Clinical trials: Rilpivirine
Human Immunodeficiency Virus Infections
A Study to Determine the Safety and Efficacy of Rilpivirine in Treatment-naive Indian Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection
The primary purpose of the study is to evaluate the efficacy of rilpivirine (RPV)-based regimen in human immunodeficiency virus type 1 (HIV-1) infected, antiretroviral (ARV) treatment-naive participants, as determined by the…
- Trial name
- RISE (NCT03563742)
- Testing
- Rilpivirine 25 mg, Tenofovir Disoproxil Fumarate (TDF)/Lamivudine (3TC)
- Where
- 5 sites in India
- Volunteers
- 58 people
- Sponsor
- Janssen Research & Development, LLC
HIV-1 Infection
Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI) and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to a Fixed-dose Tablet Containing Emtricitabine/Rilpivirine/Tenofovir DF
The purpose of this randomized, open-label, multicenter, active-controlled Phase 3b study is to evaluate the noninferiority of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) single-tablet regimen (STR…
- Trial name
- NCT01252940
- Testing
- FTC/RPV/TDF, PI, RTV
- Where
- 111 sites in United States, Austria and 8 more
- Volunteers
- 482 people
- Sponsor
- Gilead Sciences
Human Volunteers
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.
This is a study to evaluate the effect of TMC278 25 mg daily on the QT/QTc interval (heart conduction and heart rhythm) in healthy volunteers.
- Trial name
- NCT00744809
- Testing
- TMC278; Moxifloxacin; Efavirenz
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
HIV-1 Infection
Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Adults
The primary objective of this study is to evaluate the non-inferiority of switching to emtricitabine/rilpivirine/tenofovir alafenamide (FTC/RPV/TAF) fixed dose combination (FDC) as compared to continuing the non-nucleoside…
- Trial name
- NCT02345226
- Testing
- FTC/RPV/TAF, EFV/FTC/TDF
- Where
- 117 sites in United States, Belgium and 7 more
- Volunteers
- 881 people
- Sponsor
- Gilead Sciences
HIV Infections
Phase 2b, Open-label, Multicenter, Rollover Study to Assess Antiviral Activity and Safety of Long-acting (LA) Cabotegravir (CAB) Plus LA Rilpivirine (RPV), Administered Every 2 Months (Q2M), in Human Immunodeficiency Virus (HIV)-Positive Participants From the LATTE Study
This study (POLAR), is designed to assess the antiviral activity and safety of CAB LA plus RPV LA, administered Q2M, in approximately 100 adult HIV-1 infected, antiretroviral therapy (ART) experienced participants.
- Trial name
- NCT03639311
- Testing
- CAB LA, RPV LA, RPV
- Where
- 30 sites in United States, Canada
- Volunteers
- 97 people
- Sponsor
- ViiV Healthcare
Healthy
A Study to Explore the Pharmacokinetics of Rilpivirine With Rifabutin in Healthy Participants
The purpose of this study is to explore the pharmacokinetics of different dosing regimens of rilpivirine in combination with rifabutin in healthy participants.
- Trial name
- NCT01615614
- Testing
- Rilpivirine, Rifabutin
- Where
- Belgium
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Janssen R&D Ireland
Healthy Subject
A Study of Bioavailability and Food Effect of SACT-1 and Edurant® Tablets in Healthy Adult Volunteers
This was a Phase 1, open-label, randomized, single center, 3-period, 3-sequence, single-dose crossover bioavailability and food effect study between SACT-1 and Edurant® tablet.
- Trial name
- NCT05358756
- Testing
- SACT-1, EDURANT 25Mg Tablet
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Aptorum International Limited
HIV Infections
Study to Evaluate Pharmacokinetics, Safety and Tolerability of Dolutegravir and Rilpivirine (JULUCA™) 50 Milligram (mg)/25 mg Tablets in Healthy Subjects of Japanese Descent
Dolutegravir (DTG), a human immunodeficiency virus (HIV)-1 integrase inhibitor (INI), and Rilpivirine (RPV), a non-nucleoside HIV-1 reverse transcriptase inhibitor (NNRTI), are each approved in the United States (US), European…
- Trial name
- NCT03984838
- Testing
- JULUCA (Dolutegravir and Rilpivirine) 50mg/25mg FDC tablet
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections
A Study Evaluating Implementation Strategies for Cabotegravir (CAB)+ Rilpivirine (RPV) Long-acting (LA) Injectables for Human Immunodeficiency Virus (HIV)-1 Treatment in European Countries
The overall objective of the CAB LA + RPV LA clinical development program is to develop a highly effective, well-tolerated, two-drug, LA injectable regimen which has the potential to offer improved treatment convenience…
- Trial name
- NCT04399551
- Testing
- CAB OLI, CAB LA, RPV OLI
- Where
- 18 sites in Belgium, France and 3 more
- Volunteers
- 437 people
- Sponsor
- ViiV Healthcare
HIV Infections
Study to Identify and Determine Best Implementation Practices for Injectable Cabotegravir+Rilpivirine in the United States (US)
Chronic human immunodeficiency virus (HIV) infection in adults continues to be characterized by increased development of resistant virus, increased transmission of resistant virus and issues associated with the long-term toxicity…
- Trial name
- NCT04001803
- Testing
- CAB LA+RPV LA
- Where
- 9 sites in United States
- Volunteers
- 115 people
- Sponsor
- ViiV Healthcare
HIV
TMC278-TiDP6-C121: Drug-drug Interaction Trial to Investigate the Potential Interaction Between TMC278 25 mg Daily and Methadone, at Steady State.
The purpose of this Phase I, open-label, single-sequence drug-drug interaction trial in patients on stable methadone maintenance therapy is to investigate the potential interaction between TMC278 25 mg daily and methadone, at…
- Trial name
- NCT00744770
- Testing
- TMC278
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
HIV Infections
Study of Lenacapavir, Teropavimab, and Zinlirvimab Versus Cabotegravir and Rilpivirine in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy
The goal of this clinical study is to compare how effective a long-acting injectable treatment of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) versus (CAB) and rilpivirine (RPV) injections given every 8 weeks in…
- Trial name
- NCT07682961
- Testing
- Lenacapavir, Lenacapavir Tablet, Teropavimab
- Where
- 19 sites in United States, Australia and 1 more
- Volunteers
- 590 people
- Sponsor
- Gilead Sciences
HIV Infections
Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics
The purpose of this study is to provide data on the pharmacokinetic (PK), safety, tolerability, efficacy and acceptability of this fixed dose combination (FDC) single tablet 2-drug regimen for virologically suppressed (HIV-1 RNA…
- Trial name
- NCT05674656
- Testing
- Dolutegravir/Rilpivirine FDC
- Where
- 8 sites in United States
- Volunteers
- 20 people
- Sponsor
- ViiV Healthcare
Healthy
A Study to Investigate the Effect of Steady-State TMC278 on the Pharmacokinetics of a Single Dose of Digoxin
The purpose of this study is to investigate the effect of steady-state (constant concentration of medication in the blood) TMC278 on the single dose pharmacokinetics (what the body does to the medication) of digoxin.
- Trial name
- NCT01519128
- Testing
- Treatment A: Digoxin, Treatment B: TMC278
- Where
- Belgium
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Janssen R&D Ireland
HIV Infections
Study Using CABENUVA™ for the Treatment of Human Immunodeficiency Virus (HIV)-1, Administered in Infusion Centers (IC) or Alternate Sites of Administration (ASA) in the United States (U.S.)
GLACIER (Giving Long Acting CABENUVA in an Infusion center/ASA) is an interventional study examining the administration of CABENUVA (Cabotegravir long acting [LA] plus Rilpivirine LA) intramuscular (IM) in infusion centers/ASAs…
- Trial name
- GLACIER (NCT04982445)
- Testing
- CABENUVA
- Where
- 15 sites in United States
- Volunteers
- 44 people
- Sponsor
- ViiV Healthcare
Pharmacokinetics, Bioavailability
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
The purpose of this study is to evaluate how much and how fast a single, oral, daily 25 mg dose of TMC278 is absorbed into the body when administered as a solution, suspension, granules, or a tablet.
- Conditions
- Pharmacokinetics, Bioavailability, HIV-1
- Trial name
- NCT00812292
- Testing
- TMC278
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
HIV-1
A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children Aged Greater Than or Equal to 6 Years
The purpose of this study is to evaluate the pharmacokinetics, safety and antiviral activity of rilpivirine (TMC278) 25 milligram (mg) or adjusted dose once daily in combination with an investigator-selected background regimen…
- Trial name
- NCT00799864
- Testing
- Rilpivirine, Zidovudine, Abacavir
- Where
- 17 sites in United States, India and 6 more
- Volunteers
- 54 people
- Sponsor
- Janssen Sciences Ireland UC
Hepatitis C, HIV
TMC125IFD1001 - Drug-Drug Interaction of Etravirine With Telaprevir and TMC278 With Telaprevir.
The purpose of this study is to see the effect of etravirine or TMC278 on how telaprevir is absorbed into the body and the effect of telaprevir on how etravirine or TMC278 are absorbed into the body when administered together.
- Trial name
- NCT01336829
- Testing
- ETR/telaprevir, TMC278/telaprevir, telaprevir/ETR
- Where
- Belgium
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
HIV Infections
TMC278-TiDP6-C153 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC278 and Raltegravir
The purpose of this study is to investigate the effect of steady-state concentrations of raltegravir (administered as 400 mg, twice daily) on the steady-state pharmacokinetics of TMC278 (25 mg, once daily), and vice versa.
- Trial name
- NCT01288755
- Testing
- TMC278, Raltegravir
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
HIV Infections
Regimen Switch to Dolutegravir + Rilpivirine From Current Antiretroviral Regimen in Human Immunodeficiency Virus Type 1 Infected and Virologically Suppressed Adults (SWORD-2)
The aim of this study was to determine if virologically suppressed, human immunodeficiency virus type 1 (HIV-1) infected adults on an antiretroviral regimen (including 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus a…
- Trial name
- NCT02422797
- Testing
- DTG 50 mg, RPV 25 mg, CAR
- Where
- 61 sites in United States, Argentina and 9 more
- Volunteers
- 518 people
- Sponsor
- ViiV Healthcare