Clinical Trials

Cabotegravir (GSK1265744) has an extensive development history supported by numerous clinical trials spanning Phase 1 through Phase 4 studies in HIV-1 treatment and pre-exposure prophylaxis (PrEP), including specific cohorts such as breastfeeding women and individuals requiring contraception. Sponsored by pharmaceutical companies like ViiV Healthcare and Gilead Sciences alongside academic and governmental organizations like Georgetown University, these trials encompass completed, recruiting, and active but not recruiting protocols. These studies range from early-phase safety and pharmacokinetic evaluations of long-acting formulations to Phase 4 PrEP efficacy research in high-risk populations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07672717 RECRUITING
HIV; Prophylaxis; Injectable
Johns Hopkins University
 2026-07-07 PHASE1
NCT06854029 NOT_YET_RECRUITING
HIV Infections; Opioid Use Disorder; Incarceration; Lens
Duke University
 2026-09-01 PHASE4
NCT07275606 RECRUITING
HIV Infections
ViiV Healthcare
 2026-04-15 PHASE1; PHASE2
NCT07650916 RECRUITING
HIV Infections
ViiV Healthcare
 2026-06-25 PHASE3
NCT07682961 RECRUITING
HIV Infections
Gilead Sciences
 2026-07-14 PHASE3
NCT07346508 NOT_YET_RECRUITING
HIV (Human Immunodeficiency Virus)
KC Care Health Center
 2026-04-01
NCT07199335 RECRUITING
HIV; Substance Use Disorder (SUD); Injection Drug Use
Massachusetts General Hospital
 2026-02-24 PHASE4
NCT06474364 RECRUITING
HIV
MU-JHU CARE
 2024-08-05 PHASE4
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NCT06336434 WITHDRAWN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
NCT05986084 ACTIVE_NOT_RECRUITING
Pre-Exposure Prophylaxis (PrEP); Breast Feeding
Beth Israel Deaconess Medical Center
 2023-11-30 PHASE4
NCT05418868 RECRUITING
HIV Infections
ViiV Healthcare
 2022-06-14 PHASE1
NCT05044962 RECRUITING
HIV Infections; Contraception; Drug-drug Interaction
University of Alabama at Birmingham
 2021-11-26
NCT06786520 ACTIVE_NOT_RECRUITING
HIV Infections
ViiV Healthcare
 2025-01-17 PHASE1
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
NCT06741397 ACTIVE_NOT_RECRUITING
HIV Infections
ViiV Healthcare
 2024-12-20 PHASE2
NCT06834113 RECRUITING
HIV I Infection; Injection Pain
Centre Hospitalier Régional d'Orléans
 2025-01-24
NCT06657885 WITHDRAWN
HIV1 Infection; Multi-treated Patients Who Have Received Multiple Lines of Antiretroviral Treatment; CABOTEGRAVIR; LENACAPAVIR; Stable Oral Antiretroviral Treatment for at Least 6 Months
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
 2025-01-15 PHASE2
NCT06485154 RECRUITING
HIV Prevention
University of Witwatersrand, South Africa
 2024-06-01 PHASE4
NCT05996471 ACTIVE_NOT_RECRUITING
HIV Infections
ViiV Healthcare
 2023-08-17 PHASE2
NCT06250504 RECRUITING
HIV Infections
Africa Health Research Institute
 2024-02-27 PHASE3
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
NCT06133686 NOT_YET_RECRUITING
HIV
MRC/UVRI and LSHTM Uganda Research Unit
 2024-04-01 PHASE3
NCT06138600 UNKNOWN
HIV Infections
University of Witwatersrand, South Africa
 2023-11-01 PHASE3
NCT06273943 NOT_YET_RECRUITING
Prevention
ANRS, Emerging Infectious Diseases
 2024-04-01 PHASE3
NCT05515770 RECRUITING
HIV Infections
Evandro Chagas National Institute of Infectious Disease
 2022-09-20 PHASE3
NCT05917509 COMPLETED
HIV Infections
ViiV Healthcare
 2023-07-06 PHASE3
NCT05514509 COMPLETED
HIV Infections
ViiV Healthcare
 2022-10-28 PHASE4
NCT06033547 COMPLETED
HIV Infections
ViiV Healthcare
 2023-09-12 PHASE1
NCT06970223 ACTIVE_NOT_RECRUITING
HIV Infections
ViiV Healthcare
 2025-04-22 PHASE1
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
NCT06643897 COMPLETED
HIV-1-infection
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
 2024-07-16
NCT05374525 COMPLETED
HIV Infections
ViiV Healthcare
 2022-05-18 PHASE4
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
NCT03739996 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2019-12-31 PHASE2
NCT06319105 Recruiting
Oral Pre-exposure Prophylaxis (PrEP)|Long-acting Injectable Cabotegravir for PrEP
Georgetown University|AIDS Vaccine Advocacy Coalition|Centers for Disease Control and Prevention|Center for the Development of People|Cooper/Smith|Elizabeth Glaser Pediatric AIDS Foundation|Family Health Services|Healthqual|Johns Hopkins Research Project Malawi|Johns Hopkins Bloomberg School of Public Health|Kamuzu University of Health Sciences|Blantyre District Health Office Malawi|Lilongwe District Health Office Malawi|Lighthouse Trust|Ministry of Health Malawi|National AIDS Commission Malawi|Pakachere Institute of Health and Development Communication|Partners in Hope|Population Services International|University of North Carolina|United States Agency for International Development (USAID)|United States President''s Emergency Plan for AIDS Relief|Quantitative Engineering Design|Clinton Health Access Initiative-Malawi
