Efficacy of Tenofovir-Emtricitabine and Efavirenz in HIV Infected Patients With Tuberculosis (ANRS129)

• treatment success rate at week 48 (W48) [ Time Frame: W48 ] [ Designated as safety issue: Yes ]
  

• course of plasma HIV-1 RNA between W0 and W48 [ Time Frame: W48 ] [ Designated as safety issue: Yes ]
  
• tuberculosis cure rate [ Time Frame: W48 ] [ Designated as safety issue: Yes ]
  
• safety of trial treatments (number of events, description, time to onset, metabolic disorders, immune restoration syndrome) [ Time Frame: W48 ] [ Designated as safety issue: Yes ]
  
• frequency of treatment changes or discontinuations [ Time Frame: W48 ] [ Designated as safety issue: No ]
  
• clinical progression of HIV infection [ Time Frame: W48 ] [ Designated as safety issue: Yes ]
  
• course of CD4 and CD8 T lymphocytes [ Time Frame: W48 ] [ Designated as safety issue: No ]
  
• study of resistance in the case of virological failure [ Time Frame: W48 ] [ Designated as safety issue: Yes ]
  
• study of compliance and quality of life [ Time Frame: W48 ] [ Designated as safety issue: No ]
  
• pharmacokinetic study of tuberculostatic agents [ Time Frame: W02,W08,W12, W24 ] [ Designated as safety issue: Yes ]
  
• effect of treatment on hepatitis B viral replication [ Time Frame: W48 ] [ Designated as safety issue: Yes ]
  

Drug: efavirenz
800mg for patients treated by rifampicine 600mg for other patients
Other Name: Sustiva
Drug: tenofovir DF
300mg once a day
Other Name: Viread
Drug: emtricitabine
one pill of 200mg once a day
Other Name: Emtriva/FTC

The proposed research consists of conducting a pilot trial "BKVIR" designed to answer the question of whether once daily tenofovir-emtricitabine-efavirenz triple-agent therapy is effective and well tolerated when it must be initiated within three months after initiation of a three-agent or four-agent tuberculostatic therapy in antiretroviral-naive HIV-infected patients. As the proposed pilot trial comprises the initiation of antiretroviral therapy during the three months following the initiation of tuberculostatic therapy, we propose to set up systematic, continuous registration of HIV-infected patients with a diagnosis of tuberculosis in participating centers during the study period in order to evaluate their eligibility for inclusion in the pilot trial. The initial declaration phase in the register, in addition to facilitating inclusions in the pilot trial, should also allow: 1) a better understanding of the reasons for non-inclusion in the trial, allowing the eligibility criteria to be adjusted if necessary during the trial; and 2) to describe the antiretroviral therapies used during co-infection and their time of initiation in relation to tuberculostatic therapy.

This research is expected to contribute to an updating of the treatment guidelines in the context of tuberculosis in HIV-infected patients. The data collected will constitute a unique database on this issue not only in France, but also internationally, which will also be useful to optimize management strategies of these two diseases in developing countries.