Clinical Trials

Numerous clinical trials evaluate Rilpivirine across Phase 1 through Phase 4, focusing primarily on HIV-1 infection, controlled viremia, and healthy subjects, while exploring secondary areas such as neurocognitive dysfunction, fatty liver disease, contraception, and drug-drug interactions. Sponsored by various pharmaceutical companies and academic entities, these studies range from single-dose pharmacokinetics to long-acting antiretroviral regimens. Across these investigations, recruitment statuses include recruiting, active not recruiting, and completed.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07650916 RECRUITING
HIV Infections
ViiV Healthcare
 2026-06-25 PHASE3
NCT07682961 RECRUITING
HIV Infections
Gilead Sciences
 2026-07-14 PHASE3
NCT07637877 RECRUITING
Immunological Non-Responders in People With HIV
Beijing 302 Hospital
 2026-06-15 PHASE2
NCT07727642 RECRUITING
AIDS-related Lymphoma; HIV Infection
Shanghai Public Health Clinical Center
 2026-05-26
NCT06336434 WITHDRAWN
HIV-1-infection; Pregnancy; Postpartum
National Institute of Allergy and Infectious Diseases (NIAID)
 2025-05-01 PHASE1; PHASE2
NCT05044962 RECRUITING
HIV Infections; Contraception; Drug-drug Interaction
University of Alabama at Birmingham
 2021-11-26
NCT06411223 ACTIVE_NOT_RECRUITING
Hiv
Yale University
 2024-08-01 PHASE2
NCT05660980 RECRUITING
HIV-1-infection
National Institute of Allergy and Infectious Diseases (NIAID)
 2024-01-24 PHASE1; PHASE2
NCT02494986 ACTIVE_NOT_RECRUITING
Human Immunodeficiency Virus Type 1
Janssen Sciences Ireland UC
 2015-07-06 PHASE2
NCT06834113 RECRUITING
HIV I Infection; Injection Pain
Centre Hospitalier Régional d'Orléans
 2025-01-24
NCT05674656 RECRUITING
HIV Infections
ViiV Healthcare
 2023-07-06 PHASE1; PHASE2
NCT06646562 RECRUITING
HIV-1 Infected Adults with Controlled Viremia
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
 2025-03-03 PHASE4
NCT05917509 COMPLETED
HIV Infections
ViiV Healthcare
 2023-07-06 PHASE3
NCT05898841 COMPLETED
HIV Infections; Fatty Liver Disease
Fundacion SEIMC-GESIDA
 2023-05-26 PHASE4
NCT06507059 RECRUITING
HIV-1-infection; Non-Adherence, Medication
Chang Gung Memorial Hospital
 2024-07-19 PHASE3
NCT06185452 COMPLETED
HIV-1 Infection
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
 2023-09-26 PHASE4
NCT06159894 COMPLETED
HIV Infections
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
 2023-12-18
NCT05601128 COMPLETED
HIV-1-infection; HIV Infections; HIV I Infection
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
 2023-01-01 PHASE3
NCT05546242 ACTIVE_NOT_RECRUITING
HIV-1-infection
MRC/UVRI and LSHTM Uganda Research Unit
 2022-12-08 PHASE3
NCT05154747 UNKNOWN
Hiv; HIV Infections; HIV-1-infection; Paediatric Human Immunodeficiency Virus Infection
University College, London
 2023-06-22 PHASE3
NCT05156658 WITHDRAWN
HIV-1-infection
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
 2024-01-01 PHASE4
NCT05112939 COMPLETED
Healthy
Janssen Research & Development, LLC
 2021-11-16 PHASE1
NCT05096949 TERMINATED
HIV-1-infection; Medication Adherence; Satisfaction, Patient
University of Arkansas
 2022-03-07
NCT06104306 Recruiting
HIV-1-infection
Gilead Sciences
 2023-12-13 Phase 4
NCT05896748 COMPLETED
Human Immunodeficiency Virus Type 1 (HIV-1)
ViiV Healthcare
 2022-11-08 PHASE3
NCT04431518 COMPLETED
HIV/AIDS; ESRD
Indiana University
 2021-04-23 PHASE4
NCT04973254 COMPLETED
HIV Infections
Boston Medical Center
 2022-02-23
NCT03497676 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2019-04-03 PHASE1; PHASE2
NCT04012931 COMPLETED
HIV
Janssen Research & Development, LLC
 2019-07-18 PHASE2
NCT05601128 Active not recruiting
HIV-1-infection|HIV Infections|HIV I Infection
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
 2023-01-01 Phase 3
NCT05896761 COMPLETED
Human Immunodeficiency Virus Type 1 (HIV-1)
ViiV Healthcare
 2021-10-28 PHASE3
NCT00799864 COMPLETED
HIV-1
Janssen Sciences Ireland UC
 2011-01 PHASE2
NCT04542070 COMPLETED
HIV Infections
ViiV Healthcare
 2020-11-09 PHASE3
NCT07001488 COMPLETED
Healthy
Henan Genuine Biotech Co., Ltd.
