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 |
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| 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 |
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| 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) |
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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 < 400 HIV‐1 RNA copies/mL; change in CD4 cell count on day 8, cells/μL) Safety (adverse events): headache, lymphadenopathy, diarrhoea and fatigue |
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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 | Blinding: the objects that were blinded to were not mentioned |
| Incomplete outcome data addressed | Unclear risk | Unclear |