Clinical Trials

Cobicistat has been evaluated across numerous clinical trials spanning Early Phase 1 through Phase 4, focusing primarily on HIV-1 and AIDS management, drug-drug interactions, and adult acute myeloid leukemia. Sponsored by pharmaceutical entities—such as Gilead Sciences and Janssen—alongside academic cooperative organizations, these protocols encompass completed, actively recruiting, terminated, and withdrawn recruitment statuses. Evaluated interventions range from fixed-dose HIV-1 formulations to cobicistat-boosted combination regimens in acute myeloid leukemia.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06337032 RECRUITING
HIV-1-infection
Gilead Sciences
 2024-08-27 PHASE4
NCT06014489 RECRUITING
AML, Adult
Stichting Hemato-Oncologie voor Volwassenen Nederland
 2024-01-17 PHASE2
NCT04065399 RECRUITING
Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Mixed Lineage Acute Leukemia; Mixed Phenotype Acute Leukemia; Acute Leukemia of Ambiguous Lineage
Syndax Pharmaceuticals
 2019-11-05 PHASE1; PHASE2
NCT07462559 NOT_YET_RECRUITING
Drug Drug Interaction
Helsinki University Central Hospital
 2026-03-04 PHASE1
NCT07678268 RECRUITING
HIV Infection; Antiretroviral Therapy; Lentivirus Infections
Instituto Mexicano del Seguro Social
 2025-07-10 PHASE4
NCT05748093 UNKNOWN
Non-small Cell Lung Cancer
Maastricht University Medical Center
 2024-04-01 PHASE4
NCT06907056 RECRUITING
HIV Infection
José Antonio Mata Marín
 2023-11-09 PHASE4
NCT05078671 UNKNOWN
Cancer
Radboud University Medical Center
 2021-12-15 PHASE4
NCT06787976 UNKNOWN
HIV; Insomnia; Anxiety
Instituto Mexicano del Seguro Social
 2025-06-19 PHASE4
NCT02016924 ACTIVE_NOT_RECRUITING
Acquired Immune Deficiency Syndrome (AIDS); HIV Infections
Gilead Sciences
 2014-01-16 PHASE2; PHASE3
NCT06726382 COMPLETED
Drug Interactions; Food-drug Interaction
Helsinki University Central Hospital
 2024-12-09 PHASE1
NCT05463783 UNKNOWN
HIV Infections; Obesity
East Carolina University
 2023-03-14 PHASE4
NCT06385119 COMPLETED
Healthy Participants
Fore Biotherapeutics
 2024-04-24 PHASE1
NCT04388904 COMPLETED
HIV-1-infection
The Crofoot Research Center, Inc.
 2021-09-01 PHASE4
NCT05494866 TERMINATED
CYP3A Inhibitor; Advanced Stage or Metastatic Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer; Pancreatic Adenocarcinoma; Pancreatic Neoplasm
German Cancer Research Center
 2022-12-07 PHASE1
NCT06014489 Recruiting
AML Adult
Stichting Hemato-Oncologie voor Volwassenen Nederland
 2024-01-17 Phase 2
NCT04442737 COMPLETED
HIV-1
Janssen Scientific Affairs, LLC
 2020-07-01 PHASE4
NCT05716854 COMPLETED
Drug-induced QT Prolongation; Pharmacokinetics; Pharmacodynamics
Food and Drug Administration (FDA)
 2023-03-21 PHASE1
NCT05458102 TERMINATED
Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Gilead Sciences
 2022-08-19 PHASE1
NCT03864406 COMPLETED
Healthy Volunteers
National Institutes of Health Clinical Center (CC)
 2019-06-04 PHASE1
NCT05692570 COMPLETED
Drug-drug Interaction
Pyramid Biosciences
 2022-09-09 PHASE1
NCT05378906 COMPLETED
Healthy
Janssen Research & Development, LLC
 2022-06-07 PHASE1
NCT05197075 COMPLETED
Human Immunodeficiency Virus (HIV)
Janssen Research & Development, LLC
 2022-08-03 PHASE1
NCT05197075 Completed
Human Immunodeficiency Virus (HIV)
Janssen Research & Development LLC
 2022-08-03 Phase 1
NCT05236738 COMPLETED
Healthy Participants
Bristol-Myers Squibb
 2022-05-13 PHASE1
NCT04040075 TERMINATED
HIV-1-infection
Southampton Healthcare, Inc.
