Clinical Trials Sponsored by Tibotec, Inc

Total 35670 results

Tibotec Pharmaceuticals, Ireland

Completed

TMC125-TiDP35-C213: Safety and Antiviral Activity of Etravirine (TMC125) in Treatment-Experienced, HIV Infected Children and Adolescents

HIV-1

United States, France, Spain, Portugal, Canada, United Kingdom, South Africa, Argentina, Brazil, Puerto Rico, Thailand, Netherlands, Romania
Tibotec Pharmaceuticals, Ireland

Completed

A Study to Assess the Long-term Safety and Tolerability of TMC114/Rtv in HIV-1 Infected Participants After Rolling-over From Other TMC114 Trials

HIV

United Kingdom, Germany, Denmark, Belgium, Austria, Poland, Australia, Russian Federation
Tibotec Pharmaceuticals, Ireland

Completed

TMC125-C206: A Phase III Study to Investigate the Efficacy, Tolerability and Safety of TMC125 as Part of an Antiretroviral Regimen, Including TMC114/Ritonavir and an Investigator-selected Optimized Background, in HIV-1 Infected Patients With Limited to no Treatment Options.

HIV

United States, France, Argentina, Chile, Mexico, Costa Rica, Panama, Brazil, Puerto Rico, Thailand
Tibotec Pharmaceuticals, Ireland

Completed

A Study of TMC435 in Combination With Pegylated Interferon Alp\Fa-2a and Ribavirin in Patients Infected With Genotype 1 Hepatitis C Virus Who Never Received Treatment (PILLAR)

Hepatitis C

United States, Australia, France, Belgium, Germany, Spain, Denmark, Canada, New Zealand, Russian Federation, Austria, Poland, Norway
Tibotec Pharmaceuticals, Ireland

Completed

A Safety and Effectiveness Study of TMC435 in Chronic, Genotype 1, Hepatitis C Patients Who Failed to Previous Standard Treatment (ASPIRE)

Hepatitis C

United States, Australia, France, United Kingdom, Belgium, Germany, Israel, Portugal, Canada, New Zealand, Russian Federation, Austria, Poland, Norway
Tibotec Pharmaceuticals, Ireland

Completed

A Study of TMC435350 Administered With or Without Standard of Care Therapy in Participants With Genotype 1 Hepatitis C Virus Infection

Hepatitis C, Chronic

France, United Kingdom, Belgium, Germany, Poland, Netherlands
Tibotec Pharmaceuticals, Ireland

Completed

An Open-label Trial With TMC125 in Patients Who Have Virologically Failed in a DUET Trial (TMC125-C206 or TMC125-C216).

HIV-1

United States, Canada, France, Belgium, Germany, Spain, Argentina, Chile, Panama, Brazil, Puerto Rico, Thailand, Mexico, Australia
Tibotec Pharmaceuticals, Ireland

Completed

TMC114-TiDP3-C182 - A Study to Compare the Oral Bioavailability of a 800 mg Prototype Tablet Formulation of Darunivar (DRV) to That of the 400 mg Commercial Tablet Formulation in the Presence of Low Dose Ritonavir, Under Fasted and Fed Conditions

HIV Infections
Tibotec Pharmaceuticals, Ireland

Completed

TMC435-TiDP16-C117: The Effect of TMC435 on the Results of Electrocardiograms (Electric Recording of the Heart) in Healthy Volunteers

Hepatitis C
Tibotec Pharmaceuticals, Ireland

Completed

TMC435-TiDP16-C119 - A Study Comparing 2 New Capsule Formulations of TMC435 to an Established Capsule Formulation and Evaluating the Respective Blood Levels of TMC435 Following Single Dose Administration

Hepatitis C Virus
Tibotec Pharmaceuticals, Ireland

Completed

A Study to Compare Effectiveness and Safety of Darunavir/Ritonavir (DRV/Rtv) 800mg/100mg Once Daily Versus DRV/Rtv 600mg/100mg Twice Daily in Early Treatment-Experienced HIV-1 Infected Patients (ODIN) (ODIN)

Human Immunodeficiency Virus - Type 1

United States, France, United Kingdom, Germany, Taiwan, Spain, Argentina, Chile, Malaysia, Panama, Romania, South Africa, Thailand, Brazil, Puerto Rico, Austria, Hungary, Australia, Guatemala
Tibotec Pharmaceuticals, Ireland

Completed

TMC435-TiDP16-C114 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and the Antiretroviral Agents TMC278 and Tenofovir

Hepatitis C Virus
Tibotec Pharmaceuticals, Ireland

Completed

TMC435-TiDP16-C123 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and the Antiretroviral Agents Efavirenz and Raltegravir

Hepatitis C Virus

Germany
Tibotec Pharmaceuticals, Ireland

Completed

A Study in Healthy Participants Investigating the Effect of TMC435 on the Pharmacokinetics of Immunosuppressants Cyclosporine and Tacrolimus

Hepatitis C Virus

Belgium
Tibotec Pharmaceuticals, Ireland

Completed

TMC114-TiDP29-C169: Bioavailability and Pharmacokinetics Trial Comparing Darunavir Pediatric Suspension Formulation to Current Darunavir Tablet

Pharmacokinetics
Tibotec Pharmaceuticals, Ireland

Completed

TMC125-C227: A Phase II Randomized, Active-Controlled, Open Label Trial to Investigate the Efficacy and Tolerability of TMC125 in HIV-1 Infected Subjects, Who Are PI-Naive and With Documented Genotypic Evidence of NNRTI Resistance From Previous NNRTI Use

HIV Infection
Tibotec Pharmaceuticals, Ireland

Completed

Innovation-TiFP4-C101: A Study to Evaluate the Pharmacokinetics of TMC114 and TMC41629 After a Single Oral Dose of 2 Controlled-release Coformulations as Compared to an Immediate-release Coformulation of TMC114/TMC41629

HIV-I
Tibotec Pharmaceuticals, Ireland

Completed

TMC435-TiDP16-C107: This Study Measures the (Possible) Influence of TMC435 on the Activity of a Selected Set of Drug-degrading Proteins by Measuring the Blood Levels of Drugs That Have Been Taken Together With TMC435 and That Are Known to be Specifically Degraded by These Drug-degrading Proteins.

Hepatitis C | Viruses
Tibotec Pharmaceuticals, Ireland

Completed

TMC125-C223: TMC125 in HIV-1 Infected Subjects

HIV Infection
Tibotec Pharmaceuticals, Ireland

Terminated

TMC114-C227: A Study to Evaluate the Effectiveness and Safety of TMC114 (Darunavir) With a Low Dose of Ritonavir as Monotherapy (no Other Anti-HIV Drugs Will be Given) in Patients Who Have Never Been Treated With Antiretrovirals (Anti-HIV Drugs) Previously

HIV Infections
Miltenyi Biotec, Inc.

Terminated

Stem Cell Implantation in Patients Undergoing CABG

Coronary Artery Disease | Ischemic Cardiomyopathy

United States
Tibotec Pharmaceuticals, Ireland

Withdrawn

PEPI-TiDP23-C104 is a First in Human Study With a Single Dose Escalation Part and a Multiple Dosing Part for Compounds TMC589337 and TMC589354.

