A Multicenter, Single Arm, Open-Label Study of the Once Daily Combination of Etravirine and Darunavir/Ritonavir As Dual Therapy in Early Treatment-Experienced Patients

This study is a Phase II single arm, open-label, multicenter, study of 50 human immunodeficiency virus-1 (HIV) infected adult patients, all of whom will receive etravirine (ETR) 400mg and DRV/r 800/100mg each given orally once daily. This trial is designed to evaluate the efficacy of the aforementioned ARV regimen, as measured by the percentage of patients with HIV RNA <50 copies/mL at 48 weeks, in early treatment-experienced HIV-infected patients. In addition to general safety parameter measurements, this trial will also assess changes in metabolic, inflammatory, immune restoration, and bone markers. Screening will occur over a 6-week period. The primary endpoint will be assessed at Week 48, and the treatment period is 48 weeks. The end of study endpoint will be met by either completing the Week 48 visit, or by early termination from the study for any reason.

Start Date01 May 2010

Sponsor / Collaborator

Tibotec LLC

[+1]

NCT00993148 / CompletedPhase 2IIT

Maraviroc Plus Darunavir/Ritonavir Study for Treatment-Naïve Patients Infected With R5-tropic HIV-1 Based on Enhanced Sensitivity Trofile

The objective of this study is to evaluate the safety and efficacy of a novel combination antiretroviral therapy regimen consisting of maraviroc plus darunavir/ritonavir in treatment-naive patients infected with R5-tropic HIV-1. The hypothesis is that in treatment-naive subjects infected with R5-tropic HIV-1, combination antiretroviral therapy with maraviroc plus darunavir/ritonavir is well tolerated and efficacious.

Start Date01 May 2010

Sponsor / Collaborator

Northwestern University

[+2]

NCT01045369 / CompletedPhase 4

A Phase IV 48 Week, Open Label, Pilot Study of Kaletra and Intelence Tablets in Naive Subjects

The purpose of this study is to see if using a combination of other drug classes, like the ones that Kaletra® and Intelence™ belong to, can still help reduce the amount of HIV in your blood. Using Kaletra® and Intelence™ without other drugs is not approved by the FDA and so their use in this study is experimental.

Start Date01 Jan 2010

Sponsor / Collaborator

Therapeutic Concepts LLC.

[+2]

100 Clinical Results associated with Tibotec LLC

0 Patents (Medical) associated with Tibotec LLC

278

Literatures (Medical) associated with Tibotec LLC

01 Nov 2014·Journal of HepatologyQ1 · MEDICINE

Sustained virological response with telaprevir in 1078 patients with advanced hepatitis C: The international telaprevir access program

Q1 · MEDICINE

Article

Author: Streinu-Cercel, Adrian ; Lonjon-Domanec, Isabelle ; Wedemeyer, Heiner ; Iraqi, Wafae ; Strasser, Simone ; Verheyen, Anke ; Urbanek, Petr ; Colombo, Massimo ; Abrao Ferreira, Paulo ; Hill, Andrew ; Moreno, Christophe ; Fernández, Inmaculada ; DeMasi, Ralph ; Abdurakmonov, Djamal

