Search clinical trials for: TMC114-C176

Total 44 results

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
Janssen Sciences Ireland UC

Completed

TMC114-TiDP29-C232 - Study Providing Continued Access to Treatment With Darunavir (DRV)/Ritonavir (Rtv) for Children Coming From Any of the Three Ongoing Tibotec Sponsored Pediatric Studies With DRV

HIV-1 Infections

France, Ukraine, South Africa, United Kingdom, Argentina, Brazil, India, Spain
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

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

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

Completed

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

Pharmacokinetics
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
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

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
Janssen Sciences Ireland UC

Completed

TMC114IFD3001 - Study Providing Continued Access to Treatment With Darunavir (DRV)/Ritonavir(Rtv) in HIV1 Infected Adults, Adolescents and Children Aged 3 Years or Above and Coming From Previous Company Sponsored Studies With DRV

HIV-1 Infections

Costa Rica, Panama, South Africa, Ukraine, Malaysia, Brazil, Thailand, Guatemala
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 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
Janssen Pharmaceutica

Withdrawn

A Study to Assess the Safety and Effectiveness of Darunavir for Treating Human Immunodeficiency Virus-Type I (HIV-1) Infection in Filipino Patients

Human Immunodeficiency Virus-Type 1
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

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
Janssen Research & Development, LLC

Completed

A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Compared to the Co-administration of the Separate Available Formulations of Darunavir and Cobicistat Under Fed Conditions in Healthy Participants

Healthy

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

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
Janssen Korea, Ltd., Korea

Completed

A Post Marketing Survey Study to Evaluate the Safety and Effectiveness of Prezista

Acquired Immune Deficiency Syndrome

Korea, Republic of
Janssen-Cilag International NV

Completed

A Clinical Trial Comparing the Efficacy of Darunavir/Ritonavir Monotherapy Versus a Triple Combination Therapy Containing Darunavir/Ritonavir and 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Patients With Undetectable Plasma HIV-1 RNA on Current Treatment (PROTEA)

Human Immunodeficiency Virus (HIV) Infections | Acquired Immunodeficiency Syndrome (AIDS) Virus

France, United Kingdom, Belgium, Germany, Spain, Switzerland, Denmark, Israel, Austria, Poland, Hungary, Sweden, Ireland
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 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
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

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
Janssen-Cilag Ltd.

Completed

Early Access to Low-dose Ritonavir (TMC114/r) and Other Antiretrovirals (ARVs) for Treatment-naive or Early Treatment Experienced in HIV-1 Patients

HIV-1

Taiwan
Janssen-Cilag International NV

Completed

Treatment Simplification by Darunavir/Ritonavir 800/100 mg Once a Day Versus a Triple Combination Therapy With Darunavir/Ritonavir (MONET)

HIV Infections | Human Immunodeficiency Virus | Acquired Immunodeficiency Syndrome Virus | AIDS Virus

United Kingdom, Belgium, Germany, Spain, Portugal, Israel, Denmark, Russian Federation, Austria, Hungary, Switzerland
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
Janssen Research & Development, LLC

Completed

A Study to Assess the Acceptability of the Darunavir/Cobicistat (DRV/COBI) Fixed-dose Combination (FDC) Tablet in Human Immunodeficiency Virus (HIV)-1 Infected Children

Human Immunodeficiency Virus (HIV)

United States, Spain, South Africa
Janssen Scientific Affairs, LLC

Completed

A Single-arm, Open-label, Study to Assess the Pharmacokinetics of Darunavir and Ritonavir, Darunavir and Cobicistat, Etravirine, and Rilpivirine in HIV-1 Infected Pregnant Women

HIV Infections | Pregnancy | HIV

United States, Puerto Rico
St Stephens Aids Trust

Terminated

NNRTI/PI Toxicity Switch to Darunavir Study

HIV

United Kingdom
Hospital Central Sur de Pemex

Terminated

Safety Study of Renal Function in Patients With Chronic Kidney Failure Taking Lumiracoxib or Diclofenac for Arthralgia

Arthralgia | Kidney Failure, Chronic

Mexico
Gilead Sciences
Janssen Research & Development, LLC

Completed

Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults

HIV Infections | Acquired Immunodeficiency Syndrome

United States, Puerto Rico
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
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 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
Janssen Research & Development, LLC

Completed

A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Under Fed Conditions

Healthy

Belgium
Janssen Pharmaceutical K.K.

Completed

A Study to Evaluate the Pharmacokinetics (PK) of Darunavir (DRV) and Cobicistat (COBI) After a Single Oral Administration of Darunavir/Cobicistat Fixed-Dose Combination in Healthy Japanese Adult Participants

Healthy

Japan
St Stephens Aids Trust

Completed

Atazanavir/Ritonavir and Darunavir/Ritonavir PK Tail Study

HIV Infections | HIV

United Kingdom
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

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
St Stephens Aids Trust

Completed

Pharmacokinetics (PK) Study of Once Daily Darunavir/Ritonavir and Twice and Once Daily Raltegravir in HIV-infected Subjects

HIV Infections

United Kingdom
Janssen Pharmaceutica N.V., Belgium

Terminated

A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat When Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Co-administration of the Separate Agents

Healthy

Netherlands
Janssen Research & Development, LLC

Completed

A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat as Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared With Co-administration of the Separate Agents

Healthy

Netherlands

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