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. 2014 Jul 26;2014(7):CD008439. doi: 10.1002/14651858.CD008439.pub3

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
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)
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
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)
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