 2019-07-01 PHASE4
NCT05378906 Completed
Healthy
Janssen Research & Development LLC
 2022-06-07 Phase 1
NCT04709692 COMPLETED
Malaria, Falciparum; Malaria, Vivax
R. Kiplin Guy
 2021-04-14 PHASE2
NCT03717129 COMPLETED
Healthy Volunteers
Johns Hopkins University
 2019-04-15 PHASE4
NCT03858491 COMPLETED
Non Small Cell Lung Cancer
Academisch Ziekenhuis Maastricht
 2020-11-01 EARLY_PHASE1
NCT02307656 COMPLETED
HIV in Adults
Bristol-Myers Squibb
 2014-12-12 PHASE1
NCT02771249 COMPLETED
HIV Infected Population With Latent Tuberculosis
National Institutes of Health Clinical Center (CC)
 2016-06-03 PHASE1
NCT03683524 COMPLETED
HIV-1 Infection
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
 2018-11-19 PHASE4
NCT04661397 COMPLETED
Healthy
Janssen Research & Development, LLC
 2021-01-05 PHASE1
NCT04208061 COMPLETED
Healthy
Janssen Research & Development, LLC
 2019-12-18 PHASE1
NCT04718805 COMPLETED
Healthy
Janssen Research & Development, LLC
 2021-01-26 PHASE1
NCT03480646 COMPLETED
Metastatic Castration Resistant Prostate Cancer (mCRPC)
Constellation Pharmaceuticals
 2017-11-15 PHASE1; PHASE2
NCT02859558 COMPLETED
HIV-1 Infection
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
 2017-01-24 PHASE2
NCT04263350 COMPLETED
Healthy Participants
Bristol-Myers Squibb
 2020-02-26 PHASE1
NCT03447873 COMPLETED
HIV Infections
Hospitales Universitarios Virgen del Rocío
 2017-06-01 PHASE4
NCT04252274 UNKNOWN
Pneumonia, Pneumocystis; Coronavirus
Shanghai Public Health Clinical Center
 2020-01-30 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
NCT03163277 TERMINATED
Hiv; Neurocognitive Dysfunction
Giovanni Di Perri
 2017-05-15 PHASE4
NCT03685500 COMPLETED
HIV Infections
Fundacion SEIMC-GESIDA
 2018-12-04 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
NCT04236453 TERMINATED
Healthy
Janssen Pharmaceutica N.V., Belgium
 2020-01-23 PHASE1
NCT04322214 COMPLETED
Pharmacokinetic Interactions; HIV
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
 2020-01-30 PHASE1
NCT04006704 COMPLETED
HIV-1
Janssen Pharmaceutica N.V., Belgium
 2019-10-10 PHASE1
NCT02987530 COMPLETED
HIV-1 Infection
ANRS, Emerging Infectious Diseases
 2017-04-11 PHASE3
NCT04064632 UNKNOWN
HIV Infection
A.O. Ospedale Papa Giovanni XXIII
 2017-02-01 PHASE4
NCT03067285 COMPLETED
HIV Infections
Fundacion SEIMC-GESIDA
 2017-09-08 PHASE4
NCT03227861 COMPLETED
HIV-1
Janssen Scientific Affairs, LLC
 2017-07-31 PHASE3
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
NCT03045861 COMPLETED
Infection, Human Immunodeficiency Virus; HIV Infections
GlaxoSmithKline
 2017-03-17 PHASE2
NCT03493568 TERMINATED
HIV-1-infection
IRCCS San Raffaele
 2017-02-06 PHASE3
NCT02661373 COMPLETED
Malaria
St. Jude Children's Research Hospital
 2016-03-01 PHASE1
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
NCT02697851 TERMINATED
HIV
St Stephens Aids Trust
 2016-07 PHASE1
NCT02652624 COMPLETED
HIV-1 Infection
Gilead Sciences
 2016-02-19 PHASE3
NCT02707601 COMPLETED
HIV-1 Infection; HCV Infection
Gilead Sciences
 2016-04-01 PHASE3
NCT02735863 COMPLETED
HIV Infection
Abivax S.A.
