenofovir and lamivudine. Antiretroviral treatment was started after two to eight weeks of tuberculosis treatment. Tuberculosis treatment was standard: isoniazide, rifampicine, pyrazinamide, and ethambutol for the first 2 months, followed by isoniazide and rifampicine for a minimum of 4 months. The results for the primary endpoint (HIV RNA below 50 copies/mL in the modified intention to treat analysis) was as follow: 76% (39/51) for raltegravir 400 mg BID, 78% (40/51) for raltegravir 800 mg BID and 63% (32/51) for efavirenz. Seven patients died during the study: 1 in the raltegravir 400 mg group, 4 in the raltegravir 800 mg group and 2 in the efavirenz group. Six patients discontinued the study drugs due to adverse events: 3 in the raltegravir 800 mg group and 3 in the efavirenz group.
In conclusion, raltegravir 400 mg twice a day might be an alternative to efavirenz for the treatment of HIV infected patients co-infected with tuberculosis.

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