Meynard 2002.
Methods | A multi‐centre randomized trial in France | |
Participants | 541 participants Inclusion: plasma HIV‐1 RNA 1000 copies/mL; previous exposure to at least 1 protease inhibitor (PI) for at least 3 months; unchanged antiretroviral regimen for the 2 preceding months; over 18 years of age; Karnofsky score > 70% Exclusion: active opportunistic infection; previous resistance testing; estimated poor adherence; blood haemoglobin < 8 g/dL; blood neutrophils < 750 × 10⁶/L; serum creatinine > 150 µmol/L; serum amylase > 3 times the upper limit of normal; liver aminotransferase values > 5 times the upper limit of normal |
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Interventions | Intervention 1: phenotyping (P) arm in which the treatment choice was guided by a phenotypic test Intervention 2: genotyping (G) arm in which the treatment choice was guided by a genotypic test Control: standard of care (SOC) arm in which treatment was chosen by the clinician |
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Outcomes | Virological success (< 200 copies and < 20 copies/mL), change in viral load, change in CD4 count Follow‐up: 36 weeks |
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Notes | All participants provided informed consent. Funding: Agence Nationale de Recherche sur le Sida, Glaxo Wellcome, Abbott, Dupont‐Pharma, and Visible Genetics |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of randomization was not reported. |
Allocation concealment (selection bias) | Low risk | Arm assignments were revealed only to the investigator and patients at day 0. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | This was an open‐label study (knowledge of allocation is unlikely to introduce bias). |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Trial authors did not report this information (knowledge of allocation is unlikely to introduce bias). |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Losses to follow‐up were balanced across groups but were considerable (> 20%). |
Selective reporting (reporting bias) | Low risk | Trial authors reported all outcomes of interest. |
Other bias | Low risk | We found no other sources of bias. |
Overall risk assessment | Low risk | We had no serious risk of bias concerns. |