BACKGROUND & AIMSThere is little information regarding the extent to which difficult to cure patients with advanced liver fibrosis, due to hepatitis C virus genotype-1 (HCV-1) can successfully and safely be treated with triple therapy with telaprevir (TVR), pegylated interferon alpha (P) and ribavirin (R). In the TVR early access program HEP3002 we aimed to explore treatment safety and efficacy, and identify predictors of sustained virological response at week 24 (SVR24).METHODS1078 patients with bridging fibrosis (n=552) or cirrhosis (n=526) diagnosed by either liver biopsy or non-invasive markers, with compensated bone marrow (neutrophils >1500/mm(3), Hb >12/13 g/dl) and liver function (Albumin >3.3g/dl, Platelets >90,000/ml) received TVR PR for 12 weeks, followed by a PR tail according to label.RESULTSOverall, 614 (57%) achieved SVR24 by intention-to-treat analysis. The SVR24 rate was 68% in 221 treatment naïve patients (62.8% F4), 72% in 356 prior relapsers (64.4% F4), 55% in 139 partial responders (53.2% F4), and 34% in 294 null responders (28.6% F4). The SVR24 rate to response-guided therapy (24 weeks treatment duration if undetectable viremia at weeks 4 and 12) was 84% in 222 naïve/relapser F3 patients. Independent predictors of response were: (A) F3 (odds ratio (OR)=1.51, 95% CI 1.31-2.00, p=0.005), (B) subtype 1b (OR=1.63, 95% CI 1.18-2.24, p=0.0029), (C) alpha-fetoprotein <10 ng/ml (OR=2.50, 95% CI 1.87-3.36, p<0.0001) and (D) any prior response other than null (OR=3.29, 95% CI 2.40-4.52, p<0.0001). SVR24 rose for patients who had more of these predictive factors: 6/32 (19%) for none, 38/139 (27%) for 1, 129/260 (50%) for 2, 202/329 (61%) for 3, and 194/235 (83%) for 4 factors. Grade 2-4 treatment-related adverse events (AE) were experienced by 719 (67%) patients; 169 (16%) discontinued therapy for AE and 7 (0.6%) died during the PR tail.CONCLUSIONSNaïve and experienced patients with advanced fibrosis or cirrhosis due to HCV-1 who have compensated bone marrow and liver function, can effectively and safely be treated by TVR triple therapy. Baseline predictors of outcome have been identified to optimize pre-treatment counselling.

01 Dec 2013·Journal of CheminformaticsQ2 · CHEMISTRY

Benchmarking of protein descriptor sets in proteochemometric modeling (part 1): comparative study of 13 amino acid descriptor sets

Q2 · CHEMISTRY

ArticleOA

Author: Jörg K. Wegner ; Remco F. Swier ; Gerard J. P. van Westen ; Andreas Bender ; Adriaan P. IJzerman ; Herman W. T. van Vlijmen

BACKGROUNDWhile a large body of work exists on comparing and benchmarking of descriptors of molecular structures, a similar comparison of protein descriptor sets is lacking. Hence, in the current work a total of 13 different protein descriptor sets have been compared with respect to their behavior in perceiving similarities between amino acids. The descriptor sets included in the study are Z-scales (3 variants), VHSE, T-scales, ST-scales, MS-WHIM, FASGAI and BLOSUM, and a novel protein descriptor set termed ProtFP (4 variants). We investigate to which extent descriptor sets show collinear as well as orthogonal behavior via principal component analysis (PCA).RESULTSIn describing amino acid similarities, MSWHIM, T-scales and ST-scales show related behavior, as do the VHSE, FASGAI, and ProtFP (PCA3) descriptor sets. Conversely, the ProtFP (PCA5), ProtFP (PCA8), Z-Scales (Binned), and BLOSUM descriptor sets show behavior that is distinct from one another as well as both of the clusters above. Generally, the use of more principal components (>3 per amino acid, per descriptor) leads to a significant differences in the way amino acids are described, despite that the later principal components capture less variation per component of the original input data.CONCLUSIONIn this work a comparison is provided of how similar (and differently) currently available amino acids descriptor sets behave when converting structure to property space. The results obtained enable molecular modelers to select suitable amino acid descriptor sets for structure-activity analyses, e.g. those showing complementary behavior.

01 Dec 2013·Virology JournalQ3 · MEDICINE

Quantitative prediction of integrase inhibitor resistance from genotype through consensus linear regression modeling

Q3 · MEDICINE

ArticleOA

Author: Liesbeth Van Wesenbeeck ; Yvan Verlinden ; Herman van Vlijmen ; Ann Verheyen ; Elke Van Craenenbroeck ; Koen Van der Borght ; Maxim Feyaerts

