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

Jacobson 2010a.

Methods Randomized, double‐blind, placebo‐controlled, phase 2a study
Randomization: method not specified
Allocation concealment: unclear
Blinding: the objects that were blinded to were not mentioned
Maximum follow‐up: 59 days
Participants Adults with asymptomatic HIV‐1 infection
Entry criteria included age of ≧ 18 years, plasma HIV‐1 RNA level of ≧ 5000 copies/mL, CD4+ lymphocyte count of ≧ 300 cells/μL with no documented count of ≦ 250 cells/μL, no antiretroviral therapy for ≧ 12 weeks, no history of AIDS‐defining illness, and only R5 HIV‐1 detectable
Interventions 162 mg of PRO 140 on days 1, 8, and 15 (162 mg weekly) (N = 11)
324 mg of PRO 140 on days 1 and 15 and placebo on day 8 (324 mg biweekly) (N = 12)
324 mg of PRO 140 on days 1, 8, and 15 (324 mg weekly) (N = 11)
Placebo on days 1, 8, and 15 (Placebo) (N = 10)
Outcomes Antiviral effects (mean log10 reductions in HIV‐1 RNA level at virologic nadir, Day 22 log10 change in HIV‐1 RNA level, number of subjects with HIV‐1 RNA decrease, number of subjects with < 400 copies/mL HIV‐1 RNA, change in CD4+ cell count, cells/μL, at day 8, day 15, day 22)
Safety (adverse events): diarrhoea, headache, lymphadenopathy, hypertension
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