Jacobson 2010b.
Methods | Randomized, double‐blind, placebo‐controlled, parallel‐group study Randomization: method not specified Allocation concealment: unclear Blinding: the objects that were blinded to were not mentioned Maximum follow‐up: 58 days |
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Participants | Age of ≧ 18 years, plasma HIV‐1 RNA level of ≧ 5000 copies/mL, CD4+ lymphocyte counts of ≧ 300/μl and no documented count being 250/μL, no antiretroviral therapy for ≧ 12 weeks, no history of an AIDS‐defining illness, and only R5 HIV‐1 detectable in the original Trofile assay (Monogram Biosciences, Inc.) | |
Interventions | Single IV doses of 10 mg/kg (N = 10) Single IV doses of 5 mg/kg (N = 10) Placebo (N = 11) |
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Outcomes | Antiviral effects (Change in HIV‐1 RNA level from baseline, log10 copies/mL; the proportion of subjects with ≧ 1 log10 copies/mL decrease in HIV RNA level; the proportion of subjects with ≧ 2 log10 copies/mL decrease in HIV RNA level; change in CD4 cell count on at days 8, 12,
15, and 22, cells/μL) Safety (adverse events): headache, nasal congestion and pruritus |
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Notes | Potential conflicts of interest: some authors are current or past employees of Progenics Pharmaceuticals and may hold stock or stock options in the company Financial support: National Institutes of Health (Public Health Service grant AI066329) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not specified |
Allocation concealment (selection bias) | Unclear risk | This article did not mention |
Selective reporting (reporting bias) | Unclear risk | Unclear |
Other bias | Unclear risk | Unclear |
Blinding | Unclear risk | The objects that were blinded to were not mentioned |
Incomplete outcome data addressed | Unclear risk | Unclear |
AIDS: acquired immune deficiency syndrome; HIV: human immunodeficiency virus; IV: intravenous; N: number of patients