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- | Edurant (rilpivirine) / J&J, Complera (emtricitabine/rilpivirine/tenofovir) / Gilead, J&J
New P4 trial: SSAT058: Atripla to Eviplera Switch in Patients Without Central Nervous System Symptoms (clinicaltrials.gov) - Aug 19, 2015
P4, N=40, Not yet recruiting, Sponsor: St Stephens Aids Trust
- | Edurant (rilpivirine) / J&J
New P2 trial: A Roll-over Study With Rilpivirine for Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Who Participated in Rilpivirine Pediatric Studies (clinicaltrials.gov) - Jul 13, 2015
P2, N=100, Not yet recruiting, Sponsor: Janssen R&D Ireland
- Edurant (rilpivirine) / J&J
Enrollment change, Trial withdrawal: Safety, Tolerability, Drug Interactions, and Antiviral Activity of Rilpivirine in Antiretroviral-Naive HIV-Infected Children Less Than 12 Years of Age (clinicaltrials.gov) - Jul 6, 2015
P1/2, N=0, Withdrawn, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
N=60 --> 0 | Active, not recruiting --> Withdrawn
- Complera (emtricitabine/rilpivirine/tenofovir) / Gilead, J&J
Enrollment open, Adverse events: DeepSwitch: Decrease of Neuropsychiatric Side Effects After Switching From Atripla to Eviplera (clinicaltrials.gov) - Jun 17, 2015
P4, N=40, Recruiting, Sponsor: Sheba Medical Center
N=60 --> 0 | Active, not recruiting --> Withdrawn Not yet recruiting --> Recruiting
- | Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) / Gilead, Japan Tobacco
New P4 trial, HEOR: Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive (clinicaltrials.gov) - Jun 12, 2015
P4, N=150, Not yet recruiting, Sponsor: Juan A. Arnaiz
- Complera (emtricitabine/rilpivirine/tenofovir) / Gilead, J&J
New P4 trial, Adverse events: DeepSwitch: Decrease of Neuropsychiatric Side Effects After Switching From Atripla to Eviplera (clinicaltrials.gov) - May 19, 2015
P4, N=40, Not yet recruiting, Sponsor: Sheba Medical Center
- | Edurant (rilpivirine) / J&J
New P4 trial, Combination therapy: PREZENT: Open Label, Pilot Study of Darunavir Boosted by Cobicistat in Combination With Rilpivirine to Treat HIV+ Na (clinicaltrials.gov) - Mar 31, 2015
P4, N=30, Not yet recruiting, Sponsor: Therapeutic Concepts
- ||||| Edurant (rilpivirine) / J&J, Prezcobix (darunavir/cobicistat) / Gilead, J&J, Intelence (etravirine) / J&J
Enrollment change, Trial primary completion date: 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 (clinicaltrials.gov) - Mar 25, 2015
P3, N=80, Recruiting, Sponsor: Janssen Scientific Affairs, LLC
Not yet recruiting --> Recruiting N=50 --> 80 | Trial primary completion date: Aug 2016 --> May 2017
- | Edurant (rilpivirine) / J&J
Trial completion: Efavirenz Versus Rilpivirine on Vascular Function, Inflammation, and Oxidative Stress (clinicaltrials.gov) - Mar 24, 2015
P4, N=40, Completed, Sponsor: Indiana University
N=50 --> 80 | Trial primary completion date: Aug 2016 --> May 2017 Active, not recruiting --> Completed
- Edurant (rilpivirine) / J&J
Enrollment closed: Safety, Tolerability, Drug Interactions, and Antiviral Activity of Rilpivirine in Antiretroviral-Naive HIV-Infected Children Less Than 12 Years of Age (clinicaltrials.gov) - Feb 24, 2015
P1/2, N=60, Active, not recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Active, not recruiting --> Completed Not yet recruiting --> Active, not recruiting
- Edurant (rilpivirine) / J&J, Rekambys (rilpivirine LA) / J&J
Enrollment open: Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278LA, for Pre-Exposure Prophylaxis (clinicaltrials.gov) - Feb 23, 2015
P2, N=132, Recruiting, Sponsor: PATH
Not yet recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- | Enrollment open: TRULIGHT: Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy (clinicaltrials.gov) - Feb 19, 2015
