A Phase Ib, Double-Blind, Randomized, Placebo-Controlled Trial in Genotype 1 HCV-Infected Subjects to Determine the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Repeated Doses of TMC649128 Given as Monotherapy and Given in Combination With Pegylated Interferon + Ribavirin

The purpose of this study is to determine in genotype 1 Hepatitis C Virus (HCV)-infected participants, the safety, tolerability, pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and removed from the body over time) and antiviral activity of repeated doses of TMC649128 given as monotherapy and given in combination with pegylated interferon + ribavirin. We assess the pharmacokinetic/pharmacodynamic (how the study medication affects the body) (PK/PD) relationship for antiviral activity, active metabolite and safety of TMC649128 and its metabolites. We determine the short term safety and tolerability of the co-administration of TMC649128 and pegylated interferon + ribavirin during multiple dosing for 14 days in treatment-naive genotype 1 HCV-infected participants. We explore the effect of pegylated interferon + ribavirin on the pharmacokinetics of TMC649128 during the multiple dosing for 14 days in treatment-naive genotype 1 HCV-infected participants. We also assess in a preliminary way the short term antiviral effect of the combination of TMC649128 with pegylated interferon + ribavirin during a 14-day dosing period in treatment-naive genotype 1 HCV-infected participants.

开始日期2011-06-01

申办/合作机构

Tibotec Virco Virology BV

NCT01291563 / Completed临床1期

A Double-blind, Randomized, Placebo- and Active-controlled, Parallel-group Trial to Evaluate the Effect of Single-dose TMC207 on the QT/QTc Interval in Healthy Subjects

The purpose of this study is to evaluate the effect of an 800-mg single dose of TMC207 on the QT/QTc interval in healthy volunteers.

开始日期2011-02-01

申办/合作机构

Tibotec Virco Virology BV

EUCTR2010-021628-84-IE / Not yet recruitingN/A

A randomized, open-label, Phase 3 study of telaprevir administered twice daily or every 8 hours in combination with pegylated interferon alfa-2a and ribavirin in treatment-naïve subjects with genotype 1 chronic hepatitis C virus infection

开始日期2011-01-05

申办/合作机构

Tibotec Virco Virology BV

100 项与 Tibotec Virco Virology BV 相关的临床结果

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0 项与 Tibotec Virco Virology BV 相关的专利（医药）

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项与 Tibotec Virco Virology BV 相关的文献（医药）

2011-09-01·JAIDS Journal of Acquired Immune Deficiency Syndromes3区 · 医学

Effect of Mutations at Position E138 in HIV-1 Reverse Transcriptase on Phenotypic Susceptibility and Virologic Response to Etravirine

3区 · 医学

Article

作者: Daems, Bjorn ; Picchio, Gaston ; Tambuyzer, Lotke ; Vingerhoets, Johan ; Nijs, Steven

The contribution of E138 mutations to etravirine resistance was investigated. Amino acids at position E138 after failure with etravirine in DUET were A (n = 1), G (n = 5), K (n = 3), P (n = 1), Q (n = 5), and V (n = 2). At baseline, only E138A and Q were found at 3.0% and 2.5%, respectively. Virologic response (less than 50 copies/mL) was observed in six of 12 and eight of 10 patients with E138A and E138Q, respectively. Site-directed mutants harboring E138A/G/K/Q/R or S showed etravirine fold change values of 2.9, 2.4, 2.6, 3.0, 3.6, and 2.8, respectively. E138G, K, and Q were added to the existing etravirine-weighted genotypic score including 17 etravirine resistance-associated mutations.

2011-09-01·Physiological Genomics3区 · 生物学

Identification and prioritization ofNUAK1andPPP1CCas positional candidate loci for skeletal muscle strength phenotypes

3区 · 生物学

Article

作者: Huygens, Wim ; De Mars, Gunther ; Vincent, Barbara ; Vlietinck, Robert ; Peeters, Maarten W. ; Wijmenga, Cisca ; Lambrechts, Diether ; Beunen, Gaston ; Aerssens, Jeroen ; Windelinckx, An ; Thomis, Martine A. I.

Muscle strength is an important determinant in elite sports performance as well as in the activities of daily living. Muscle metabolism also plays a role in the genesis, and therefore prevention, of common pathological conditions and chronic diseases. Even though heritability estimates between 31 and 78% suggest a significant genetic component in muscle strength, only a limited number of genes influencing muscle strength have been identified. This study aimed to identify and prioritize positional candidate genes within a skeletal muscle strength quantitative trait locus on chromosome 12q22-23 for follow-up. A two-staged gene-centered fine-mapping approach using 122 single nucleotide polymorphisms (SNPs) in stage 1 identified a familybased association ( n = 500) between several tagSNPs located in the ATPase, Ca2+transporting, cardiac muscle, slow twitch 2 ( ATP2A2; rs3026468), the NUAK family, SNF1-like kinase, 1 ( NUAK1; rs10861553 and rs3741886), and the protein phosphatase 1, catalytic subunit, gamma isoform ( PPP1CC; rs1050587 and rs7901769) genes and knee torque production ( P values up to 0.00092). In stage 2, family-based association tests on additional putatively functional SNPs (e.g., exonic SNPs, SNPs in transcription factor binding sites or in conserved regions) in an enlarged sample ( n = 536; 464 individuals overlap with stage 1) did not identify additional associations with muscle strength characteristics. Further in-depth analyses will be necessary to elucidate the exact role of ATP2A2, PPP1CC, and NUAK1 in muscle strength and to find out which functional polymorphisms are at the base of the interindividual strength differences.

2010-03-27·AIDS2区 · 医学

Etravirine limits the emergence of darunavir and other protease inhibitor resistance-associated mutations in the DUET trials

2区 · 医学

Article

作者: Tambuyzer, Lotke ; Hill, Andrew ; Azijn, Hilde ; Peeters, Monika ; De Meyer, Sandra ; Picchio, Gaston ; Vingerhoets, Johan

Etravirine is a recently approved nonnucleoside reverse transcriptase inhibitor. The ability of etravirine to limit the emergence of resistance to protease inhibitors, and specifically to darunavir, was investigated in the subset of treatment-experienced patients with virologic rebound in the phase III DUET trials. Of those experiencing rebound, fewer etravirine-treated than placebo-treated patients developed mutations associated with resistance to protease inhibitors in general and to darunavir in particular, and more patients in the etravirine than the placebo-group maintained baseline darunavir susceptibility at endpoint.

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药物(靶点)	适应症	全球最高研发状态

R-91767 ( HBV pol )	HIV感染更多	终止
TMC-126 ( HIV-1 protease )	HIV感染更多	终止
TMC-649128 ( NS5B polymerase )	慢性丙型肝炎基因型 1 更多	终止
富马酸贝达喹啉 ( mycobacterial ATP synthase )	肺结核更多	无进展
特拉匹韦 ( NS3/NS4A x cysteine protease )	慢性丙型肝炎基因型 1 更多	无进展