BACKGROUNDIntegrase inhibitors (INI) form a new drug class in the treatment of HIV-1 patients. We developed a linear regression modeling approach to make a quantitative raltegravir (RAL) resistance phenotype prediction, as Fold Change in IC50 against a wild type virus, from mutations in the integrase genotype.METHODSWe developed a clonal genotype-phenotype database with 991 clones from 153 clinical isolates of INI naïve and RAL treated patients, and 28 site-directed mutants.We did the development of the RAL linear regression model in two stages, employing a genetic algorithm (GA) to select integrase mutations by consensus. First, we ran multiple GAs to generate first order linear regression models (GA models) that were stochastically optimized to reach a goal R2 accuracy, and consisted of a fixed-length subset of integrase mutations to estimate INI resistance. Secondly, we derived a consensus linear regression model in a forward stepwise regression procedure, considering integrase mutations or mutation pairs by descending prevalence in the GA models.RESULTSThe most frequently occurring mutations in the GA models were 92Q, 97A, 143R and 155H (all 100%), 143G (90%), 148H/R (89%), 148K (88%), 151I (81%), 121Y (75%), 143C (72%), and 74M (69%). The RAL second order model contained 30 single mutations and five mutation pairs (p < 0.01): 143C/R&97A, 155H&97A/151I and 74M&151I. The R2 performance of this model on the clonal training data was 0.97, and 0.78 on an unseen population genotype-phenotype dataset of 171 clinical isolates from RAL treated and INI naïve patients.CONCLUSIONSWe describe a systematic approach to derive a model for predicting INI resistance from a limited amount of clonal samples. Our RAL second order model is made available as an Additional file for calculating a resistance phenotype as the sum of integrase mutations and mutation pairs.

News (Medical) associated with Tibotec LLC

29 Oct 2008

·www.biospace.com

Sequella, Inc. Presents Data on Synergy Between Investigational New TB Drugs SQ109 and TMC207

Study results to be presented at 2008 ICAAC/IDSA Joint Meeting ROCKVILLE, Md., Oct. 28 /PRNewswire/ -- Sequella, Inc., a clinical-stage biopharmaceutical company focused on commercializing products to treat infectious diseases of epidemic potential, announces the successful demonstration of synergistic activities and improvement of minimal inhibitory concentration (MIC) resulting from in vitro combination studies of Sequella lead TB drug candidate, SQ109, and Tibotec's lead TB drug candidate, TMC207. Both drug candidates are currently undergoing human clinical studies. Results from these studies were presented on October 28th at the Interscience Conference on Anti-Microbial Agents and Chemotherapeutics (ICAAC) and Infectious Disease Society of America (IDSA) joint meeting in Washington, DC. The collaboration between Sequella and Tibotec was designed to investigate in vitro interactions of SQ109 for synergistic, additive, or antagonistic activity in the presence of TMC207, using a number of clinical and laboratory strains of both drug sensitive and drug resistant M. tuberculosis (MTB). In vitro interactions investigated included synergy studies, rate of killing, post antibiotic effect and intracellular activity against MTB in macrophages. There were no antagonistic activities observed in any combination studies. SQ109 and TMC207 in combination were either synergistic or additive with the various MTB strains and showed increased rate of killing, enhanced post antibiotic effect and intracellular killing activity. Results showed that the SQ109 and TMC207 drug combination was extraordinary potent, with greater than 90% kill of MTB as early as 1 day after drug combination exposure. Dr. Carol Nacy, CEO of Sequella said, "We are very pleased to be collaborating with Tibotec, a world renowned product development organization, and we look forward to our continuing partnership to examine these important drug synergies in animal models of TB." The next step of the collaboration will be to complete a series of in vivo studies in animal models of TB, currently underway. About SQ109 The company's lead drug candidate, SQ109, completing Phase I clinical trials, is a new diamine antibiotic that could replace one or more of the current first-line anti-tuberculosis drugs to simplify or shorten therapy. SQ109 was granted U.S. FDA Fast Track and FDA/EMEA Orphan Drug Designation in 2007. About Sequella Sequella is a clinical stage biopharmaceutical company focused on commercializing improved treatments for infectious diseases of epidemic potential. The company leverages its global influence, R&D platforms and infectious disease expertise to proactively address emerging health threats. Through focused execution, clear commercialization pathways, and strategic partnerships, Sequella intends to commercialize a broad product portfolio designed to treat global health threats with significant market opportunity. Forward-Looking Statement This press release contains forward-looking statements that are subject to risks and uncertainties, and includes statements that are not historical facts. Actual results could differ significantly from results discussed. Sequella disclaims any intent or obligation to update forward-looking statements, except as required by law. CONTACT: Alicia Moran, +1-410-991-7027, for Sequella, Inc. Web site:

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Drug(Targets)	Indications	Global Highest Phase

Rilpivirine Hydrochloride ( RT )	HIV Infections More	Pending
Darunavir ( HIV-1 protease )	HIV Infections More	Pending

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