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TMC278

DRUG11 trials

Sponsors

Tibotec Pharmaceuticals, Ireland, Tibotec, Inc, Janssen Pharmaceutical K.K.

Conditions

AIDSBioavailabilityHIVHIV InfectionsHIV-1HealthyHepatic ImpairmentHepatitis C Virus

Phase 1

TMC278-TiDP6-C130: Pharmacokinetics, Safety and Tolerability of TMC278 in Subjects With Mildly or Moderately Impaired Hepatic Function.
CompletedNCT00736905
Tibotec Pharmaceuticals, IrelandAIDS, Hepatic Impairment, HIV
Start: 2008-06-30End: 2009-11-30Updated: 2010-04-28
TMC278-TiDP6-C136: Effect of TMC278 on Ethinylestradiol and Norethindrone in Healthy Women.
CompletedNCT00739622
Tibotec Pharmaceuticals, IrelandAIDS, HIV, Oral Contraceptive
Start: 2008-07-31End: 2008-12-31Updated: 2010-04-28
TMC278-TiDP15-C150: Trial to Examine Safety, Tolerability and Plasma Pharmacokinetics of Multiple Doses of TMC278LA.
TerminatedNCT00741741
Tibotec Pharmaceuticals, IrelandHIV-1
Start: 2008-07-31End: 2009-11-30Updated: 2010-10-26
TMC278-TiDP6-C121: Drug-drug Interaction Trial to Investigate the Potential Interaction Between TMC278 25 mg Daily and Methadone, at Steady State.
CompletedNCT00744770
Tibotec Pharmaceuticals, IrelandHIV
Start: 2008-10-31End: 2009-06-30Updated: 2010-04-28
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
CompletedNCT00812292
Tibotec Pharmaceuticals, IrelandBioavailability, HIV-1, Pharmacokinetics
Start: 2009-01-31End: 2009-04-30Updated: 2011-06-09
TMC435-TiDP16-C114 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and the Antiretroviral Agents TMC278 and Tenofovir
CompletedNCT01205139
Tibotec Pharmaceuticals, IrelandHepatitis C Virus
Start: 2010-11-30End: 2011-03-31Updated: 2012-11-27
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
CompletedNCT01268839
Tibotec, IncHIV
Start: 2010-01-31End: 2010-05-31Updated: 2013-09-04
TMC278-TiDP6-C153 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC278 and Raltegravir
CompletedNCT01288755
Tibotec Pharmaceuticals, IrelandHIV Infections
Start: 2011-02-28End: 2011-05-31Updated: 2011-06-27

Phase 3

TMC278-TiDP6-C209: A Clinical Trial in Treatment Naive HIV-1 Patients Comparing TMC278 to Efavirenz in Combination With Tenofovir + Emtricitabine.
CompletedNCT00540449
Tibotec Pharmaceuticals, IrelandHIV-1, HIV Infections, Human Immunodeficiency Virus Type 1
Start: 2008-05-31End: 2011-12-31Updated: 2016-03-29
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
CompletedNCT00543725
Tibotec Pharmaceuticals, IrelandHIV-1, HIV Infections
Start: 2008-06-30End: 2012-02-29Updated: 2016-04-01

Phase 4

A Single-Dose Pharmacokinetics and Safety Study of TMC278 in Healthy Adult Japanese Participants
CompletedNCT01804244
Janssen Pharmaceutical K.K.Healthy
Start: 2013-03-31End: 2013-03-31Updated: 2014-03-19

Related Papers

Pharmacokinetics, Safety and Antiviral Activity of Rilpivirine in Antiretroviral-naïve Children With HIV ≥6 to <12 Years Old: Week 48 and Final Analysis of Cohort 2 From the Open-label, Phase 2 PAINT Study
The Pediatric Infectious Disease Journal2025-04-181 citations
Effect of Efavirenz on the Pharmacokinetics of SHR6390 in Healthy Volunteers
Drug Design Development and Therapy2024-07-013 citations
Lack of an effect of rilpivirine on the pharmacokinetics of ethinylestradiol and norethindrone in healthy volunteers.
2014-02-0114 citations
The effect of rilpivirine on the pharmacokinetics of methadone in HIV-negative volunteers
The Journal of Clinical Pharmacology2013-11-0710 citations
Efficacy and safety of rilpivirine in treatment-naive, HIV-1-infected patients with hepatitis B virus/hepatitis C virus coinfection enrolled in the Phase III randomized, double-blind ECHO and THRIVE trials.
2012-04-2428 citations
Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial.
2011-07-01299 citations
Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naive adults infected with HIV-1 (THRIVE): a phase 3, randomised, non-inferiority trial.
2011-07-01273 citations