P3, N=250, Recruiting, Sponsor: University Hospital, Tours
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- Edurant (rilpivirine) / J&J, Complera (emtricitabine/rilpivirine/tenofovir) / Gilead, J&J
Trial completion, Enrollment change: EPEP: Safety, Tolerability,and Adherence to Co-formulated Tenofovir-emtricitabine-rilpivirine Used as HIV Nonoccupational Post-exposure Prophylaxis in Men Who Have Sex With Men. (clinicaltrials.gov) - Jan 12, 2015
P4, N=100, Completed, Sponsor: Andrew Carr
Not yet recruiting --> Recruiting Recruiting --> Completed | N=50 --> 100
- || New P3 trial: TRULIGHT: Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy (clinicaltrials.gov) - Nov 28, 2014
P3, N=250, Not yet recruiting, Sponsor: University Hospital, Tours
- Edurant (rilpivirine) / J&J
Trial primary completion date: Safety, Tolerability, Drug Interactions, and Antiviral Activity of Rilpivirine in Antiretroviral-Naive HIV-Infected Children Less Than 12 Years of Age (clinicaltrials.gov) - Oct 30, 2014
P1/2, N=60, Not yet recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Recruiting --> Completed | N=50 --> 100 Trial primary completion date: Sep 2016 --> May 2018
- | Enrollment closed, Trial primary completion date: 4 Consecutive Days on Treatment Followed by 3 Days Off Treatment, in HIV Patients (clinicaltrials.gov) - Oct 30, 2014
P3, N=100, Active, not recruiting, Sponsor: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Trial primary completion date: Sep 2016 --> May 2018 Recruiting --> Active, not recruiting | Trial primary completion date: Jul 2016 --> Jan 2016
- ||||| Edurant (rilpivirine) / J&J, Complera (emtricitabine/rilpivirine/tenofovir) / Gilead, J&J
Enrollment closed, Head-to-Head: SALIF: A Clinical Trial Comparing the Efficacy of Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus TDF/FTC/Efavirenz (TDF/FTC/EFV) in Patients With Undetectable Plasma HIV-1 RNA on Current First-line Treatment (clinicaltrials.gov) - Oct 28, 2014
P3, N=427, Active, not recruiting, Sponsor: Janssen-Cilag International NV
Recruiting --> Active, not recruiting | Trial primary completion date: Jul 2016 --> Jan 2016 Recruiting --> Active, not recruiting
- | Edurant (rilpivirine) / J&J
Enrollment open, Trial initiation date, Trial primary completion date: DRV/r + RPV QD: Efficacy and Toxicity Reduction (clinicaltrials.gov) - Oct 11, 2014
P3, N=132, Recruiting, Sponsor: Ospedale L. Sacco
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting | Initiation date: Mar 2013 --> Sep 2014 | Trial primary completion date: Mar 2015 --> Sep 2016
- Edurant (rilpivirine) / J&J, Rekambys (rilpivirine LA) / J&J
Trial primary completion date: Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278LA, for Pre-Exposure Prophylaxis (clinicaltrials.gov) - Sep 28, 2014
P2, N=132, Not yet recruiting, Sponsor: PATH
Not yet recruiting --> Recruiting | Initiation date: Mar 2013 --> Sep 2014 | Trial primary completion date: Mar 2015 --> Sep 2016 Trial primary completion date: Oct 2016 --> Oct 2017
- ||| Vocabria (cabotegravir oral) / ViiV Healthcare
Enrollment closed: LATTE-2: 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 (clinicaltrials.gov) - Aug 19, 2014
P2b, N=265, Active, not recruiting, Sponsor: ViiV Healthcare
Trial primary completion date: Oct 2016 --> Oct 2017 Recruiting --> Active, not recruiting
- |||| Edurant (rilpivirine) / J&J, Complera (emtricitabine/rilpivirine/tenofovir) / Gilead, J&J
Trial primary completion date, Head-to-Head: SALIF: A Clinical Trial Comparing the Efficacy of Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus TDF/FTC/Efavirenz (TDF/FTC/EFV) in Patients With Undetectable Plasma HIV-1 RNA on Current First-line Treatment (clinicaltrials.gov) - Aug 15, 2014
