Cohen 2002.
Methods | A prospective open‐label randomized controlled clinical trial conducted at 25 university and private practice centres in the USA | |
Participants | 272 participants Inclusion: at least 13 years of age; documented HIV‐1 infection; HIV‐ 1‐RNA plasma levels ≥ 2000 copies/mL; antiretroviral experience; experiencing virological failure on antiretroviral treatment consisting of ≥ 2 NRTIs and only 1 PI, taken for at least 1 month before screening Exclusion: history of alcohol or drug use judged as likely to interfere with therapy; previous phenotypic resistance testing; had participated in an antiretroviral drug trial within 30 days of selection or during the trial; had a life expectancy < 6 months; had disease that could interfere with assessments NB: Patients with previous NNRTI therapy were later allowed to participate. |
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Interventions | Intervention: phenotypic resistance testing (PRT) (i.e. antiretroviral regimens chosen with PRT and external expert advice coupled with access to published treatment guidelines and participants' treatment histories) Control: standard of care (SOC) (i.e. antiretroviral regimens chosen on the basis of access to published treatment guidelines and participants' treatment histories) |
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Outcomes | Virological success (< 400 copies/mL), change in viral load, change in CD4 cell count Follow‐up: 16 weeks |
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Notes | All participants provided informed consent. Study was funded by Glaxo Wellcome, Inc. (primary) and Virco NV. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomly assigned to intervention and control groups. |
Allocation concealment (selection bias) | Low risk | Centrally located randomization was used with block size of 4. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Arm assignments were not blinded (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 between groups. Trial authors performed ITT analyses. |
Selective reporting (reporting bias) | Low risk | Trial authors reported all outcomes of interest. |
Other bias | High risk | Study was supported by manufacturers of resistance tests. |
Overall risk assessment | High risk | Risk is due to the uncertainties raised above. |