HIV Infections

Netherlands
Tibotec Pharmaceuticals, Ireland

Completed

TMC114-C202: A Study of Safety, Efficacy, and Tolerability of TMC114 and Low Dose Ritonavir in HIV-1 Infected Patients

HIV Infections

United States, Argentina
Tibotec Pharmaceuticals, Ireland

Completed

The TMC125-C214 Study Provides Early Access to TMC125 for HIV-1 Infected Patients Who Have Failed Multiple Antiretroviral Regimens and Will Also Gather Information on the Long-term Safety and Tolerability of TMC125 Combined With Other Antiretroviral Drugs

HIV-1

United States, Belgium, Germany, Taiwan, Spain, Mexico, Turkey, Canada, Netherlands, Denmark, Greece, Sweden, Korea, Republic of, Russian Federation, Puerto Rico, Luxembourg
Tibotec Pharmaceuticals, Ireland

Completed

A Study to Assess the Anti-viral Activity, Safety, Tolerability and Pharmacokinetics of TMC435350 in Participants Infected With Hepatitis C-Virus (HCV)

Hepatitis C

Belgium, Germany, Thailand
Tibotec Pharmaceuticals, Ireland

Completed

A Study of TMC278 in Human Immunodeficiency Virus Type 1 Infected Patients, Who Are Not Treated With Antiretroviral Medicines

Human Immunodeficiency Virus Type 1

United States, France, United Kingdom, China, Germany, South Africa, Russian Federation, Argentina, Brazil, Puerto Rico, Austria, Thailand, Mexico, Uganda
Tibotec Pharmaceuticals, Ireland

Completed

An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects.

HIV Infection

United States, Australia, France, United Kingdom, Germany, Spain, Belgium, Portugal, Canada, Argentina, Brazil, Austria, Hungary
Tibotec Pharmaceuticals, Ireland

Completed

TMC435-TiDP16-C126 - Trial to Investigate the Effect of Severe Renal Impairment on the Pharmacokinetics and Safety of TMC435

Hepatitis C Virus

Czech Republic
Tibotec Pharmaceuticals, Ireland

Completed

A Study of Drug-drug Interaction Between Ritonavir and TMC435350 in Healthy Volunteers

Healthy

Belgium
Tibotec Pharmaceuticals, Ireland

Completed

A Study to Determine the Antiviral Activity of TMC310911 When Administered With Ritonavir in Treatment-Naive Human Immunodeficiency Virus - Type 1 (HIV-1) Infected Patients

Human Immunodeficiency Virus Type 1

Germany
Tibotec Pharmaceuticals, Ireland

Completed

TMC647055HPC1001 - First-in-human Trial to Examine Safety, Tolerability and Pharmacokinetics (How the Drug is Absorbed Into the Bloodstream) of Increasing Single Oral Doses and of Increasing Repeated Oral Doses of TMC647055 in Healthy Volunteers and in Hepatitis C Virus Infected Patients

Hepatitis C

Belgium
Tibotec Pharmaceuticals, Ireland

Completed

A Study in Healthy Female Participants Investigating the Effect of TMC435 on the Pharmacokinetics of the Synthetic Hormones of the Oral Contraceptive Ovysmen

Hepatitis C Virus

Belgium
Tibotec Pharmaceuticals, Ireland

Completed

TMC125HIV1083 - Swallowability of Uncoated 200 mg Etravirine Tablets in HIV-1 Infected Patients

HIV-Infections
Tibotec Pharmaceuticals, Ireland

Completed

TMC435-TiDP16-C108 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and Digoxin and Between TMC435 and Rosuvastatin

Hepatitis C Virus
Tibotec Pharmaceuticals, Ireland

Completed

TMC435-TiDP16-C116 - Relative Bioavailability and Food Effect Study

Hepatitis C
Tibotec Pharmaceuticals, Ireland

Completed

TMC125IFD1001 - Drug-Drug Interaction of Etravirine With Telaprevir and TMC278 With Telaprevir.

Hepatitis C | HIV

Belgium
Tibotec Pharmaceuticals, Ireland

Completed

TMC125-C216: A Phase III Study to Investigate the Efficacy, Tolerability and Safety of TMC125 as Part of an Antiretroviral Regimen, Including TMC114/Ritonavir and an Investigator-selected Optimized Background, in HIV-1 Infected Patients With Limited to no Treatment Options.