P3, N=426, Recruiting, Sponsor: Janssen-Cilag International NV
Recruiting --> Active, not recruiting Trial primary completion date: Jul 2014 --> Oct 2015
- | Enrollment open: 4 Consecutive Days on Treatment Followed by 3 Days Off Treatment, in HIV Patients (clinicaltrials.gov) - Aug 1, 2014
P3, N=100, Recruiting, Sponsor: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Trial primary completion date: Jul 2014 --> Oct 2015 Not yet recruiting --> Recruiting
- Edurant (rilpivirine) / J&J
Trial primary completion date, IO biomarker: 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 (clinicaltrials.gov) - Jun 27, 2014
P2, N=36, Active, not recruiting, Sponsor: Janssen R&D Ireland
Not yet recruiting --> Recruiting Trial primary completion date: May 2014 --> Aug 2014
- | Edurant (rilpivirine) / J&J, Rekambys (rilpivirine LA) / J&J
New P2 trial: Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278LA, for Pre-Exposure Prophylaxis (clinicaltrials.gov) - Jun 18, 2014
P2, N=132, Not yet recruiting, Sponsor: PATH
- || New P3 trial: 4 Consecutive Days on Treatment Followed by 3 Days Off Treatment, in HIV Patients (clinicaltrials.gov) - Jun 4, 2014
P3, N=100, Not yet recruiting, Sponsor: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
- || Vocabria (cabotegravir oral) / ViiV Healthcare
Combination therapy: Dose Ranging Study of GSK1265744 Plus Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus-1 (HIV-1) Virologic Suppression Followed by Virologic Suppression Maintenance by GSK1265744 Plus Rilpivirine (clinicaltrials.gov) - May 21, 2014
P2b, N=244, Active, not recruiting, Sponsor: ViiV Healthcare
Trial primary completion date: May 2014 --> Aug 2014 Trial primary completion date: Dec 2014 --> Oct 2013
- || Vocabria (cabotegravir oral) / ViiV Healthcare
Combination therapy: Dose Ranging Study of GSK1265744 Plus Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus-1 (HIV-1) Virologic Suppression Followed by Virologic Suppression Maintenance by GSK1265744 Plus Rilpivirine (clinicaltrials.gov) - May 21, 2014
P2b, N=244, Active, not recruiting, Sponsor: ViiV Healthcare
Trial primary completion date: Dec 2014 --> Oct 2013 Trial completion date: Dec 2016 --> Dec 2020
- |||| Vocabria (cabotegravir oral) / ViiV Healthcare
Enrollment open: LATTE-2: 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 (clinicaltrials.gov) - May 14, 2014
P2b, N=265, Recruiting, Sponsor: ViiV Healthcare
Trial completion date: Dec 2016 --> Dec 2020 Not yet recruiting --> Recruiting
- | Edurant (rilpivirine) / J&J
Trial completion: The Rilpivirine Cerebrospinal-fluid (CSF) Study (clinicaltrials.gov) - May 1, 2014
P1, N=14, Completed, Sponsor: Imperial College London
Not yet recruiting --> Recruiting Recruiting --> Completed
- | Edurant (rilpivirine) / J&J
Enrollment closed: Efavirenz Versus Rilpivirine on Vascular Function, Inflammation, and Oxidative Stress (clinicaltrials.gov) - Apr 27, 2014
P4, N=40, Active, not recruiting, Sponsor: Indiana University
Recruiting --> Completed Recruiting --> Active, not recruiting
- |||||| Vocabria (cabotegravir oral) / ViiV Healthcare
New P2b trial: LATTE-2: 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 (clinicaltrials.gov) - Apr 20, 2014
P2b, N=265, Not yet recruiting, Sponsor: ViiV Healthcare
- Edurant (rilpivirine) / J&J, Complera (emtricitabine/rilpivirine/tenofovir) / Gilead, J&J
Trial initiation date, Adherence: EPEP: Safety, Tolerability,and Adherence to Co-formulated Tenofovir-emtricitabine-rilpivirine Used as HIV Nonoccupational Post-exposure Prophylaxis in Men Who Have Sex With Men. (clinicaltrials.gov) - Apr 14, 2014
P4, N=50, Recruiting, Sponsor: Andrew Carr
