Clinical trials: Rilpivirine
HIV-1 Infection
Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
The purpose of the study was to evaluate the safety and efficacy of the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) compared with the efavirenz (EFV)/FTC/TDF STR in HIV-1…
- Trial name
- NCT01309243
- Testing
- FTC/RPV/TDF, EFV/FTC/TDF
- Where
- 151 sites in United States, Australia and 12 more
- Volunteers
- 799 people
- Sponsor
- Gilead Sciences
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-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
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
The Rilpivirine Cerebrospinal-fluid (CSF) Study
This is a phase I pharmacokinetic study of HIV positive patients stable on antiretroviral therapy who will switch treatment when enrolled from nevirapine to rilpivirine.
- Trial name
- NCT01562886
- Testing
- Rilpivirine
- Where
- United Kingdom
- Volunteers
- 14 people
- Sponsor
- Imperial College London
HIV Infections
Improving Treatment and Retention Adherence in Nontraditional Settings
This is a hybrid implementation-effectiveness study using both qualitative and quantitative methods. The research aims to examine whether providing a new, but approved, HIV once a month injection treatment…
- Trial name
- I-TRAINS (NCT04973254)
- Testing
- CAB-RPV LA, Standard treatment within an HIV clinic
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- Boston Medical Center
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
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
HIV Infections, HIV-1
TMC278-TiDP6-C209: A Clinical Trial in Treatment Naive HIV-1 Patients Comparing TMC278 to Efavirenz in Combination With Tenofovir + Emtricitabine.
The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278 given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily, when combined with a fixed background regimen…
- Conditions
- HIV Infections, HIV-1, Human Immunodeficiency Virus Type 1
- Trial name
- NCT00540449
- Testing
- TMC278, Efavirenz
- Where
- 92 sites in United States, Argentina and 18 more
- Volunteers
- 694 people
- 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
Human Immunodeficiency Virus Type 1
A Study of TMC278 in Human Immunodeficiency Virus Type 1 Infected Patients, Who Are Not Treated With Antiretroviral Medicines
The purpose of this study is to evaluate the dose-response relationship of antiviral activity after 48 weeks treatment with 3 different dose regimens of TMC278.
- Trial name
- NCT00110305
- Testing
- TMC278 25 mg, TMC278 75 mg, TMC278 150 mg
- Where
- 40 sites in United States, Argentina and 12 more
- Volunteers
- 368 people
- 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-1)
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
- NCT02429791
- Testing
- DTG 50 mg, RPV 25 mg, CAR
- Where
- 65 sites in United States, Argentina and 11 more
- Volunteers
- 510 people
- Sponsor
- ViiV Healthcare
HIV Infections
Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults
This Antiretroviral Therapy as Long Acting Suppression every 2 Months (ATLAS-2M) study is designed to demonstrate the non-inferior antiviral activity and safety of CAB LA + RPV LA administered every 8 weeks (Q8W) compared to CAB…
- Trial name
- ATLAS-2M (NCT03299049)
- Testing
- Cabotegravir Tablets, Rilpivirine Tablets, Cabotegravir Injectable Suspension
- Where
- 119 sites in United States, Argentina and 11 more
- Volunteers
- 1,049 people
- Sponsor
- ViiV Healthcare
HIV Infections
A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed
This study is designed to assess the antiviral activity and safety of a two-drug regimen of CAB LA + RPV LA compared with maintenance of BIK. BIKTARVY is a registered trademark of Gilead Sciences.
- Trial name
- SOLAR (NCT04542070)
- Testing
- Cabotegravir Tablets, Cabotegravir Injectable Suspension (CAB LA), Rilpivirine Tablets
- Where
- 117 sites in United States, Australia and 12 more
- Volunteers
- 687 people
- Sponsor
- ViiV Healthcare
HIV, HIV Infections
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
The purpose of this study is to study how changes in the body during pregnancy influence the blood levels of TMC114 (darunavir) and ritonavir taken together, darunavir and cobicistat taken as a fixed-dose combination, TMC125…
- Conditions
- HIV, HIV Infections, Pregnancy
- Trial name
- NCT00855335
- Testing
- Darunavir, Ritonavir, Etravirine
- Where
- 17 sites in United States, Puerto Rico
- Volunteers
- 77 people
- Sponsor
- Janssen Scientific Affairs, LLC
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
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
HIV-1 Infection, HCV Infection
Efficacy, Safety, and Tolerability of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Participants Who Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Emtricitabine/Rilpivirine/Tenofovir Alafenamide (F/R/TAF) Prior to LDV/SOF HCV Treatment
This study will evaluate efficacy of ledipasvir/sofosbuvir (LDV/SOF) and safety and tolerability of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) or emtricitabine/rilpivirine/tenofovir…
- Trial name
- Co-STARs (NCT02707601)
- Testing
- E/C/F/TAF, F/R/TAF, LDV/SOF
- Where
- 43 sites in United States, Puerto Rico
- Volunteers
- 150 people
- Sponsor
- Gilead Sciences
HIV Infections, HIV-1
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
The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278 given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily, when combined with a background regimen…
- Trial name
- NCT00543725
- Testing
- TMC278, efavirenz
- Where
- 82 sites in United States, Australia and 18 more
- Volunteers
- 680 people
- 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