Abstract:
BACKGROUND:Succinylated human serum albumin (Suc-HAS) is a negatively charged neo-glycoprotein that binds to the positively charged V3-loop of HIV-1 gp120, acting as HIV-1-fusion inhibitor in vitro (IC50: 0.5-5.0 microg/ml). Suc-HSA was safe in rats and monkeys, and showed antiretroviral effect in a human-to-mouse model. We evaluated safety and pharmacokinetics of single and multiple doses of Suc-HSA in HIV-1-infected individuals. METHODS:First, six untreated, chronically HIV-1-infected patients were randomized to a single dose of 1 or 10 mg/kg Suc-HSA intravenously. Second, five consecutive daily doses (10 mg/kg, based on the results of the single dose study) were given to four patients. Safety laboratory assessments, Suc-HSA plasma levels, plasma HIV-1 RNA (pVL), and CD4+ T-cell counts were determined. RESULTS:Increase of liver transaminases (grade 1/2) occurred in one of six patients in the single-dose phase and in three of four patients in the multiple-dosing phase. Suc-HSA plasma levels were undetectable 4 h after a single dose of 1 mg/kg. After a dose of 10 mg/kg, plasma levels were more sustained, but declined under the target plasma concentration (10 microg/ml) 12-24 h post-dosing. After multiple dosing, plasma levels reached peak values 2h post-dosing as predicted by our kinetic model. However, trough levels were below the target concentrations. There was no change in pVL or CD4+ T-cell count in either the single- or multiple-dosing phase. CONCLUSIONS:At the chosen dosing regimens, adequate antiviral plasma levels were not maintained, probably because the hepatic clearance was more rapid than expected. This may partially explain the lack of effect on pVL and CD4+ T-cell count. The observed liver transaminase increases prohibit further dose escalation.
journal_name
Antivir Therjournal_title
Antiviral therapyauthors
Vermeulen JN,Meijer DK,Over J,Lange J,Proost JH,Bakker HI,Beljaars L,Wit FW,Prins JMsubject
Has Abstractpub_date
2007-01-01 00:00:00pages
273-8issue
2eissn
1359-6535issn
2040-2058journal_volume
12pub_type
杂志文章,随机对照试验abstract:BACKGROUND:We sought to determine whether markers of systemic inflammation are associated with the presence of moderate/severe obstructive sleep apnea (OSA) and whether this association differs based on HIV and HIV treatment status. METHODS:HIV-uninfected men (HIV-; n=60), HIV-infected men receiving HAART (HIV+/HAART;...
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journal_title:Antiviral therapy
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journal_title:Antiviral therapy
pub_type: 杂志文章
doi:
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journal_title:Antiviral therapy
pub_type: 杂志文章,评审
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更新日期:1999-01-01 00:00:00
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journal_title:Antiviral therapy
pub_type: 杂志文章
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journal_title:Antiviral therapy
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journal_title:Antiviral therapy
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journal_title:Antiviral therapy
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journal_title:Antiviral therapy
pub_type: 杂志文章
doi:
更新日期:2006-01-01 00:00:00
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journal_title:Antiviral therapy
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journal_title:Antiviral therapy
pub_type: 杂志文章
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更新日期:2013-01-01 00:00:00
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journal_title:Antiviral therapy
pub_type: 杂志文章
doi:
更新日期:2005-01-01 00:00:00
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journal_title:Antiviral therapy
pub_type: 杂志文章
doi:
更新日期:2001-03-01 00:00:00
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journal_title:Antiviral therapy
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doi:
更新日期:2000-09-01 00:00:00
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pub_type: 杂志文章,多中心研究
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