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. |
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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. |