Clinical trials: Rilpivirine
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
Healthy
A Study to Evaluate the Pharmacokinetics of Rilpivirine/Tenofovir/Emtricitabine After a Single-Oral Administration in Healthy Japanese Adult Male Participants
The purpose of this study is to evaluate the pharmacokinetics (PK) of rilpivirine/Tenofovir/Emtricitabine (RPV/TFV/FTC) after a single-oral administration of Complera (the fixed-dose combination of RPV, FTC, Tenefovir disoproxil…
- Trial name
- NCT02530060
- Testing
- Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine FDC
- Where
- Japan
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Janssen Pharmaceutical K.K.
HIV Infections
A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants
This is an open-label, dose-escalation study to investigate the safety, tolerability and pharmacokinetics (PK) of single subcutaneous (SC) administration of long acting (LA) Cabotegravir (CAB) 200 milligrams per milliliter…
- Trial name
- NCT05418868
- Testing
- Cabotegravir 200 mg/mL, CAB >=400 mg/mL, CAB Formulation I
- Where
- 3 sites in United States
- Volunteers
- 214 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Infection, Human Immunodeficiency Virus
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Repeat Dose Administration of Long-Acting GSK1265744 and Long-Acting TMC278 Intramuscular and Subcutaneous Injections in Healthy Adult Subjects
LAI115428 is a Phase I, randomized, repeat dose escalation study to determine the safety, tolerability, and PK profile of intramuscular and subcutaneous injections of GSK1265744 in a long acting parenteral (LAP) formulation in…
- Trial name
- NCT01593046
- Testing
- GSK1265744 Oral, GSK1265744 LAP 800mg intramuscular injection, GSK1265744 LAP 200mg subcutaneous injection
- Where
- 2 sites in United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
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
Healthy
A Clinical Study of the Interactions Between Azvudine Tablets (FNC) and Rilpivirine Tablets (RPV)
Azvudine(FNC)，a nucleoside reverse transcriptase inhibitor, make itself a better candidate to be co-formulated in other anti-HIV therapies, thus to improve patient's compliance.
- Trial name
- NCT07001488
- Testing
- Azvudine tablets(FNC) and Rilpivirine Tablets (RPV), Azvudine tablets (FNC) and Rilpivirine Tablets (RPV)
- Where
- China
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Henan Genuine Biotech Co., Ltd.
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
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
The purpose of this study is to investigate the extent by which intake of 20 mg once daily (q.d.) omeprazole influences the levels of TMC278 in the blood after intake of 25 mg q.d..
- Trial name
- NCT01001247
- Testing
- TMC278; Omeprazole
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Healthy
A Study to Investigate the Effect of Different Particle Sizes on the Single-dose Pharmacokinetics of Rilpivirine After Intramuscular Injection of a Long-acting Nanosuspension in Healthy Participants
The main purpose of this study is to characterize the single-dose pharmacokinetics (PK) of rilpivirine (RPV) after intramuscular (IM) injection of rilpivirine long-acting parenteral formulation (RPV LA) nanosuspensions with…
- Trial name
- NCT03127189
- Testing
- Rilpivirine, Rilpivirine Long-acting Parenteral Formulation
- Where
- 2 sites in United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
HIV, AIDS
TMC278-TiDP6-C130: Pharmacokinetics, Safety and Tolerability of TMC278 in Subjects With Mildly or Moderately Impaired Hepatic Function.
The purpose of this study is to investigate the pharmacokinetics (how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body) after a single dose and after repeated administration of…
- Conditions
- HIV, AIDS, Hepatic Impairment
- Trial name
- NCT00736905
- Testing
- TMC278
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
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
Cardiovascular Disease
Efavirenz Versus Rilpivirine on Vascular Function, Inflammation, and Oxidative Stress
The purpose of this study is to compare the cardiovascular profiles of efavirenz and rilpivirine, which are two drugs used to treat HIV infection.
- Trial name
- NCT01585038
- Testing
- Efavirenz, Rilpivirine
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Indiana University
Healthy Participants
A Study to Explore Pharmacokinetic Interaction Between Rilpivirine and Metformin in Healthy Participants
The purpose of the study is to evaluate the effect of steady-state (constant concentration of medication in the blood) rilpivirine on pharmacokinetics (how a single dose of metformin is absorbed in the body, distributed within…
- Trial name
- NCT01719614
- Testing
- Metformin, Rilpivirine
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Janssen R&D Ireland
Healthy
A Study of a Rilpivirine Extended-Release Suspension in Healthy Participants
The purpose of this study is to characterize the single dose pharmacokinetics (PK) and evaluate the safety and tolerability of subcutaneous administration of rilpivirine (RPV) long-acting (LA) or RPV LA in combination with…
- Trial name
- NCT05112939
- Testing
- RPV LA, CAB LA
- Where
- 3 sites in United States, Netherlands
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
HIV
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
The purpose of this study is to investigate the pharmacokinetics of TMC278 (rilpivirine) 25 mg once daily following a preceding 2-week treatment period with efavirenz 600 mg once daily in healthy volunteers
- Trial name
- NCT01268839
- Testing
- TMC278, Efavirenz
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Tibotec, Inc
Human Immunodeficiency Virus Type 1
A Study to Evaluate the Pharmacokinetic Effects of Different Storage Conditions for a Long-Acting Nanosuspension of Rilpivirine on Pharmacokinetics
The purpose of this study is to compare the single-dose pharmacokinetics of rilpivirine (RPV) after intramuscular (IM) injection of rilpivirine long-acting parenteral formulation (RPV-LA) and 'aged' RPV-LA, in healthy adult…
- Trial name
- NCT02547870
- Testing
- Rilpivirine (RPV), Rilpivirine Long-Acting Parenteral Formulation (RPV-LA), Aged RPV-LA
- Where
- Belgium
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Janssen Infectious Diseases BVBA
HIV, Antiviral Agents
Antiviral Long Acting Drugs Landing in People Living With HIV
This is a monocentric, prospective, double-arm, randomized, open-label, implementation-effectiveness hybrid type III study aimed at comparing hospital-based and home-based administration of CAB LA + RPV LA treatment for…
- Trial name
- ALADDIN (NCT06468995)
- Testing
- Surveys completion, Home administration of CAB+RPV, Hospital administration of CAB+RPV
- Where
- Italy
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- IRCCS San Raffaele
Infection, Human Immunodeficiency Virus, HIV Infections
Bioequivalence Study of a Fixed-dose Combination (FDC) of Dolutegravir (DTG) and Rilpivirine (RPV)
The purpose of the study is to evaluate the bioequivalence between Fixed-dose Combination (FDC) tablet formulation of Dolutegravir (DTG) 50 milligrams (mg) and Rilpivirine (RPV) 25 mg versus co-administration of the separate…
- Trial name
- NCT02741557
- Testing
- DTG, RPV, DTG/RPV FDC
- Where
- United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV Infections, Contraception
Kuwa Free! - Live Free!
The study investigators are conducting foundational pharmacokinetic (PK) and qualitative studies, among 15-24 years old (inclusive) adolescent girls and young women living with HIV (AGYWLHIV) already on oral antiretroviral…
- Conditions
- HIV Infections, Contraception, Drug-drug Interaction
- Trial name
- NCT05044962
- Testing
- Cabotegravir/ Rilpivirine, Etonogestrel (ETG) implant, Intramuscular depo-medroxyprogesterone acetate (IM DMPA)
- Where
- Kenya
- Volunteers
- 700 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Healthy
Relative Bioavailability of Three Oral Formulations Candidates of Rilpivirine for Potential Pediatric Use Compared to Oral Tablet
The purpose of this study is to compare the rate and extent of absorption of rilpivirine in healthy adult participants following: 1) administration of a single dose of two different oral dispersible tablet formulation candidates…
- Trial name
- NCT02561936
- Testing
- Rilpivirine Oral Tablet, Rilpivirine formulation G007, Rilpivirine formulation G009-01
- Where
- Belgium
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Janssen Sciences Ireland UC