 2016-05 PHASE2
NCT02470650 WITHDRAWN
Patient Compliance; Antiretroviral Therapy Intolerance
Juan A. Arnaiz
 2015-06 PHASE4
NCT02605954 COMPLETED
HIV-1 Infection
Gilead Sciences
 2015-11-18 PHASE3
NCT04069221 COMPLETED
Malaria
Medicines for Malaria Venture
 2017-02-28 PHASE1
NCT03123848 COMPLETED
Healthy
Janssen Pharmaceutical K.K.
 2017-04-14 PHASE4
NCT02431247 COMPLETED
Immunodeficiency Virus Type 1, Human
Janssen Sciences Ireland UC
 2015-07-06 PHASE3
NCT02199613 COMPLETED
HIV Infection
University of British Columbia
 2014-10 PHASE4
NCT02269917 COMPLETED
Human Immunodeficiency Virus Type 1
Janssen R&D Ireland
 2015-03 PHASE3
NCT02984852 COMPLETED
Healthy
Janssen Scientific Affairs, LLC
 2016-12 PHASE1
NCT01896622 COMPLETED
HIV
National Institutes of Health Clinical Center (CC)
 2013-06-18 PHASE1
NCT02503462 TERMINATED
AIDS-related Dementia Complex
University Hospital, Basel, Switzerland
 2015-07 PHASE4
NCT02180438 COMPLETED
HIV-2 Infection
University of Washington
 2014-09 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
NCT02404233 UNKNOWN
HIV Positive
Therapeutic Concepts
 2015-03 PHASE4
NCT00855335 COMPLETED
HIV; HIV Infections; Pregnancy
Janssen Scientific Affairs, LLC
 2009-04-09 PHASE3
NCT02198443 COMPLETED
HIV
Fundacion Clinic per a la Recerca Biomédica
 2015-06-06 PHASE4
NCT02499978 WITHDRAWN
HIV/AIDS
Stanford University
 2016-05 PHASE2; PHASE3
NCT01694420 COMPLETED
HIV
Duke University
 2012-09 PHASE3
NCT02351908 COMPLETED
HIV
St Stephens Aids Trust
 2015-03 PHASE4
NCT02625207 COMPLETED
Healthy Subjects
ViiV Healthcare
 2015-11-06 PHASE1
NCT02589158 COMPLETED
HIV
St Stephens Aids Trust
 2015-11 PHASE1
NCT02578550 COMPLETED
Healthy
Janssen Sciences Ireland UC
 2015-11 PHASE1
NCT02246998 COMPLETED
HIV-1 Infection
Gilead Sciences
 2014-12-15 PHASE4
NCT02565888 COMPLETED
Hepatitis C; HIV
Radboud University Medical Center
 2015-11 PHASE1
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
NCT02277600 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2014-11-05 PHASE1
NCT02219217 COMPLETED
HIV
St Stephens Aids Trust
 2014-10 PHASE1
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
NCT01495702 COMPLETED
Acquired Immunodeficiency Syndrome; HIV Infections
Gilead Sciences
 2011-12 PHASE3
NCT01475838 COMPLETED
Acquired Immunodeficiency Syndrome; HIV Infections
Gilead Sciences
 2011-11 PHASE3
NCT01837719 COMPLETED
Human Immunodeficiency Virus Type 1 (HIV-1)
Bristol-Myers Squibb
 2013-04 PHASE1
NCT01565850 COMPLETED
Acquired Immunodeficiency Syndrome; HIV Infections
Gilead Sciences
 2012-04 PHASE2
NCT01363011 COMPLETED
Acquired Immunodeficiency Syndrome; HIV Infections
Gilead Sciences
 2011-05 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
NCT01440569 COMPLETED
Acquired Immunodeficiency Syndrome; HIV Infections
Gilead Sciences
 2011-09 PHASE3
NCT01619527 COMPLETED
Healthy Participants
Janssen R&D Ireland
 2012-04 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-06-10)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cobicistat selectively binds to and inhibits cytochrome P450 3A enzymes, thereby blocking the oxidative hepatic clearance of co-administered therapeutic agents. By suppressing enzymatic degradation, it significantly enhances the systemic exposure and bioavailability of companion drugs, boosting the pharmacokinetic profiles of treatment regimens for conditions such as human immunodeficiency virus infection and acute myeloid leukemia.

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.