 2022-02-21 PHASE1
NCT04399551 COMPLETED
HIV Infections
ViiV Healthcare
 2020-09-28 PHASE3
NCT04371380 COMPLETED
HIV Infections
ViiV Healthcare
 2020-09-16 PHASE1
NCT05358756 COMPLETED
Healthy Subject
Aptorum International Limited
 2021-10-09 PHASE1
NCT05349838 COMPLETED
HIV-1-infection
NEAT ID Foundation
 2018-11-05 PHASE3
NCT04538040 COMPLETED
HIV-1-infection
Quest Clinical Research
 2019-12-19 PHASE4
NCT05112939 Active not recruiting
Healthy
Janssen Research & Development LLC
 2021-11-16 Phase 1
NCT05358756 Completed
Healthy Subject
Aptorum International Limited
 2021-10-09 Phase 1
NCT03563742 TERMINATED
Human Immunodeficiency Virus Infections
Janssen Research & Development, LLC
 2018-09-24 PHASE3
NCT04001803 COMPLETED
HIV Infections
ViiV Healthcare
 2019-07-08 PHASE3
NCT03567304 UNKNOWN
HIV-1-infection; Neurocognitive Dysfunction
Chiang Mai University
 2018-07-06 PHASE4
NCT04281459 COMPLETED
HIV-1-infection
Azienda Ospedaliera Universitaria Integrata Verona
 2020-03-01
NCT01266902 COMPLETED
HIV-1 Infection
Janssen R&D Ireland
 2011-02 PHASE3
NCT03639311 COMPLETED
HIV Infections
ViiV Healthcare
 2018-09-24 PHASE2
NCT03984838 COMPLETED
HIV Infections
ViiV Healthcare
 2019-06-17 PHASE1
NCT04064632 UNKNOWN
HIV Infection
A.O. Ospedale Papa Giovanni XXIII
 2017-02-01 PHASE4
NCT03299049 ACTIVE_NOT_RECRUITING
HIV Infections
ViiV Healthcare
 2017-10-27 PHASE3
NCT03589040 UNKNOWN
HIV; Contraception
Makerere University
 2018-09-25 PHASE2
NCT03589027 UNKNOWN
HIV-1-infection; Contraception
Makerere University
 2018-08-07 PHASE2
NCT01792570 COMPLETED
Human Immunodeficiency Virus
ASST Fatebenefratelli Sacco
 2014-09-30 PHASE3
NCT02938520 ACTIVE_NOT_RECRUITING
HIV Infections
ViiV Healthcare
 2016-10-27 PHASE3
NCT02951052 ACTIVE_NOT_RECRUITING
Infection, Human Immunodeficiency Virus; HIV Infections
ViiV Healthcare
 2016-10-28 PHASE3
NCT01975012 WITHDRAWN
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2014-09 PHASE1; PHASE2
NCT03251690 COMPLETED
Anti-Retroviral Agents; Efavirenz; HIV-1-infection; Sustained Virologic Response; Dyslipidemias; Rilpivirine
Mahidol University
 2016-10-27
NCT03127189 COMPLETED
Healthy
Janssen Research & Development, LLC
 2017-04-20 PHASE1
NCT03664440 COMPLETED
Efficacy of Rilpivirine-based Regimens as Switch Therapy
Mahidol University
 2016-12-01
NCT02069834 WITHDRAWN
HIV Infection; HAART-treated; Virologically Controlled
Nantes University Hospital
 2014-05 PHASE2; PHASE3
NCT02707601 COMPLETED
HIV-1 Infection; HCV Infection
Gilead Sciences
 2016-04-01 PHASE3
NCT02042001 COMPLETED
Impaired Cognition; Depression/Anxiety; Poor Quality Sleep; Quality of Life; HIV-1 Infection
Azienda Ospedaliera San Gerardo di Monza
 2015-07-01 PHASE4
NCT02470650 WITHDRAWN
Patient Compliance; Antiretroviral Therapy Intolerance
Juan A. Arnaiz
 2015-06 PHASE4
NCT03033368 UNKNOWN
HIV
Mahidol University
 2015-07 PHASE2; PHASE3
NCT02529059 COMPLETED
HIV
St Stephens Aids Trust
 2015-11 PHASE4
NCT02447016 TERMINATED
HIV
Sheba Medical Center
 2015-05 PHASE4
NCT02741557 COMPLETED
Infection, Human Immunodeficiency Virus; HIV Infections
