Clinical Trials

Numerous clinical trials have evaluated etravirine across Phase 1 through Phase 4, primarily focusing on the treatment of HIV/AIDS, HIV-1 infection, and hepatitis C co-infection in diverse patient populations. Conducted by pharmaceutical companies, research foundations, and academic institutions, these studies encompass early pharmacokinetic, pediatric, safety, and long-term outcome evaluations. Overall recruitment statuses reflect a mix of completed, active not recruiting, terminated, and withdrawn protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05506605 UNKNOWN
HIV-1-infection
Fundacion Clinic per a la Recerca Biomédica
 2022-12-12 PHASE4
NCT04273165 COMPLETED
Friedreich Ataxia
IRCCS Eugenio Medea
 2020-09-17 PHASE2
NCT04334551 UNKNOWN
HIV Infections
Clinique du Quartier Latin
 2020-06-23 PHASE4
NCT04630002 COMPLETED
HIV Infections
ViiV Healthcare
 2020-10-28 PHASE1
NCT00980538 COMPLETED
HIV Infections; HIV-1
Janssen Sciences Ireland UC
 2009-12-09 PHASE3
NCT04208373 COMPLETED
Healthy
Janssen Research & Development, LLC
 2019-12-20 PHASE1
NCT04194021 Active not recruiting
HIV/AIDS
Elizabeth Glaser Pediatric AIDS Foundation|Janssen LP
 2019-01-01 --
NCT01504841 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2013-03-14 PHASE1; PHASE2
NCT02212379 COMPLETED
HIV-1 Infection
ANRS, Emerging Infectious Diseases
 2015-01 PHASE2
NCT01641367 COMPLETED
HIV-1 Infection
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
 2013-02-22 PHASE4
NCT02818348 COMPLETED
HIV-1 Infection
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
 2016-06 PHASE1
NCT00855335 COMPLETED
HIV; HIV Infections; Pregnancy
Janssen Scientific Affairs, LLC
 2009-04-09 PHASE3
NCT02818348 Completed
HIV-1 Infection
Fundación FLS de Lucha Contra el Sida las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
 2016-06 Phase 1
NCT02063360 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2014-02-01 PHASE1
NCT00959894 COMPLETED
HIV Infections
University of North Carolina, Chapel Hill
 2009-09 PHASE2
NCT01422330 COMPLETED
Human Immunodeficiency Virus (HIV) Infection
Janssen R&D Ireland
 2011-09 PHASE4
NCT00855413 TERMINATED
Acute HIV Infection; HIV Infections
University of North Carolina, Chapel Hill
 2009-03 PHASE4
NCT01543035 COMPLETED
HIV Infection
Calmy Alexandra
 2011-12 PHASE3
NCT01118871 TERMINATED
HIV; HIV Infections
Imperial College London
 2010-05 PHASE4
NCT01254656 TERMINATED
HIV-1
Pfizer
 2011-02 PHASE2
NCT01625169 COMPLETED
HIV
University of Southern California
 2010-04
NCT00823979 TERMINATED
HIV-1
Pfizer
 2009-03-25 PHASE2
NCT01199939 COMPLETED
Human Immunodeficiency Virus (HIV)
Tibotec, Inc
 2010-05 PHASE2
NCT00537394 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2008-01 PHASE3
NCT00896051 COMPLETED
HIV Infections; Acquired Immunodeficiency Syndrome
Janssen R&D Ireland
 2009-08 PHASE2
NCT01034917 COMPLETED
HIV
Germans Trias i Pujol Hospital
 2009-12 PHASE3
NCT01427504 COMPLETED
Hepatitis C; HIV
University of Colorado, Denver
 2011-08
NCT01336829 COMPLETED
Hepatitis C; HIV
Tibotec Pharmaceuticals, Ireland
 2011-03 PHASE1
NCT01427504 Completed
Hepatitis C|HIV
University of Colorado Denver
 2011-08 Not Applicable
NCT01347658 COMPLETED
HIV
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
 2011-04
NCT01199731 TERMINATED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2010-10-05 PHASE2
NCT01876966 COMPLETED
HIV
Janssen Pharmaceutica N.V., Belgium
 2011-03 PHASE1
NCT00665847 COMPLETED
HIV-1
Tibotec Pharmaceuticals, Ireland
 2008-11 PHASE2
NCT01347658 Completed
HIV
Fundación FLS de Lucha Contra el Sida las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
 2011-04 Not Applicable
NCT01121809 COMPLETED
HIV-1 Infection; HIV Infections
Hospitales Universitarios Virgen del Rocío
 2010-04 PHASE4
NCT01090648 COMPLETED
HIV-Infections
Tibotec Pharmaceuticals, Ireland
 2010-03 PHASE1
NCT01625169 Completed
HIV
University of Southern California|Tibotec Therapeutics a Division of Ortho Biotech Products L.P. USA
 2010-04 Not Applicable
NCT00871234 COMPLETED
Endothelial Function; Lipids; Insulin Resistance; Inflammation; HIV Infections
Indiana University
 2009-04 PHASE1
NCT01090648 Completed
HIV-Infections
Tibotec Pharmaceuticals Ireland
 2010-03 Phase 1
NCT00782301 WITHDRAWN
Hepatitis B; Human Immunodeficiency Virus; Hepatitis C, Chronic
ViiV Healthcare
 2009-03 PHASE4
NCT00903682 COMPLETED
HIV Infection; HIV; Acquired Immunodeficiency Syndrome
Janssen-Cilag International NV
 2009-06 PHASE2
NCT00855088 COMPLETED
HIV/AIDS; HIV Infections
University of North Carolina, Chapel Hill
 2009-07 PHASE1
NCT00920296 COMPLETED
Healthy Subjects; Infection, Human Immunodeficiency Virus
GlaxoSmithKline
 2009-07 PHASE1
NCT00792324 COMPLETED
HIV
St Stephens Aids Trust
 2008-06 PHASE3
NCT00867152 COMPLETED
Healthy Volunteer
ViiV Healthcare
 2009-04 PHASE1
NCT00767117 COMPLETED
HIV
Tibotec Pharmaceuticals, Ireland
 2008-09 PHASE1
NCT00774111 COMPLETED
Healthy Subjects
GlaxoSmithKline
 2008-10 PHASE1
NCT00792584 COMPLETED
Sleep Disorders
University Hospital, Geneva
 2008-11
NCT00128830 COMPLETED
Human Immunodeficiency Virus Type 1
Tibotec Pharmaceuticals, Ireland
 2005-06 PHASE2
NCT00460382 COMPLETED
HIV Infections
French National Agency for Research on AIDS and Viral Hepatitis
 2007-05 PHASE2

(data from https://clinicaltrials.gov, updated on 2023-09-21)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Etravirine functions as a non-nucleoside reverse transcriptase inhibitor that directly binds to a hydrophobic pocket adjacent to the catalytic site of HIV-1 reverse transcriptase, inducing a conformational change that potently blocks viral DNA polymerase activity. By inhibiting the synthesis of proviral DNA within host immune cells, this agent prevents viral replication and integration, demonstrating therapeutic relevance in controlling viral load in patients with HIV-1 infection and AIDS.

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.