Landman 2014.
| Methods | A multicenter, open‐label randomized trial conducted in 2 centres in Dakar, Senegal and Yaoundé, Cameroon. | |
| Participants | 120 participants. Inclusion criteria: adults (≥ 18 years in Senegal or ≥ 21 years in Cameroon), anti‐retroviral treatment naïve, and CD4+ T‐cell count > 50 cells/mm3 Exclusion criteria: ongoing opportunistic infection, serious disease, ongoing treatment with rifampin, severe renal or hepatic disorder, Cockcroft‐Gault calculated creatinine clearance ≤ 50 mL/min, hepatitis B surface antigen‐positive, haemoglobin < 8 g/dL, neutrophil count < 500 cells/mm3, pregnant, breastfeeding, treated with any contraindicated drugs. |
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| Interventions | TDF/FTC 300/200 mg once daily and NVP 200 mg once daily for first 2 weeks and twice daily thereafter (N = 31) or TDF/FTC/EFV 300/200/600 mg once daily (N = 30) | |
| Outcomes | Virological efficacy (< 50 copies/mL), discontinuation rate, adherence rate, treatment failure, mortality, and adverse events | |
| Notes | Written informed consent was obtained from each participant. Trial number NCT00573001. Funding for the study was provided by the ANRS. Gilead Sciences, Merck Sgaro & Dhome, and Abbott Laboratories provided funding for some of the antiretroviral regimens. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | The trial randomized participants to treatment. |
| Allocation concealment (selection bias) | Low risk | Through a centralized web site, participants were randomized to 1 of the 4 treatment groups at an allocation ratio of 1:1:1:1. |
| 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 the reasons for dropouts. The trial authors used ITT analyses. |
| Selective reporting (reporting bias) | Low risk | The trial authors reported on all outcomes of interest. |
| Baseline data reported? | Low risk | The trial authors reported demographic characteristics, clinical stage, CD4 count, and viral load. |
| Other bias | High risk | Private funding. |