Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate elvitegravir, primarily investigating HIV-1 infection, HIV/AIDS, and safety in healthy volunteers to assess pharmacokinetic profiles and therapeutic efficacy. Featuring completed, terminated, and withdrawn recruitment statuses, these studies are sponsored by diverse entities, including pharmaceutical companies such as Gilead Sciences, research universities, and public health organizations like the National Institute of Allergy and Infectious Diseases and the Centers for Disease Control and Prevention.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06274398 COMPLETED
Safety Issues
Eastern Virginia Medical School
 2024-01-16 PHASE1
NCT06087913 COMPLETED
Safety Issues
Eastern Virginia Medical School
 2023-11-08 PHASE1
NCT04040075 TERMINATED
HIV-1-infection
Southampton Healthcare, Inc.
 2019-07-01 PHASE4
NCT03717129 COMPLETED
Healthy Volunteers
Johns Hopkins University
 2019-04-15 PHASE4
NCT04047420 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2019-12-11 PHASE1
NCT02859558 COMPLETED
HIV-1 Infection
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
 2017-01-24 PHASE2
NCT03549312 UNKNOWN
HIV-1-infection; Hepatitis C, Chronic; Methadone Dependence; Opioid Dependence; Bone Diseases, Metabolic; HIV/AIDS; Co-infection; Buprenorphine Dependence; HCV Coinfection
Saskatchewan Health Authority - Regina Area
 2018-02-01 PHASE4
NCT03693508 COMPLETED
HIV Infections; Severe Immunosuppression
Fundacion SEIMC-GESIDA
 2018-04-13 PHASE4
NCT01854775 COMPLETED
Acquired Immune Deficiency Syndrome (AIDS); HIV Infections
Gilead Sciences
 2013-05-06 PHASE2; PHASE3
NCT03405194 WITHDRAWN
HIV/AIDS
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
 2018-05-01
NCT04047420 Completed
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)|CONRAD
 2019-12-11 Phase 1
NCT03067285 COMPLETED
HIV Infections
Fundacion SEIMC-GESIDA
 2017-09-08 PHASE4
NCT03762772 COMPLETED
Hiv; HSV
CONRAD
 2018-12-10 PHASE1
NCT03976752 Completed
HIV/AIDS
Emory University|Centers for Disease Control and Prevention
 2019-03-13 Phase 1
NCT03405935 COMPLETED
HIV-1 Infection
Gilead Sciences
 2018-03-01 PHASE3
NCT02616029 COMPLETED
HIV-1 Infection
Gilead Sciences
 2015-12-17 PHASE3
NCT02998320 COMPLETED
HIV Risk
Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
 2017-03-10 PHASE3
NCT03493568 TERMINATED
HIV-1-infection
IRCCS San Raffaele
 2017-02-06 PHASE3
NCT02397096 COMPLETED
HIV-1 Infection
Merck Sharp & Dohme LLC
 2015-06-09 PHASE3
NCT02616783 COMPLETED
HIV-1 Infection
Gilead Sciences
 2015-12-22 PHASE3
NCT02660905 COMPLETED
Human Immunodeficiency Virus; Hepatitis C, Chronic
Ottawa Hospital Research Institute
 2016-04 PHASE3
NCT01923311 TERMINATED
Acquired Immune Deficiency Syndrome (AIDS); HIV Infections
Gilead Sciences
 2013-08-26 PHASE2; PHASE3
NCT02652624 COMPLETED
HIV-1 Infection
Gilead Sciences
 2016-02-19 PHASE3
NCT02707601 COMPLETED
HIV-1 Infection; HCV Infection
Gilead Sciences
 2016-04-01 PHASE3
NCT02470650 WITHDRAWN
Patient Compliance; Antiretroviral Therapy Intolerance
Juan A. Arnaiz
 2015-06 PHASE4
NCT02605954 COMPLETED
HIV-1 Infection
Gilead Sciences
 2015-11-18 PHASE3
NCT02199613 COMPLETED
HIV Infection
University of British Columbia
 2014-10 PHASE4
NCT02985996 Completed
HIV Infections
