• treatment success rate at week 48 (W48)
  
• plasma HIV-1 RNA is less than 50 copies/mL at W48
  
• tuberculosis is cured at W48
  

• course of plasma HIV-1 RNA
  
• tuberculosis cure rate
  
• safety of trial treatments (number of events, description, time to onset, metabolic disorders, immune restoration syndrome)
  
• frequency of treatment changes or discontinuations
  
• clinical progression of HIV infection
  
• course of CD4 T lymphocytes
  
• study of resistance in the case of virological failure
  
• study of compliance and quality of life
  
• pharmacokinetic study of tuberculostatic agents
  
• effect of treatment on hepatitis B viral replication
  

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.