• 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.) [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
  

• New or recurrent stage 3 or 4 HIV/AIDS related events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  
• Deaths after one year [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  
• Severe drugs side effects [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  
• Immune Reconstitution Syndrome(IRIS) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  
• Increase of CD4 cell count induced by HAART [ Time Frame: at 6 months and 1 year ] [ Designated as safety issue: No ]
  
• Pharmacokinetic profile of nevirapine when combined with rifampicin [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  

Anti Retroviral Therapy (ART) reduces tuberculosis (TB) incidence in HIV-infected patients and reduces mortality among TB patients with deep immune suppression. The Fixed Drug Combination (FDC) nevirapine (NVP)-lamivudine-stavudine is the first line ART available for low-income countries. Rifampicin (RMP), due to its liver induction effect, reduces significantly NVP plasma concentration, raising concerns regarding the risk of resistance and subsequent treatment failure. Therefore, in co-infected patients, WHO recommends delaying ART or using efavirenz (EFV)-based ART. Although EFV is also reduced at lower level, longitudinal studies report good efficacy and safety when given concomitantly with RMP.

In low-income countries, poor access to EFV, contradiction during pregnancy and absence of FDC containing EFV lead to difficulties in HIV-TB treatment.

Despite 2 limited retrospective studies and a non-randomised prospective study, which report good virological response at 6 months in co-infected patients receiving NVP and RMP co-administration, existing data are too limited to change the recommendation.

The aim of the study is to compare, in terms of therapeutic efficacy and clinical safety, the nevirapine-based HAART to the standard efavirenz-based HAART, in HIV/TB co-infected patients receiving a rifampicin-based TB treatment.

The study will evaluate one year after TB treatment initiation, whether the HAART efficacy (virological outcome, death or lost of follow-up) induced by NVP-based HAART is non-inferior to those induced by EFV based HAART, in patients receiving concomitantly HAART and RMP-based TB treatment.