Clinical Trials Sponsored by Tibotec, Inc

Total 35595 results

Vertex Pharmaceuticals Incorporated
Tibotec, Inc

Completed

A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Did Not Respond to Therapy

Hepatitis C

United States, France, United Kingdom, Germany, Canada, Netherlands, Austria, Puerto Rico
Tibotec BVBA
Tibotec Pharmaceutical Limited

Completed

A Safety and Effectiveness Study of Telaprevir in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment

Hepatitis C, Chronic

United States, Australia, France, United Kingdom, Germany, Spain, Belgium, Israel, Canada, Brazil, Austria, Poland, Netherlands, Sweden, Switzerland, Puerto Rico
Northwestern University
Pfizer; Tibotec, Inc

Completed

Maraviroc Plus Darunavir/Ritonavir for Treatment-Naïve Patients Infected With R5-tropic HIV-1 (MIDAS)

HIV Infections | HIV-1 Infection

United States
Tibotec BVBA

Terminated

TMC649128HPC1002 - a Trial inGenotype 1 Hepatitis C Virus (HCV) - Infected Participants to Determine the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of TMC649128, Alone and Combined With Pegylated Interferon + Ribavirin

Hepatitis C Virus

Poland, Netherlands
Tibotec BVBA

Completed

VX-950-TiDP24-C133 - A Phase I Study Investigating the Interaction Between Telaprevir and Escitalopram

Hepatitis C
Tibotec BVBA

Completed

VX-950-TiDP24-C132: A Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of Telaprevir.

Kidney Diseases | Hepatitis C
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 BVBA

Completed

An Open-Label Study of Telaprevir Administered Every 12 or 8 Hours in Combination With One of Two Pegylated Interferons and Ribavirin in Treatment-Naive Genotype 1 Chronic Hepatitis C Participants

Chronic Hepatitis C

France, Spain, Belgium, Germany, Austria, Netherlands
Tibotec BVBA

Completed

An Exploratory Study of Telaprevir in Treatment-Naive Participants With Chronic Genotype 4 Hepatitis C Virus Infection

Hepatitis C
Tibotec BVBA

Completed

A Phase 2a Study to Evaluate Viral Kinetics and Safety of Telaprevir in Participants With Genotype 2 or 3 Hepatitis C Infection

Hepatitis C, Chronic

France, United Kingdom, Sweden
Tibotec BVBA

Completed

A Study to Determine the Relative Oral Bioavailability of Single Dose Administration of TMC207, Under Fed and Fasted Conditions in Healthy Participants

Healthy
Tibotec BVBA

Completed

TMC207TBC1003 - A Study in Healthy Volunteers Investigating the Effect of Single-dose TMC207 on the QT/QTc Interval Under Fed Conditions

Healthy Volunteer
Tibotec BVBA

Completed

TMC207-TiDP13-C110: Interaction Study With Lopinavir/Ritonavir in Healthy Volunteer

HIV | Tuberculosis
Tibotec BVBA

Completed

VX-950-TiDP24-C134: Drug-drug Interaction Trial Between Combination of Efavirenz and Tenofovir Disoproxil Fumarate and Different Dosages of Telaprevir on Healthy Volunteer

Hepatitis C | HIV | HCV | AIDS
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, Inc
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA

Completed

A Study to Evaluate the Pharmacokinetic Profile (How the Body Absorbs, Distributes, Metabolizes and Eliminates a Drug) of TMC125 Plus Tenofovir/Emtricitabine Once Daily With or Without Darunavir/r Once Daily in Antiretroviral (ARV) Naive HIV-1 Patients (Patients Have Never Received ARV Treatment).

HIV-1 Infection
Tibotec BVBA

Completed

TMC207-TiDP13-C117: Interaction Study in Human Immunodeficiency Virus-type 1 (HIV-1) Infected Patients With Nevirapine (NVP)

HIV Infections

South Africa
Tibotec BVBA

Completed

A Study of TMC207 in Patients With Moderately Impaired Hepatic Function

Moderate Hepatic Impairment
Tibotec BVBA

Completed

TMC207-C202: Study to Evaluate Bactericidal Activity of Multiple Oral Doses of TMC207 in Subjects With Sputum-Smear Positive Tuberculosis

Tuberculosis
Tibotec BVBA

Completed

VX-950-TiDP24-C124: A Phase I Trial to Investigate the Potential Pharmacokinetic Interactions Between Telaprevir and Darunavir/Ritonavir and Between Telaprevir and Fosamprenavir/Ritonavir at Steady-state.

Hepatitis C | HIV | Telaprevir
Tibotec, Inc
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA

Completed

Enfuvirtide/Current Protease Inhibitor Switch to PREZISTA (Darunavir)/Ritonavir + TMC125 in HIV Patients With Enfuvirtide Side Effects.

HIV

United States
Therapeutic Concepts
Abbott; Tibotec, Inc; BluKyne

Completed

A Pilot Study of Kaletra and Intelence Tablets in Naive Subjects (KALYINTE)

HIV Infections

United States
Tibotec, Inc
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA

Completed

Changes in Triglyceride and Other Lipids (Levels of Fats Found in Blood) When Taking Darunavir Compared to Atazanavir in HIV-infected Patients That Have Never Received Treatment

HIV

United States
Tibotec, Inc
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA

Completed

GRACE: A Study to Compare the Effectiveness, Safety and Tolerability of PREZISTA (Darunavir)/Ritonavir by Gender and Race When Administered With Other Antiretroviral Medications in Human Immunodeficiency Virus (HIV) Positive Women and Men.

HIV | Infectious

United States, Canada, Puerto Rico
Tibotec, Inc
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA

Completed

A Study of the Once Daily Combination of Etravirine and Darunavir/Ritonavir As Dual Therapy in Early Treatment-Experienced Patients (INROADS)

Human Immunodeficiency Virus (HIV)

United States, Puerto Rico
Tibotec, Inc
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA

Completed

A Phase I, Open-label Trial to Explore the Pharmacokinetics, Safety and Tolerability of TMC278 (Rilpivirine) 25 mg Once Daily Following a 2-week Period Receiving Efavirenz, in Healthy Male and Female Volunteers

HIV
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

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