Recruiting --> Active, not recruiting Initiation date: Nov 2012 --> Dec 2012
- Edurant (rilpivirine) / J&J, Complera (emtricitabine/rilpivirine/tenofovir) / Gilead, J&J
Enrollment open, Adherence: EPEP: Safety, Tolerability,and Adherence to Co-formulated Tenofovir-emtricitabine-rilpivirine Used as HIV Nonoccupational Post-exposure Prophylaxis in Men Who Have Sex With Men. (clinicaltrials.gov) - Apr 14, 2014
P4, N=50, Recruiting, Sponsor: Andrew Carr
Initiation date: Nov 2012 --> Dec 2012 Not yet recruiting --> Recruiting
- ||| Vocabria (cabotegravir oral) / ViiV Healthcare
Combination therapy: Dose Ranging Study of GSK1265744 Plus Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus-1 (HIV-1) Virologic Suppression Followed by Virologic Suppression Maintenance by GSK1265744 Plus Rilpivirine (clinicaltrials.gov) - Mar 12, 2014
P2b, N=244, Active, not recruiting, Sponsor: ViiV Healthcare
Not yet recruiting --> Recruiting N=200 --> 244
- ||||| Edurant (rilpivirine) / J&J, Complera (emtricitabine/rilpivirine/tenofovir) / Gilead, J&J
New P4 trial, Adverse events: SWEAR: Switching From Efavirenz/Atripla to Rilpivirine Among Patients With Neurocognitive or Neuropsychological Side Effects (clinicaltrials.gov) - Jan 20, 2014
P4, N=90, Not yet recruiting, Sponsor: Azienda Ospedaliera San Gerardo di Monza
- | Edurant (rilpivirine) / J&J
New P1/2 trial: Safety, Tolerability, Drug Interactions, and Antiviral Activity of Rilpivirine in Antiretroviral-Naive HIV-Infected Children Less Than 12 Years of Age (clinicaltrials.gov) - Oct 31, 2013
P1/2, N=60, Not yet recruiting, Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
- |||||| Edurant (rilpivirine) / J&J, Complera (emtricitabine/rilpivirine/tenofovir) / Gilead, J&J
Enrollment open, Head-to-Head: SALIF: A Clinical Trial Comparing the Efficacy of Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus TDF/FTC/Efavirenz (TDF/FTC/EFV) in Patients With Undetectable Plasma HIV-1 RNA on Current First-line Treatment (clinicaltrials.gov) - Oct 28, 2013
P3, N=426, Recruiting, Sponsor: Janssen-Cilag International NV
N=200 --> 244 Not yet recruiting --> Recruiting
- Edurant (rilpivirine) / J&J
Trial withdrawal: A Study on the Safety and Effectiveness of Rilpivirine Hydrochloride (Edurant) Among Adult Filipino Patients With Human Immunodeficiency Virus Type-I Infection (clinicaltrials.gov) - Sep 23, 2013
P4, N=0, Withdrawn, Sponsor: Janssen Pharmaceutica
Not yet recruiting --> Recruiting Not yet recruiting --> Withdrawn
- Edurant (rilpivirine) / J&J
Enrollment change: A Study on the Safety and Effectiveness of Rilpivirine Hydrochloride (Edurant) Among Adult Filipino Patients With Human Immunodeficiency Virus Type-I Infection (clinicaltrials.gov) - Sep 23, 2013
P4, N=0, Withdrawn, Sponsor: Janssen Pharmaceutica
Not yet recruiting --> Withdrawn N=60 --> 0
- | Edurant (rilpivirine) / J&J
Enrollment closed, IO biomarker: 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 (clinicaltrials.gov) - Sep 10, 2013
P2, N=36, Active, not recruiting, Sponsor: Janssen R&D Ireland
N=60 --> 0 Recruiting --> Active, not recruiting
- Edurant (rilpivirine) / J&J
Trial completion: Pharmacokinetics of Tenofovir and Tenofovir-diphosphate, Emtricitabine and Emtricitabine-triphosphate, and Rilpivirine Once Daily Over 14 Days Following Drug Intake Cessation in Healthy Volunteers (clinicaltrials.gov) - Jul 23, 2013
P1, N=18, Completed, Sponsor: St Stephens Aids Trust
Recruiting --> Active, not recruiting Recruiting --> Completed
- Edurant (rilpivirine) / J&J
Trial completion: A Single-Dose Pharmacokinetics and Safety Study of TMC278 in Healthy Adult Japanese Participants (clinicaltrials.gov) - May 22, 2013
P4, N=8, Completed, Sponsor: Janssen Pharmaceutical K.K.
