Clinical trials: Rilpivirine
Human Immunodeficiency Virus Type 1 (HIV-1)
Study to Assess the Effects of Cabotegravir (CAB) and Rilpivirine (RPV) Long-Acting (LA) Injections Following Sub-cutaneous (SC) Administration Compared With Intramuscular (IM) Administration in Adult Participants Living With Human Immunodeficiency Virus (HIV-1) Infection in the FLAIR Study
This study will assess the pharmacokinetics, safety, tolerability, maintenance of virological suppression and patient reported outcomes for participants receiving CAB and RPV LA injections following SC administration in the…
- Trial name
- NCT05896748
- Testing
- Cabotegravir - Injectable Suspension (CAB LA), Rilpivirine - Injectable Suspension (RPV LA)
- Where
- 30 sites in United States, Canada and 4 more
- Volunteers
- 94 people
- Sponsor
- ViiV Healthcare
Infection, Human Immunodeficiency Virus, HIV Infections
A Phase IIb Study to Evaluate a Long-Acting Intramuscular Regimen for Maintenance of Virologic Suppression (Following Induction With an Oral Regimen of GSK1265744 and Abacavir/Lamivudine) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected, Antiretroviral Therapy-Naive Adult Subjects
This study is a Phase IIb, randomized, multicentre, parallel group, open-label, study having an overall objective to evaluate the antiviral activity, tolerability, and safety of two intramuscular (IM) dosing regimens of GSK744 LA…
- Trial name
- NCT02120352
- Testing
- CAB Oral Tablets, CAB LA, ABC/3TC Oral tablets
- Where
- 50 sites in United States, Canada and 3 more
- Volunteers
- 309 people
- Sponsor
- ViiV Healthcare
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
Human Immunodeficiency Virus Type 1 (HIV-1) Infection
A Study on the Safety and Effectiveness of Rilpivirine Hydrochloride (Edurant) Among Adult Filipino Patients With Human Immunodeficiency Virus Type-I Infection
The purpose of this study is to assess the safety and effectiveness of rilpivirine hydrochloride in combination with other anti-retroviral (ARV) medications for the treatment of ARV-naive (patients who have not been exposed to…
- Trial name
- NCT01692470
- Testing
- No intervention
- Sponsor
- Janssen Pharmaceutica
HIV Infections
A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy
This is a multicentre study carried out in participants living with human immunodeficiency virus type 1 (HIV-1) who have not previously been treated with any antiretroviral therapies.
- Trial name
- VOLITION (NCT05917509)
- Testing
- DTG/3TC, Cabotegravir (CAB) LA, Rilpivirine (RPV) LA
- Where
- 47 sites in United States, Argentina and 7 more
- Volunteers
- 171 people
- Sponsor
- ViiV Healthcare
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
HIV-1 Infection
Study to Evaluate Switching From a Regimen Consisting of the Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (STR) to the Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate STR
The purpose of this Phase 2b study was to evaluate the efficacy and safety of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) STR, after switching from the efavirenz (EFV)/FTC/TDF STR at baseline, in…
- Trial name
- NCT01286740
- Testing
- FTC/RPV/TDF
- Where
- 18 sites in United States
- Volunteers
- 50 people
- Sponsor
- Gilead Sciences
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
HIV
Pre-Approval Access to Rilpivirine Long Acting (RPV LA) Injectable Suspension for the Treatment of a Participant With Human Immunodeficiency Virus (HIV)-1 Infection
The main purpose of this pre-approval access program (PAAP) is to provide rilpivirine Long Acting (RPV LA) injectable suspension for the treatment of human immunodeficiency virus (HIV)-1 infection as single patient request to…
- Trial name
- NCT03847376
- Testing
- Rilpivirine Long Acting (RPV LA)
- Sponsor
- Janssen Sciences Ireland UC
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 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
Infection, Human Immunodeficiency Virus, HIV Infections
Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults
The Antiretroviral Therapy as Long Acting Suppression (ATLAS) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult subjects with current viral suppression on a regimen with 2…
- Trial name
- NCT02951052
- Testing
- Cabotegravir (CAB) tablet, Rilpivirine (RPV) tablet, Cabotegravir - Injectable Suspension (CAB LA)
- Where
- 113 sites in United States, Argentina and 11 more
- Volunteers
- 618 people
- Sponsor
- ViiV Healthcare
Hepatitis C Virus
TMC435-TiDP16-C114 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and the Antiretroviral Agents TMC278 and Tenofovir
The purpose of this study is to investigate the effect of steady-state concentrations of TMC435 on the steady-state pharmacokinetics of TMC278 or Tenofovir , and vice versa.
- Trial name
- NCT01205139
- Testing
- TMC435, TDF, TMC435 + TDF
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, 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 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
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
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
Human Immunodeficiency Virus Type 1
A Roll-over Study With Rilpivirine for Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Who Participated in Rilpivirine Pediatric Studies
The purpose of this study is to provide continued access to rilpivirine (RPV) for participants who were treated with RPV in a clinical development pediatric study with rilpivirine and who, at the time of roll-over, experience and…
- Trial name
- NCT02494986
- Testing
- Rilpivirine
- Where
- 8 sites in Portugal, South Africa and 3 more
- Volunteers
- 48 people
- Sponsor
- Janssen Sciences Ireland UC
HIV, AIDS
TMC278-TiDP6-C136: Effect of TMC278 on Ethinylestradiol and Norethindrone in Healthy Women.
The purpose of this study is to investigate the pharmacokinetic interaction between the combination of ethinylestradiol and norethindrone and TMC278 25 mg once daily.
- Conditions
- HIV, AIDS, Oral Contraceptive
- Trial name
- NCT00739622
- Testing
- TMC278
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
HIV Infections
Pharmacokinetic Study of Cabotegravir and Rilpivirine Long-acting Intramuscular Injections in Healthy Adult Participants
This is a phase 1, open label study in healthy participants to assess the pharmacokinetics of cabotegravir and rilpivirine in plasma following the administration of a single 600 milligram (mg) and a 900 mg intramuscular (IM)…
- Trial name
- NCT04371380
- Testing
- Cabotegravir Tablets, Rilpivirine Tablets, Cabotegravir extended release suspension for injection (long-acting)
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare