Wegner 2004.
Methods | A prospective randomized 3‐arm multi‐centre clinical trial at 6 military hospitals in the USA | |
Participants | 450 participants Inclusion: at least 18 years of age, receiving a stable ART regimen containing ≥ 2 drugs for at least 8 weeks before randomization, able to provide informed consent, willing to attend regular study visits Exclusion: not reported |
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Interventions | Intervention 1: routine access to phenotype testing (PT) Intervention 2: routine access to genotype testing (GT) Control: no access to resistance testing (VB) |
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Outcomes | Treatment failure, discontinuation | |
Notes | All participants provided informed consent. Funding: US Army Medical Research and Material Command and the Henry M. Jackson Foundation for the Advancement of Military Medicine |
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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 | The randomization procedure was centrally located. |
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 | High risk | Losses to follow‐up were balanced between groups but were considerable (> 65%). |
Selective reporting (reporting bias) | High risk | Only treatment failure and discontinuation were reported. |
Other bias | Low risk | We found no other sources of bias. |
Overall risk assessment | High risk | Risk is due to the uncertainties raised above. |
Abbreviations: ART: antiretroviral therapy; CG: control group; EA: expert advice; G: genotyping; GART: genotypic antiretroviral resistance testing; GG: genotypic group; GT: genotype testing; ITT: intention‐to‐treat; NNRTI: non‐nucleoside reverse transcriptase inhibitor; NRTI: nucleoside reverse transcriptase inhibitor; P: phenotyping; PI: protease inhibitor; PRT: phenotypic resistance testing; PT: phenotype testing; SOC: standard of care; VB: XXX; VL: viral load.