Clinical Trials Sponsored by Tibotec Pharmaceuticals, Ireland

Total 118 results

Tibotec Pharmaceuticals, Ireland
Tibotec Pharmaceutical Limited

Completed

A Study to Evaluate Antiviral Activity of Darunavir + Ritonavir in HIV-1 Infected Adolescents (DIONE)

HIV-1 Infection

France, United States, Spain, Ukraine, United Kingdom, Ireland
Tibotec Pharmaceuticals, Ireland
Tibotec Pharmaceutical Limited

Completed

A Safety Study to Evaluate the Antiviral Activity of Darunavir in Combination With Ritonavir in HIV 1 Infected Children

Human Immunodeficiency Virus 1

South Africa, Argentina, Brazil, India, Kenya
Tibotec Pharmaceuticals, Ireland

Completed

TMC278-TiDP6-C209: A Clinical Trial in Treatment Naive HIV-1 Patients Comparing TMC278 to Efavirenz in Combination With Tenofovir + Emtricitabine.

HIV Infections | HIV-1 | Human Immunodeficiency Virus Type 1

United States, Australia, France, United Kingdom, Taiwan, Spain, Argentina, Portugal, Romania, South Africa, Canada, Denmark, Sweden, Netherlands, Brazil, Puerto Rico, Austria, Russian Federation, Thailand, Mexico
Tibotec Pharmaceuticals, Ireland

Completed

TMC435 HPC1004 - Phase I Study Investigating the Pharmacokinetics of TMC435 in Healthy Chinese Volunteers

Hepatitis C

Hong Kong
Tibotec Pharmaceuticals, Ireland

Approved for marketing

TMC114-C226: An Early Access Program to Evaluate the Long-term Safety and Tolerability of TMC114 Combined With a Low Dose of Ritonavir (TMC114/r) With Other Antiretrovirals, for HIV-1 Infected Patients Who Have Failed Multiple Antiretroviral Regimens.

HIV Infections

United States, Belgium, Germany, Taiwan, Spain, Switzerland, Mexico, Slovenia, Malaysia, Turkey, Canada, Netherlands, Denmark, Greece, Sweden, Russian Federation, Czech Republic, Puerto Rico, Thailand, Hungary, Luxembourg, Venezuela
Tibotec Pharmaceuticals, Ireland

Completed

TMC114-TiDP3-C176 - A Study in Healthy Volunteers Investigating the Bioequivalence Between Two Commercially Available 400-mg Tablets to One New 800-mg Tablet of Darunavir (DRV) in the Presence of Low-dose Ritonavir Under Fed and Fasted Conditions

Healthy

Germany
Tibotec Pharmaceuticals, Ireland

Completed

A Study to Investigate the Potential Pharmacokinetic Interaction Between TMC435 and Methadone

Hepatitis C

Canada
Tibotec Pharmaceuticals, Ireland

Completed

TMC435-TiDP16-C113: A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of TMC435

Hepatitis C Virus

United States
Tibotec Pharmaceuticals, Ireland

Completed

A Phase 2 Study to Evaluate Pharmacokinetics, Safety and Efficacy of TMC114/Ritonavir (Rtv) in Human Immunodeficiency Virus (HIV)-1 Infected Children and Adolescents

HIV Infections | HIV-1

United States, France, Spain, Canada, South Africa, Argentina, Brazil, Romania
Tibotec Pharmaceuticals, Ireland

Completed

TMC114-C211: Trial of an Investigational Protease Inhibitor TMC114 With Ritonavir ("TMC114/r") in HIV-1 Infected Patients Who Have Never Been Treated With Antiretroviral Medications.

HIV

United States, France, United Kingdom, Germany, Taiwan, Spain, Belgium, Chile, Costa Rica, Panama, South Africa, Canada, Greece, Singapore, Argentina, Mexico, Puerto Rico, Austria, Russian Federation, Thailand, Australia, Denmark, S... and more
Tibotec Pharmaceuticals, Ireland

Completed

A Study With TMC125 in Human Immunodeficiency Virus (HIV) Type 1 Infected Patients, Who Were Treated With TMC125 Arm in a Sponsor-Selected TMC125 Study

Human Immunodeficiency Virus Type 1
Tibotec Pharmaceuticals, Ireland

Completed

TMC435-TiDP16-C125 - Study in Healthy Volunteers to Evaluate the Potential of TMC435 to Increase the Sensitivity of the Skin Towards Exposure to Sun Light

Hepatitis C Virus
Tibotec Pharmaceuticals, Ireland

Completed

TMC435350-TiDP16-C105: Phase I, 3-way Crossover, Drug-drug Interaction Between TMC435350 and Rifampin After Multiple Dosing.

