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

Swaminathan 2011.

Methods An open‐label, parallel arm, randomized controlled clinical trial conducted at 3 sites of the Tuberculosis Research Centre in Chennai, Vellore, and Madurai, located in southern India.
Participants 564 participants
Inclusion criteria: People living with HIV who were at least 18 years of age with newly diagnosed TB, not pregnant and CD4+ cell counts < 250 cells/mm3.
Exclusion criteria: previous ATT or ART for > 1month, HIV‐2 infection, major psychiatric illness, aspartate aminotransferase and alanine aminotransferase levels > 2.5 times the upper limit of normal and having a severe non‐HIV related disease.
Interventions Didanosine (250/400 mg) + lamivudine (300 mg) + nevirapine (400mg after 14 days of 200 mg) or didanosine (250/400 mg) + lamivudine (300 mg) + efavirenz (600 mg)
Outcomes Change in CD4 count, discontinuation rate, adherence rate, treatment failure, mortality, and adverse events.
Notes Funded by the National AIDS Control Organization (New Delhi, India) and Indian Council of Medical Research (New Delhi, India). NCT00332306
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The trial authors performed permuted block randomisation.
Allocation concealment (selection bias) Low risk The trial conducted randomization centrally and statisticians prepared allocation codes in sealed and opaque envelopes for each site.
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 groups and the trial authors reported 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 Demographic characteristics, CD4 count, and viral load.
Other bias Low risk We did not identify any other sources of bias.