ViiV Healthcare
 2016-05-11 PHASE1
NCT02478632 COMPLETED
HIV Infections
ViiV Healthcare
 2015-06-12 PHASE3
NCT02422797 COMPLETED
HIV Infections
ViiV Healthcare
 2015-04-21 PHASE3
NCT02429791 COMPLETED
HIV Infections
ViiV Healthcare
 2015-04-14 PHASE3
NCT02404233 UNKNOWN
HIV Positive
Therapeutic Concepts
 2015-03 PHASE4
NCT00855335 COMPLETED
HIV; HIV Infections; Pregnancy
Janssen Scientific Affairs, LLC
 2009-04-09 PHASE3
NCT02345226 COMPLETED
HIV-1 Infection
Gilead Sciences
 2015-01-26 PHASE3
NCT02345252 COMPLETED
HIV-1 Infection
Gilead Sciences
 2015-01-26 PHASE3
NCT02104700 COMPLETED
HIV
Philip Grant
 2014-04 PHASE2; PHASE3
NCT02547870 COMPLETED
Human Immunodeficiency Virus Type 1
Janssen Infectious Diseases BVBA
 2015-08-14 PHASE1
NCT02561936 COMPLETED
Healthy
Janssen Sciences Ireland UC
 2015-10 PHASE1
NCT01777997 COMPLETED
HIV-1 Infection
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
 2013-04-25 PHASE4
NCT01709084 COMPLETED
Human Immunodeficiency Virus-type 1 Infection
Janssen-Cilag International NV
 2013-10-02 PHASE3
NCT02373930 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2015-02 PHASE1
NCT02530060 COMPLETED
Healthy
Janssen Pharmaceutical K.K.
 2015-08 PHASE4
NCT02165202 COMPLETED
Human Immunodeficiency Virus (HIV)
PATH
 2014-10 PHASE2
NCT01736761 COMPLETED
HIV
St Stephens Aids Trust
 2012-12 PHASE4
NCT01715636 COMPLETED
HIV Nonoccupational Post-exposure Prophylaxis in Men Who Have Sex With Men
Andrew Carr
 2012-12 PHASE4
NCT01585038 COMPLETED
Cardiovascular Disease
Indiana University
 2012-07 PHASE4
NCT01701882 COMPLETED
HIV
St Stephens Aids Trust
 2012-09 PHASE3
NCT01641809 COMPLETED
Infection, Human Immunodeficiency Virus; HIV Infections
ViiV Healthcare
 2012-08-06 PHASE2
NCT01796431 COMPLETED
HIV
St Stephens Aids Trust
 2013-03 PHASE1
NCT01719614 COMPLETED
Healthy Participants
Janssen R&D Ireland
 2012-10 PHASE1
NCT01562886 COMPLETED
HIV
Imperial College London
 2012-03 PHASE1
NCT01309243 COMPLETED
HIV-1 Infection
Gilead Sciences
 2011-02 PHASE3
NCT01615614 COMPLETED
Healthy
Janssen R&D Ireland
 2012-04 PHASE1
NCT01467531 COMPLETED
Infections, Human Immunodeficiency Virus and Hepatitis
ViiV Healthcare
 2011-11 PHASE1
NCT01252940 COMPLETED
HIV-1 Infection
Gilead Sciences
 2010-11 PHASE3
NCT01031589 COMPLETED
HIV Infections
Tibotec Pharmaceuticals, Ireland
 2010-01 PHASE1
NCT01286740 COMPLETED
HIV-1 Infection
Gilead Sciences
 2011-01 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-14)

Check the Rilpivirine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rilpivirine is a non-nucleoside reverse transcriptase inhibitor that specifically binds to the hydrophobic pocket adjacent to the active catalytic site of human immunodeficiency virus type 1 (HIV-1) reverse transcriptase, inducing a conformational change that suppresses DNA polymerase activity. By blocking viral RNA-dependent DNA synthesis, the compound prevents viral replication in host lymphocytes, providing clinical efficacy in the treatment of HIV-1 infection.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.