Hepatitis C | Tuberculosis | Pharmacokinetics | HCV | Rifampin
Tibotec Pharmaceuticals, Ireland

Completed

TMC435-TiDP16-C112 - Interaction Trial With Antidepressants

Hepatitis C Virus
Tibotec Pharmaceuticals, Ireland

Completed

TMC649128HPC1001 - First In-human Trial to Examine Safety, Tolerability, and Pharmacokinetics (How the Drug is Absorbed Into the Bloodstream) of Increasing Single Oral Doses of TMC649128 in Healthy Volunteers

Healthy Volunteer
Tibotec Pharmaceuticals, Ireland

Completed

TMC278-TiDP15-C158 - A Study to Examine the Safety, Tolerability and Pharmacokinetics of a Single Dose or Three Successive Doses of Intramuscularly (IM) Injected Long Acting Formulation of TMC278

HIV Infections
Tibotec Pharmaceuticals, Ireland

Completed

TMC435-TiDP16-C115 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and Erythromycin and Between TMC435 and Darunavir/Ritonavir (DRV/r)

Hepatitis C Virus

Belgium
Tibotec Pharmaceuticals, Ireland

Completed

TMC114-C213: A Phase II Randomized, Controlled, Partially Blinded Trial to Investigate Dose-response of TMC114/RTV in 3-class-experienced HIV-1 Infected Patients, Followed by an Open-label Period on the Recommended Dose of TMC114/RTV.

HIV
Tibotec Pharmaceuticals, Ireland

Completed

TMC125-TiDP2-C187: A Phase I, Open-label Trial to Investigate the Pharmacokinetic Interaction Between TMC125 and Two Antifungal Agents (Fluconazole and Voriconazole), All at Steady-state in Healthy Subjects.

Fungal Infection | HIV | AIDS
Tibotec Pharmaceuticals, Ireland

Completed

TMC125-C211: Trial of TMC125 in HIV-1 Infected Subjects Who Were in a Sponsor Selected TMC125 Trial

HIV Infection
Tibotec Pharmaceuticals, Ireland

Completed

TMC278-TiDP6-C154: Evaluation of the Possible Influence of Omeprazole Intake - and the pH Increase in the Stomach Triggered by Omeprazole Intake - on the Blood Levels of TMC278 in Healthy Volunteers

HIV Infections
Tibotec Pharmaceuticals, Ireland

Completed

TMC278-TiDP6-C136: Effect of TMC278 on Ethinylestradiol and Norethindrone in Healthy Women.

HIV | Oral Contraceptive | AIDS
Tibotec Pharmaceuticals, Ireland

Completed

TMC435350-TiDP16-C106: A Phase I Trial to Compare the Bioavailability and Plasma Pharmacokinetics After a Single Oral Dose of TMC435350 of 2 Different Solid Formulations Relative to a Powder Blend Capsule

Hepatitis C | HCV
Tibotec Pharmaceuticals, Ireland

Completed

TMC278-TiDP6-C121: Drug-drug Interaction Trial to Investigate the Potential Interaction Between TMC278 25 mg Daily and Methadone, at Steady State.

HIV
Tibotec Pharmaceuticals, Ireland

Completed

TMC278-TiDP6-C215: A Clinical Trial in Treatment Naive HIV-subjects Patients Comparing TMC278 to Efavirenz in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors

HIV Infections | HIV-1

United States, France, United Kingdom, China, Belgium, Germany, Spain, Chile, Mexico, Portugal, Costa Rica, Panama, South Africa, Canada, Brazil, Puerto Rico, Russian Federation, Thailand, Australia, India
Tibotec Pharmaceuticals, Ireland

Completed

TMC114-C214: Trial of TMC114 Administered With Low Dose Ritonavir (RTV) in HIV-1 Infected Treatment Experienced Patients

HIV Infection

United States, Australia, France, United Kingdom, Belgium, Germany, Spain, Argentina, Chile, Mexico, Portugal, Malaysia, Panama, South Africa, Canada, Netherlands, Brazil, Puerto Rico, Austria, Russian Federation, Thailand, Hungary, Denmar... and more
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
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

3

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