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. 2016 Dec 10;2016(12):CD004246. doi: 10.1002/14651858.CD004246.pub4

Bonnet 2013a.

Methods An open‐label non‐inferiority randomized trial in 3 trial sites in Maputo, Mozambique (Jose Macamo Hospital, Mavalane Hospital and Alto Mae Health Centre).
Participants 570 participants.
Inclusion criteria: adults (> 18 years) , treatment naïve, treatment for tuberculosis for less then 4 weeks, Karnofsky score of 60% or more, CD4 count < 250 cells, negative pregnancy test, alanine aminotransferase(ALAT) and bilirubin less then 5 times upper limit of normal (ULN), absence of grade 4 clinical or biological adverse events.
Exclusion criteria: not stated.
Interventions 3TC + d4T + EFZ 600 mg (N = 285) versus 3TC + d4T + NVP 200 mg twice daily (N = 285)
Outcomes Virological success (< 50 copies/mL), change in CD4, mortality, progression to AIDS, discontinuation rate, adverse events
Notes All participants provided informed consent to participate in the study. This study was funded by the French Research Agency for HIV AIDS and hepatitis (ANRS).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The trial randomly allocated participants to treatment.
Allocation concealment (selection bias) Low risk Central location randomization was conducted and communicated to site investigators.
Blinding (performance bias and detection bias) 
 All outcomes High risk Open label study.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Losses to follow‐up were balanced between the trial groups, and the trial authors reported the reasons for losses to follow‐up. The trial authors used ITT analyses.
Selective reporting (reporting bias) Low risk The trial authors reported all outcomes of interest.
Baseline data reported? Low risk The trial authors reported demographic characteristics, clinical stage, CD4 count, and viral load.
Other bias Low risk We did not identify any other sources of bias.