A5011950226- HIV/AIDS drug development and treatment
- Hepatitis C virus research
- HIV Research and Treatment
- Liver Disease Diagnosis and Treatment
- Hepatitis B Virus Studies
- HIV/AIDS Research and Interventions
- Respiratory viral infections research
- Systemic Lupus Erythematosus Research
- Chronic Lymphocytic Leukemia Research
- HIV-related health complications and treatments
- Pneumonia and Respiratory Infections
- Immune Cell Function and Interaction
- Cytomegalovirus and herpesvirus research
- Liver Disease and Transplantation
- Pneumocystis jirovecii pneumonia detection and treatment
- Chemotherapy-related skin toxicity
- Neonatal Respiratory Health Research
- Pharmacological Effects and Toxicity Studies
- Multiple and Secondary Primary Cancers
- Emergency and Acute Care Studies
- Sepsis Diagnosis and Treatment
- Drug-Induced Hepatotoxicity and Protection
- Drug-Induced Ocular Toxicity
- Polish Law and Legal System
- Health Systems, Economic Evaluations, Quality of Life
Janssen (United States)
2012-2023
Indiana University – Purdue University Indianapolis
2016
Orlando Immunology Center
2015
Texas Liver Institute
2015
The University of Texas Health Science Center at San Antonio
2015
Janssen (Belgium)
2013
Sapporo Kosei General Hospital
2013
Drexel University
2003-2005
Emory University
2003
Hahnemann University Hospital
2001
ContextDespite suppressive treatment with highly active antiretroviral therapy (HAART), replication-competent virus can still be isolated from peripheral blood mononuclear cells and genital of many individuals receiving HAART.ObjectiveTo determine whether free virion RNA detected in the plasma and/or tract fluids patients HAART.DesignProspective cohort study conducted November 1998 to May 1999.SettingAcademic medical center.PatientsHuman immunodeficiency 1–infected (20 men 2 women) shown our...
Effective antiviral therapy is essential for achieving sustained virological response (SVR) in hepatitis C virus (HCV)‐infected patients. The phase 2 COSMOS study reported high SVR rates treatment‐naive and prior null‐responder HCV genotype (GT) 1‐infected patients receiving simeprevir+sofosbuvir±ribavirin 12 or 24 weeks. OPTIMIST‐1 (NCT02114177) was a multicenter, randomized, open‐label assessing the efficacy safety of 8 weeks simeprevir+sofosbuvir GT1‐infected treatment‐experienced without...
Hepatitis C virus (HCV)–infected patients with cirrhosis are historically a difficult‐to‐treat population and at risk of hepatic decompensation. In the phase 2 COSMOS study that evaluated simeprevir (HCV NS3/4A protease inhibitor) + sofosbuvir nucleotide analogue NS5B polymerase ± ribavirin for 12 or 24 weeks in HCV genotype (GT)1–infected patients, high rates sustained virologic response after planned end treatment (SVR12) were achieved, including (METAVIR score F4). This 3, open‐label,...
Background Durable efficacy and long-term safety of antiretroviral therapy are important goals in the management treatment-experienced patients. The 96-week non-nucleoside reverse transcriptase inhibitor (NNRTI) etravirine were evaluated Phase III DUET trials. Methods HIV type-1-infected adults with viral loads >5,000 copies/ml NNRTI protease resistance randomized to receive 200 mg or placebo, each twice daily combination a background regimen darunavir/ritonavir daily,...
Respiratory syncytial virus (RSV) infection is the leading cause of infant hospitalizations and mortality. Lumicitabine, an oral nucleoside analog was studied for treatment RSV. The phase 1b 2b studies reported here assessed safety, pharmacokinetics, pharmacodynamics lumicitabine in infants/neonates hospitalized with In study, infants (≥1 to ≤12 months) neonates (<28 days) received a single-ascending or multiple-ascending doses (single loading dose [LD] then 9 maintenance [MD] lumicitabine,...
Background & AimsWe performed an open-label, multicenter, phase 3 study of the safety and efficacy twice-daily telaprevir in treatment-naive patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those cirrhosis.MethodsPatients were randomly assigned to groups treated 1125 mg twice daily or 750 every 8 hours plus peginterferon alfa-2a ribavirin for 12 weeks; then alone weeks if their level HCV RNA at week 4 was <25 IU/mL 36 higher. The primary objective demonstrate...
Abstract Background The hospitalized acute respiratory tract infection (HARTI) study used the Respiratory Intensity and Impact Questionnaire (RiiQ™) Symptom Scale, derived from FluiiQ™, to assess compare burden of symptoms for patients with influenza, syncytial virus (RSV), human metapneumovirus (hMPV) infection, or without core risk factors (CRF) (age ≥65; chronic heart, renal, obstructive pulmonary disease; asthma). Methods This was a prospective cohort in adult (40 centers, 12 countries)...
Respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and influenza are respiratory pathogens leading to hospitalization in adults. Our understanding of the disease burden is limited data from single-center or 1-season studies elderly patients. The HARTI study allows comparison risk factors for progression severe medical resources utilization (MRU) during post-hospitalization adults diagnosed with influenza, RSV, hMPV.This was a prospective global hospitalized acute tract...
Human immunodeficiency virus-specific CD8(+) T cells are highly sensitive to spontaneous and CD95/Fas-induced apoptosis, this sensitivity may impair their ability control HIV infection. To elucidate the mechanism behind sensitivity, in study we examined levels of antiapoptotic molecules Bcl-2 Bcl-x(L) HIV-specific from HIV-infected individuals. expression was markedly decreased compared with CMV-specific total individuals as well healthy donors. cell inversely correlated apoptosis also had...
Background A pharmacokinetic trial was conducted to evaluate the potential for once-daily etravirine in anti-retroviral regimens without and with darunavir/ritonavir. Methods During this multicentre, open-label, Phase IIa trial, treatment-naive patients aged ≥18 years HIV type-1 (HIV-1) received 400 mg once daily tenofovir disoproxil fumarate/emtricitabine 300/200 from days 1–14; on 15–28, darunavir/ritonavir 800/100 added. On day 29, discontinued continued other medications 42. Serial blood...
Background Rilpivirine and efavirenz share metabolic pathways (CYP3A), potentially leading to drug–drug interactions. We report the pharmacokinetics, ex vivo antiviral activity safety of rilpivirine, following treatment. Methods HIV-negative adults received in fixed sequence: treatment A (rilpivirine 25 mg once daily for 14 days, followed by a washout), B (efavirenz 600 days), immediately C 28 days). pharmacokinetic profiles were determined on days 1 1, 14, 21 C. Ex was measured treatments...
ABSTRACT Hepatitis C virus (HCV) antibody is present in most patients enrolled methadone maintenance programs. Therefore, interactions between the HCV protease inhibitor telaprevir and were investigated. The pharmacokinetics of R- S -methadone measured after administration alone 7 days (750 mg every 8 h [q8h]) coadministration HCV-negative subjects on stable, individualized therapy. Unbound R was predose plasma samples before during coadministration. Safety symptoms opioid withdrawal...
Coinfection with human immunodeficiency virus (HIV) and hepatitis C (HCV) may require treatment an HIV non-nucleoside reverse transcriptase inhibitor (NNRTI), for example, rilpivirine or etravirine, HCV direct-acting antiviral drug such as telaprevir. In a two-panel, two-way, crossover study, healthy volunteers were randomized to receive etravirine 200 mg twice daily ± telaprevir 750 every 8 hours 25 once hours. Pharmacokinetic assessments conducted each at steady-state when given alone...
Baseline homeostasis model assessment-estimated insulin resistance (HOMA-IR), a marker for resistance, has been associated with poor virologic response to peginterferon alpha/ribavirin (PR) in chronic hepatitis C. We evaluated the association between baseline HOMA-IR and pretreatment factors on sustained (SVR) telaprevir (TVR) genotype 1 patients C prior peginterferon/ribavirin treatment failure. Patients were randomized 12 weeks of TVR (750 mg q8h) plus (180 μg/week) ribavirin (1,000-1,200...
Objectives The aim of the study was to investigate frequency and severity adverse events ( AEs ) laboratory abnormalities interest over 96 weeks treatment with etravirine or placebo in pooled TMC125 DUET (Demonstrate Undetectable viral load patients Experienced ARV Therapy) trials. Methods Treatment‐experienced, HIV ‐1‐infected randomly received 200 mg twice a day (bid) placebo, plus background regimen. neuropsychiatric, rash, hepatic lipid were analysed; frequencies also adjusted for total...
Etravirine, a nonnucleoside reverse transcriptase inhibitor, was provided through an international early access program (EAP) prior to regulatory approval.The Phase III, nonrandomized, open-label EAP investigated etravirine 200 mg twice daily plus background regimen (BR) in patients who had failed multiple antiretroviral regimens. Efficacy and safety are reported for HIV-infected adults from the United States week 48, including subgroups receiving +/- darunavir/ritonavir and/or...
Abstract The prevalence of susceptibility to etravirine was investigated among clinical samples submitted for routine testing in the United States using two separate weighted genotypic scoring systems. presence mutations and by phenotype from HIV-1-infected patients, Monogram Biosciences resistance between June 2008 2009, were analyzed. Susceptibility genotype determined Tibotec etravirine-weighted systems, with scores ≤3 ≤2, respectively, indicating full susceptibility. PhenoSense HIV...
Aims: The ADVANCE study showed that telaprevir (TVR, T) every 8 hours (q8h) combined with peginterferon alfa-2a (P) and ribavirin (R) had superior efficacy to PR alone. Reported here are results from OPTIMIZE, a Phase III, randomized, open-label, international, non-inferiority comparing twice daily (bid) vs. q8h TVR (NCT01241760).