Abstract:
PURPOSE:To characterize the steady-state pharmacokinetic combination of the nonpeptidic protease inhibitor tipranavir (TPV) with ritonavir (RTV) in 95 healthy adult volunteers, a phase 1, single-center, open-label, randomized, parallel-group trial was conducted. METHOD:Participants received 250-mg self-emulsifying drug delivery system (SEDDS) capsules of TPV at doses between 250 mg and 1250 mg twice daily for 11 days, then received one or two RTV 100-mg SEDDS capsules, in addition to the TPV capsules, for the next 21 days. RESULTS:Coadministration of TPV and RTV (TPV/r) resulted in a greater than 20-fold increase in steady-state TPV trough concentrations (Cssmin) as compared with TPV at steady state alone. Mean TPV Cssmin was above a preliminary target threshold of 20 microM with all but one of the RTV-boosted doses; without boosting, none of the TPV-alone doses exceeded the threshold. The average steady-state Cssmin for TPV 500 mg and 750 mg with RTV 100 mg or 200 mg were 20 to 57 times the protein-adjusted TPV IC90R49\CCR418569) for protease inhibitor-resistant HIV-1. An erythromycin breath test, a surrogate marker for cytochrome P450 isoenzyme 3A4 activity, indicated that all TPV/r combinations given provided net inhibition of this isoenzyme. The most frequent treatment-related adverse events were mild gastrointestinal symptoms. CONCLUSION:This phase 1 study demonstrated that RTV-boosted TPV achieves concentrations that are expected to be effective in treating drug-experienced patients.
journal_name
HIV Clin Trialsjournal_title
HIV clinical trialsauthors
MacGregor TR,Sabo JP,Norris SH,Johnson P,Galitz L,McCallister Sdoi
10.1310/RRX7-49ME-27V7-MWWVkeywords:
subject
Has Abstractpub_date
2004-11-01 00:00:00pages
371-82issue
6eissn
1528-4336issn
1945-5771journal_volume
5pub_type
临床试验,杂志文章,随机对照试验abstract:PURPOSE:Recent trials suggest serious toxicity in HIV-associated non-Hodgkin's lymphoma (NHL) with rituximab (R) and chemotherapy (CT), offsetting the benefit of rituximab. METHOD:We retrospectively reviewed experience with CHOP-R vs. CT in 40 patients with HIV-associated diffuse large B-cell lymphoma (DLBCL) diagnose...
journal_title:HIV clinical trials
pub_type: 杂志文章
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journal_title:HIV clinical trials
pub_type: 杂志文章
doi:10.1310/4X0H-UVMJ-BHYW-CPFB
更新日期:2003-09-01 00:00:00
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更新日期:2013-07-01 00:00:00
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journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章
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更新日期:2002-03-01 00:00:00
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journal_title:HIV clinical trials
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更新日期:2018-08-01 00:00:00
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journal_title:HIV clinical trials
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doi:10.1179/1528433614Z.0000000003
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journal_title:HIV clinical trials
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journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章
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更新日期:2002-05-01 00:00:00
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journal_title:HIV clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
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pub_type: 杂志文章
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更新日期:2009-07-01 00:00:00
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journal_title:HIV clinical trials
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更新日期:2013-05-01 00:00:00
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journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1310/brbv-3941-h1pp-ndry
更新日期:2003-03-01 00:00:00
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journal_title:HIV clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1310/hct1505-218
更新日期:2014-09-01 00:00:00
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更新日期:2004-09-01 00:00:00
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更新日期:2006-07-01 00:00:00
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journal_title:HIV clinical trials
pub_type:
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更新日期:2005-01-01 00:00:00
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journal_title:HIV clinical trials
pub_type: 杂志文章,多中心研究
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更新日期:2006-03-01 00:00:00
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journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章
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更新日期:2001-01-01 00:00:00
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journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章
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更新日期:2001-05-01 00:00:00
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pub_type: 杂志文章
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journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章,多中心研究
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更新日期:2002-01-01 00:00:00
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journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
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更新日期:2008-07-01 00:00:00
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journal_title:HIV clinical trials
pub_type: 临床试验,杂志文章
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更新日期:2014-03-01 00:00:00
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pub_type: 杂志文章,meta分析
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更新日期:2010-01-01 00:00:00
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更新日期:2007-07-01 00:00:00