HIV
Tibotec Pharmaceuticals, Ireland

Completed

TMC114-C209: A Study of Safety of TMC114 With Low Dose Ritonavir (RTV) and Other Antiretrovirals in Experienced HIV-1 Infected Patients With Limited or no Treatment Options

HIV Infections
Tibotec Pharmaceuticals, Ireland

Completed

TMC278-TiDP38-C145: A Bioavailability Study in Healthy Adult Volunteers to Evaluate 3 Pediatric Formulations of TMC278 (a Solution, a Suspension, and Granules) Compared to an Adult Tablet Formulation

Pharmacokinetics | Bioavailability | HIV-1
Tibotec Pharmaceuticals, Ireland

Completed

TMC278-TiDP6-C152: A Study to Assess the Effects of TMC278 and Efavirenz (EFV) on the QT/QTc Interval (Heart Conduction and Heart Rhythm) in Healthy Volunteers.

Human Volunteers
Tibotec Pharmaceuticals, Ireland

Completed

TMC125-TiDP2-C197: A Phase I Trial to Investigate the Pharmacokinetic Interaction Between Lopinavir/Ritonavir and TMC125 Both at Steady-state in Healthy Volunteers.

HIV
Tibotec Pharmaceuticals, Ireland

Completed

TMC114-TiDP3-C181: Study to Assess the Pharmacokinetics of Darunavir (DRV) With Different Doses of Ritonavir in Healthy Volunteers.

HIV | AIDS
Tibotec Pharmaceuticals, Ireland

Completed

TMC125-TiDP2-C188: A Phase I, Open-label Trial to Investigate the Pharmacokinetic Effect of Multiple-dose TMC125 on Buprenorphine and Norbuprenorphine Administered in HIV-negative Patients on Stable Buprenorphine/Naloxone Maintenance Therapy.

HIV | Pharmacokinetics
Tibotec Pharmaceuticals, Ireland

Completed

TMC435350-TiDP16-C101 - A Study to Examine the Safety, Tolerability and Pharmacokinetics of Increasing Oral Doses of TMC435350 After Single and Repeated Dosing

Hepatitis C
Tibotec Pharmaceuticals, Ireland

Completed

TMC114-C201: A Study to Determine the Antiviral Activity of TMC114 in Patients With Multiple Protease Inhibitor (PI) Resistant Human Immunodeficiency Virus (HIV) Strains

HIV Infections
Tibotec Pharmaceuticals, Ireland

Terminated

TMC278-TiDP15-C150: Trial to Examine Safety, Tolerability and Plasma Pharmacokinetics of Multiple Doses of TMC278LA.

HIV-1
Tibotec Pharmaceuticals, Ireland

Completed

TMC435-TiDP16-C121: A Study Comparing 2 Tablet Formulations of TMC435 to an Established Capsule Formulation and Evaluating the Effect of Food on Blood Levels of TMC435

Hepatitis C Virus
Tibotec Pharmaceuticals, Ireland

Completed

PEPI-TiDP23-C103: First-in-Human Study to Examine the Safety, Tolerability, and Plasma Pharmacokinetics of Increasing Single and Repeated Oral Doses of TMC558445 and of a Combined Single Day Dosing of Oral TMC558445 and Oral TMC310911 and Also Oral Darunavir

HIV-1
Tibotec Pharmaceuticals, Ireland

Completed

TMC125-C203: Phase II Randomized (Patients Are Assigned Different Treatments Based on Chance), Placebo Controlled Dose Escalating Trial of TMC125 in HIV-1 Infected Patients

HIV-1 | Anti-Retroviral Agents
Tibotec Pharmaceuticals, Ireland

Completed

TMC278-TiDP6-C130: Pharmacokinetics, Safety and Tolerability of TMC278 in Subjects With Mildly or Moderately Impaired Hepatic Function.

HIV | Hepatic Impairment | AIDS

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