Recruiting --> Completed Not yet recruiting --> Completed
- Edurant (rilpivirine) / J&J
New P4 trial: A Single-Dose Pharmacokinetics and Safety Study of TMC278 in Healthy Adult Japanese Participants (clinicaltrials.gov) - Mar 3, 2013
P4, N=8, Completed, Sponsor: Janssen Pharmaceutical K.K.
- Edurant (rilpivirine) / J&J
New P1 trial: Pharmacokinetics of Tenofovir and Tenofovir-diphosphate, Emtricitabine and Emtricitabine-triphosphate, and Rilpivirine Once Daily Over 14 Days Following Drug Intake Cessation in Healthy Volunteers (clinicaltrials.gov) - Feb 19, 2013
P1, N=18, Completed, Sponsor: St Stephens Aids Trust
- Edurant (rilpivirine) / J&J, Complera (emtricitabine/rilpivirine/tenofovir) / Gilead, J&J
Enrollment closed: A Pilot Study to Assess the Feasibility of Switching, Individuals Receiving Atripla With Continuing Central Nervous System (CNS) Toxicity, to a Fixed Dose Combination of Tenofovir/Emtricitabine/Rilpivirine (clinicaltrials.gov) - Feb 19, 2013
P3, N=0, Active, not recruiting, Sponsor: St Stephens Aids Trust
Not yet recruiting --> Completed Recruiting --> Active, not recruiting
- || Edurant (rilpivirine) / J&J
New P3 trial: DRV/r + RPV QD: Efficacy and Toxicity Reduction (clinicaltrials.gov) - Feb 13, 2013
P3, N=132, Not yet recruiting, Sponsor: Ospedale L. Sacco
- | Edurant (rilpivirine) / J&J
Trial completion: A Study to Explore Pharmacokinetic Interaction Between Rilpivirine and Metformin in Healthy Participants (clinicaltrials.gov) - Feb 12, 2013
P1, N=20, Completed, Sponsor: Janssen R&D Ireland
Recruiting --> Active, not recruiting Recruiting --> Completed
- | Edurant (rilpivirine) / J&J
Trial initiation date, IO biomarker: 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 (clinicaltrials.gov) - Dec 13, 2012
P2, N=36, Active, not recruiting, Sponsor: Janssen R&D Ireland
Recruiting --> Completed Initiation date: May 2009 --> Jan 2011
- Edurant (rilpivirine) / J&J
Enrollment open: A Phase IV, Open-label Single-arm Study Investigating the Pharmacokinetics and Pharmacodynamics of the Antiretroviral Combination of Rilpivirine and Ritonavirboosted Darunavir in Therapy-naive HIV-1 Infected Patients. (clinicaltrials.gov) - Dec 9, 2012
P4, N=40, Recruiting, Sponsor: St Stephens Aids Trust
Initiation date: May 2009 --> Jan 2011 Not yet recruiting --> Recruiting
- ||| Vocabria (cabotegravir oral) / ViiV Healthcare
Enrollment closed, Combination therapy: Dose Ranging Study of GSK1265744 Plus Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus-1 (HIV-1) Virologic Suppression Followed by Virologic Suppression Maintenance by GSK1265744 Plus Rilpivirine (clinicaltrials.gov) - Dec 5, 2012
P2b, N=244, Active, not recruiting, Sponsor: ViiV Healthcare
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting