Clinical Trials

Numerous clinical trials and observational protocols evaluate the therapeutic profile of bictegravir across Phase 1 through Phase 4 studies, focusing on HIV-1, acute HIV infection, and co-infections such as HIV/HBV and HCV. Supported by major pharmaceutical sponsors including Gilead Sciences and Merck Sharp & Dohme as well as academic institutions like the University of Southern California, research covers key areas such as post-switch regimen safety and pediatric combination therapies. Across these protocols, participant recruitment statuses vary widely, encompassing recruiting, active not recruiting, completed, and terminated trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07708727 RECRUITING
HIV-1-infection
Gilead Sciences
 2026-07-29 PHASE2; PHASE3
NCT06532656 ACTIVE_NOT_RECRUITING
HIV-1-infection
Gilead Sciences
 2024-11-20 PHASE2; PHASE3
NCT07266831 RECRUITING
Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Merck Sharp & Dohme LLC
 2025-12-18 PHASE2; PHASE3
NCT07055451 ACTIVE_NOT_RECRUITING
HIV-1-infection
Gilead Sciences
 2025-08-12 PHASE1
NCT06544733 ACTIVE_NOT_RECRUITING
HIV-1-Infection
Gilead Sciences
 2024-08-20 PHASE2; PHASE3
NCT06891066 ACTIVE_NOT_RECRUITING
Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Merck Sharp & Dohme LLC
 2025-04-14 PHASE2
NCT07645287 RECRUITING
HIV-1-infection
Gilead Sciences
 2026-06-15 PHASE2
NCT07476339 RECRUITING
HIV -1 Infection; HIV (Human Immunodeficiency Virus); HIV; HIV 1 Infection
CAN Community Health
 2026-06-17 PHASE4
NCT07031063 RECRUITING
HIV Infection; Metabolic Syndrome; Antiretroviral Treatment
Instituto Mexicano del Seguro Social
 2025-04-01 PHASE4
NCT06374758 ACTIVE_NOT_RECRUITING
HIV Infections; ART; Noncompliance, Patient
University of Missouri-Columbia
 2024-04-29 PHASE4
NCT07532304 COMPLETED
Healthy
Merck Sharp & Dohme LLC
 2026-05-11 PHASE1
NCT07075146 RECRUITING
HIV - Human Immunodeficiency Virus; Obesity; Overweight and/or Obesity
José Antonio Mata Marín
 2025-05-05 PHASE3
NCT06630286 ACTIVE_NOT_RECRUITING
HIV-1-infection
Gilead Sciences
 2024-10-09 PHASE3
NCT05979311 ACTIVE_NOT_RECRUITING
HIV; HIV Infections
ViiV Healthcare
 2024-02-21 PHASE3
NCT06613685 TERMINATED
HIV-1-infection
Gilead Sciences
 2024-10-21 PHASE2; PHASE3
NCT05911360 COMPLETED
HIV; HIV Infections
ViiV Healthcare
 2023-07-07 PHASE3
NCT06333808 ACTIVE_NOT_RECRUITING
HIV-1-infection
Gilead Sciences
 2024-03-25 PHASE3
NCT05502341 ACTIVE_NOT_RECRUITING
HIV-1-infection
Gilead Sciences
 2022-08-16 PHASE2; PHASE3
NCT05463783 UNKNOWN
HIV Infections; Obesity
East Carolina University
 2023-03-14 PHASE4
NCT04564547 COMPLETED
HIV-1 Infection
Merck Sharp & Dohme LLC
 2021-03-09 PHASE2
NCT05289986 TERMINATED
Hiv
Chelsea and Westminster NHS Foundation Trust
 2023-11-21 PHASE4
NCT05663892 ACTIVE_NOT_RECRUITING
Hiv; Transgenderism
Maple Leaf Research
 2022-11-23 PHASE4
NCT05630755 ACTIVE_NOT_RECRUITING
HIV-1 Infection
Merck Sharp & Dohme LLC
 2023-02-17 PHASE3
NCT04530630 COMPLETED
HIV Infections; Renal Transplant Rejection
Weill Medical College of Cornell University
 2020-11-09 PHASE4
NCT06356194 COMPLETED
Healthy Volunteer Study
Atea Pharmaceuticals, Inc.
 2024-04-15 PHASE1
NCT05602506 COMPLETED
HIV Infections
Fundacion Clinic per a la Recerca Biomédica
 2022-11-15 PHASE4
NCT05122754 UNKNOWN
HIV-1-infection
Shanghai Public Health Clinical Center
 2021-12-08 PHASE4
NCT06629480 COMPLETED
Antiretroviral Treatment; HIV Infection; Metabolic Cardiovascular Syndrome
Instituto Mexicano del Seguro Social
 2021-06-25
NCT04884139 COMPLETED
HIV-1-infection
Fundacion SEIMC-GESIDA
 2021-07-14 PHASE4
NCT04734652 COMPLETED
HIV/AIDS; Tuberculosis, Pulmonary
Centre for the AIDS Programme of Research in South Africa
 2022-02-18 PHASE2
NCT05405751 COMPLETED
HIV Infections
Fundacion SEIMC-GESIDA
 2022-07-04 PHASE4
NCT06104306 Recruiting
HIV-1-infection
Gilead Sciences
 2023-12-13 Phase 4
NCT06177574 COMPLETED
HIV Infections
Carmen Hidalgo Tenorio
 2020-10-27 PHASE4
NCT06773754 ACTIVE_NOT_RECRUITING
Virally Suppressed People With HIV
National Taiwan University Hospital
 2022-06-14
NCT04585737 COMPLETED
HIV I Infection
Charlotte-Paige Rolle, MD
 2020-10-05 PHASE4
NCT04249037 TERMINATED
HIV/AIDS
University of Colorado, Denver
 2020-12-15 PHASE4
NCT03711253 UNKNOWN
Acute HIV Infection
University of Southern California
 2019-10-14 PHASE4
NCT05243602 COMPLETED
HIV-1-infection
University of Nairobi
 2022-02-01 PHASE4
NCT04712058 UNKNOWN
HIV Infections
National Taiwan University Hospital
 2021-01-20
NCT03797014 COMPLETED
HIV-1-infection; Hepatitis B
University of Maryland, Baltimore
 2019-04-30 PHASE4
NCT05602506 Active not recruiting
HIV Infections
Fundacion Clinic per a la Recerca Biomédica
 2022-11-15 Phase 4
NCT04483674 UNKNOWN
HIV Primary Infection
Anna Cruceta
 2020-12-04 PHASE2
NCT04542070 COMPLETED
HIV Infections
ViiV Healthcare
 2020-11-09 PHASE3
NCT04040075 TERMINATED
HIV-1-infection
Southampton Healthcare, Inc.
 2019-07-01 PHASE4
NCT04311957 UNKNOWN
HIV-1-infection; Antiretroviral Therapy
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
 2020-09-01 PHASE4
NCT03547908 COMPLETED
HIV-1/HBV Co-Infection
Gilead Sciences
 2018-05-30 PHASE3
NCT05222945 Unknown status
HIV-1-infection
ANRS Emerging Infectious Diseases|Gilead Sciences
 2022-02-01 Not Applicable
NCT04222283 UNKNOWN
HIV Infections
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
 2020-08-17 PHASE4
NCT04538040 COMPLETED
HIV-1-infection
Quest Clinical Research
 2019-12-19 PHASE4
NCT03998176 COMPLETED
HIV-1-infection
University of Nebraska
 2019-10-09 PHASE4
NCT04551573 WITHDRAWN
Tuberculosis; Hiv
Yale University
 2021-05 PHASE4
NCT04223791 COMPLETED
HIV Infection
Merck Sharp & Dohme LLC
 2020-02-18 PHASE3
NCT04853524 WITHDRAWN
Healthy
Janssen Research & Development, LLC
 2021-05-06 PHASE1
NCT03858478 UNKNOWN
HIV Seropositivity
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
 2019-11-18 PHASE4
NCT03986697 WITHDRAWN
Coronary Artery Disease; Hiv
University of Liverpool
 2020-02-04 PHASE4
NCT05606055 COMPLETED
HIV-1-infection
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
 2020-12-01 PHASE4
NCT03348163 TERMINATED
HIV Infections
The University of Texas Health Science Center, Houston
 2018-06-06 PHASE4
NCT02859558 COMPLETED
HIV-1 Infection
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
 2017-01-24 PHASE2
NCT03532425 TERMINATED
HIV-1-infection
University of Alberta
 2018-10-29 PHASE4
NCT04155554 UNKNOWN
HIV-1-infection
Azienda Ospedaliera Universitaria Senese
 2020-01-29 PHASE3
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
NCT04132674 UNKNOWN
Human Immunodeficiency Virus I Infection; Drug Use
Vancouver Infectious Diseases Centre
 2018-11-26 PHASE4
NCT03499483 COMPLETED
HIV Prevention
Fenway Community Health
 2019-01-24 PHASE4
NCT04054089 COMPLETED
HIV Infections
Cristina Mussini
 2020-01-23 PHASE4
NCT03502005 COMPLETED
Human Immunodeficiency Virus
Midland Research Group, Inc.
 2018-03-01 PHASE4
NCT03631732 COMPLETED
HIV-1 Infection
Gilead Sciences
 2018-08-28 PHASE3
NCT03110380 COMPLETED
HIV-1-infection
Gilead Sciences
 2017-06-12 PHASE3
NCT03405935 COMPLETED
HIV-1 Infection
Gilead Sciences
 2018-03-01 PHASE3
NCT02400307 COMPLETED
HIV
Gilead Sciences
 2015-04-17 PHASE1
NCT02275065 COMPLETED
HIV-1 Infection
Gilead Sciences
 2014-10-24 PHASE1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bictegravir selectively binds to the active site of HIV-1 integrase, thereby preventing the strand transfer step of viral DNA integration into the host cellular genome. By halting viral genomic insertion, the compound blocks viral replication cycles within host cells, which directly suppresses viral load in patients with 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.