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 |
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| 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 |
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| 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) |
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| 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 |
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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 |