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. |
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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. |