Emory University|Centers for Disease Control and Prevention
 2017-02-06 Phase 1
NCT02251236 COMPLETED
HIV
University of California, San Diego
 2016-01
NCT02180438 COMPLETED
HIV-2 Infection
University of Washington
 2014-09 PHASE4
NCT02198443 COMPLETED
HIV
Fundacion Clinic per a la Recerca Biomédica
 2015-06-06 PHASE4
NCT01694420 COMPLETED
HIV
Duke University
 2012-09 PHASE3
NCT02351908 COMPLETED
HIV
St Stephens Aids Trust
 2015-03 PHASE4
NCT02246998 COMPLETED
HIV-1 Infection
Gilead Sciences
 2014-12-15 PHASE4
NCT02251236 Completed
HIV
University of California San Diego|Gilead Sciences|University at Buffalo
 2016-01 Not Applicable
NCT02600819 Completed
HIV-1 Infection
Gilead Sciences
 2015-12-14 Phase 3
NCT01721109 COMPLETED
Acquired Immunodeficiency Syndrome; HIV Infections
Gilead Sciences
 2012-12-06 PHASE2; PHASE3
NCT01929759 COMPLETED
HIV Disease
Massachusetts General Hospital
 2014-01
NCT02475135 COMPLETED
Healthy
Janssen Sciences Ireland UC
 2015-06-01 PHASE1
NCT02220868 COMPLETED
Hepatitis C Infection; HIV Infection
Saint Michael's Medical Center
 2014-07 PHASE4
NCT01968551 COMPLETED
HIV-1; HIV Infections; Acquired Immunodeficiency Syndrome
Gilead Sciences
 2013-09-03 PHASE3
NCT01967940 COMPLETED
HIV; HIV Infections; Acquired Immunodeficiency Syndrome
Gilead Sciences
 2013-10-25 PHASE3
NCT01705574 COMPLETED
Acquired Immunodeficiency Syndrome; HIV Infections
Gilead Sciences
 2012-10-24 PHASE3
NCT02071082 COMPLETED
HIV; HBV
Gilead Sciences
 2014-02-25 PHASE3
NCT02219217 COMPLETED
HIV
St Stephens Aids Trust
 2014-10 PHASE1
NCT02295384 Completed
HIV
Holdsworth House Medical Practice|Gilead Sciences
 2014-11 --
NCT02203461 COMPLETED
Insulin Resistance
Technical University of Munich
 2014-07 PHASE1
NCT01797445 COMPLETED
HIV; HIV Infections
Gilead Sciences
 2013-03-12 PHASE3
NCT01780506 COMPLETED
HIV; HIV Infections
Gilead Sciences
 2012-12-26 PHASE3
NCT01818596 COMPLETED
HIV; HIV Infections
Gilead Sciences
 2013-03-27 PHASE3
NCT01855867 COMPLETED
Human Immunodeficiency Virus
Kenneth H. Mayer, MD
 2013-05 PHASE4
NCT01475838 COMPLETED
Acquired Immunodeficiency Syndrome; HIV Infections
Gilead Sciences
 2011-11 PHASE3
NCT01495702 COMPLETED
Acquired Immunodeficiency Syndrome; HIV Infections
Gilead Sciences
 2011-12 PHASE3
NCT01533259 COMPLETED
Acquired Immunodeficiency Syndrome; HIV Infections
Gilead Sciences
 2012-01 PHASE3
NCT01497899 COMPLETED
Acquired Immunodeficiency Syndrome; HIV Infections
Gilead Sciences
 2011-12-28 PHASE2
NCT01106586 COMPLETED
HIV; HIV Infections
Gilead Sciences
 2010-04 PHASE3
NCT01095796 COMPLETED
HIV; HIV Infections
Gilead Sciences
 2010-03 PHASE3
NCT00708162 COMPLETED
HIV Infection
Gilead Sciences
 2008-07 PHASE3
NCT00869557 COMPLETED
HIV; HIV Infections
Gilead Sciences
 2009-04 PHASE2

(data from https://clinicaltrials.gov, updated on 2025-07-25)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Elvitegravir selectively binds to and inhibits HIV integrase, thereby blocking the essential strand transfer step required for the integration of proviral DNA into the host cell genome. By preventing proviral DNA insertion, elvitegravir stops viral replication and halts retroviral spread, rendering it clinically effective for the treatment of HIV-1 infection and Acquired Immunodeficiency Syndrome.

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.