 2024-03-26 --
NCT05096949 TERMINATED
HIV-1-infection; Medication Adherence; Satisfaction, Patient
University of Arkansas
 2022-03-07
NCT05549726 COMPLETED
HIV
University of California, San Francisco
 2023-01-02 PHASE4
NCT06104306 Recruiting
HIV-1-infection
Gilead Sciences
 2023-12-13 Phase 4
NCT05986084 Recruiting
Pre-Exposure Prophylaxis (PrEP)|Breast Feeding
Beth Israel Deaconess Medical Center|Botswana Harvard AIDS Institute Partnership|Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|ViiV Healthcare
 2023-11-30 Phase 4
NCT05896748 COMPLETED
Human Immunodeficiency Virus Type 1 (HIV-1)
ViiV Healthcare
 2022-11-08 PHASE3
NCT04692077 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2020-02-19 PHASE2
NCT05776108 COMPLETED
HIV Infections
ViiV Healthcare
 2023-03-23 PHASE1
NCT04484337 COMPLETED
HIV Infections
ViiV Healthcare
 2020-07-31 PHASE1
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
NCT04824131 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2020-11-04 PHASE2
NCT05896761 COMPLETED
Human Immunodeficiency Virus Type 1 (HIV-1)
ViiV Healthcare
 2021-10-28 PHASE3
NCT04542070 COMPLETED
HIV Infections
ViiV Healthcare
 2020-11-09 PHASE3
NCT04399551 COMPLETED
HIV Infections
ViiV Healthcare
 2020-09-28 PHASE3
NCT04371380 COMPLETED
HIV Infections
ViiV Healthcare
 2020-09-16 PHASE1
NCT03164564 ACTIVE_NOT_RECRUITING
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2017-11-07 PHASE3
NCT04001803 COMPLETED
HIV Infections
ViiV Healthcare
 2019-07-08 PHASE3
NCT02720094 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2016-12-19 PHASE2; PHASE3
NCT03422172 COMPLETED
HIV Infections
ViiV Healthcare
 2018-04-10 PHASE1
NCT03639311 COMPLETED
HIV Infections
ViiV Healthcare
 2018-09-24 PHASE2
NCT02478463 COMPLETED
Infection, Human Immunodeficiency Virus; HIV Infections
ViiV Healthcare
 2017-02-27 PHASE1
NCT03299049 ACTIVE_NOT_RECRUITING
HIV Infections
ViiV Healthcare
 2017-10-27 PHASE3
NCT02462772 WITHDRAWN
Human Immunodeficiency Virus
Centre for the AIDS Programme of Research in South Africa
 2015-10 PHASE2
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
NCT03149848 COMPLETED
Infection, Human Immunodeficiency Virus; HIV Infections
ViiV Healthcare
 2017-06-06 PHASE1
NCT02178800 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2015-02 PHASE2
NCT02354937 COMPLETED
Infection, Human Immunodeficiency Virus; HIV Infections
ViiV Healthcare
 2015-07-13 PHASE1
NCT02354950 COMPLETED
HIV Infections
ViiV Healthcare
 2015-06-22 PHASE1
NCT02799264 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2016-06 PHASE1
NCT02411435 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2015-07 PHASE1
NCT02120352 COMPLETED
Infection, Human Immunodeficiency Virus; HIV Infections
ViiV Healthcare
 2014-04-28 PHASE2
NCT02345707 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2015-03 PHASE1
NCT02076178 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2014-03-27 PHASE2
NCT02159131 COMPLETED
Infections, Human Immunodeficiency Virus and Hepatitis
ViiV Healthcare
 2014-08 PHASE1
NCT02059031 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2014-02 PHASE1
NCT02027454 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2014-01 PHASE1
NCT01754116 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2013-01 PHASE1
NCT01593046 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2012-05 PHASE1
NCT01641809 COMPLETED
Infection, Human Immunodeficiency Virus; HIV Infections
ViiV Healthcare
 2012-08-06 PHASE2
NCT01848340 COMPLETED
HIV-associated Lipodystrophy Syndrome
ViiV Healthcare
 2013-05 PHASE1
NCT01756131 COMPLETED
Infections, Human Immunodeficiency Virus and Herpesviridae
ViiV Healthcare
 2010-09 PHASE1
NCT01648257 COMPLETED
Infections, Human Immunodeficiency Virus and Hepatitis
ViiV Healthcare
 2012-08 PHASE1
NCT01467531 COMPLETED
Infections, Human Immunodeficiency Virus and Hepatitis
ViiV Healthcare
 2011-11 PHASE1
NCT00920296 COMPLETED
Healthy Subjects; Infection, Human Immunodeficiency Virus
GlaxoSmithKline
 2009-07 PHASE1
NCT00920426 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2009-06-09 PHASE2
NCT00659191 COMPLETED
HIV Infection
GlaxoSmithKline
 2008-02 PHASE1
NCT00812318 COMPLETED
HIV Infection; Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2008-06 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-07-13)

Check the GSK1265744 (Cabotegravir) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cabotegravir selectively binds to HIV-1 integrase and potently inhibits the catalyzed strand transfer reaction, thereby blocking the integration of retroviral DNA into the host chromosome and halting viral replication. This inhibition prevents the establishment and propagation of viral infection, providing the biological rationale for its therapeutic application in pre-exposure prophylaxis (PrEP) and 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.