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

Jacobson 2008.

Methods Randomized, double‐blind, placebo‐controlled, dose‐escalating, phase 1b study
Randomization: method not specified
Allocation concealment: unclear
Blinding: the objects that were blinded to were not mentioned
Maximum follow‐up: 58 days
Participants HIV‐infected adults
Subjects were ≧ 18 years of age with HIV‐1 RNA levels 5000 ≧ copies/mL, only CCR5‐tropic (R5) HIV‐1 detectable, CD4+ cell counts ≧ 250 cells/μL with no documented nadir ≧200/μL, and no antiretroviral therapy for ≧ 3 months
Interventions Single IV doses of 0.5 mg/kg (N = 10)
Single IV doses of 2 mg/kg (N = 10)
Single IV doses of 5 mg/kg (N = 10)
Placebo (N = 9)
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 < 400 HIV‐1 RNA copies/mL; change in CD4 cell count on day 8, cells/μL)
Safety (adverse events): headache, lymphadenopathy, diarrhoea and fatigue
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 Blinding: the objects that were blinded to were not mentioned
Incomplete outcome data addressed Unclear risk Unclear