Clinical Trials

Atazanavir has been evaluated in numerous Phase 1 through 4 clinical trials, encompassing completed, active, and terminated studies. Primarily targeting HIV-1 and AIDS alongside secondary conditions such as Hepatitis C, endotoxemia, sepsis, and HIV-associated lipodystrophy syndrome, these trials are sponsored by pharmaceutical companies like Bristol-Myers Squibb and academic partners such as the University of Liverpool and Radboud University Medical Center. Research across these studies focuses on assessing antiretroviral efficacy, pharmacokinetic profiles, dosage optimization, and metabolic safety.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02016924 ACTIVE_NOT_RECRUITING
Acquired Immune Deficiency Syndrome (AIDS); HIV Infections
Gilead Sciences
2014-01-16 PHASE2; PHASE3
NCT04022967 UNKNOWN
HIV-1-infection
ANRS, Emerging Infectious Diseases
2020-09-21 PHASE3
NCT04452565 UNKNOWN
Coronavirus Infection; Severe Acute Respiratory Infection; Severe Acute Respiratory Syndrome Coronavirus 2
Biomed Industries, Inc.
2022-06-15 PHASE2; PHASE3
NCT05680792 COMPLETED
Drug Interaction
Obafemi Awolowo University
2020-09-10
NCT04184869 COMPLETED
Solid Tumor; Hematological Malignancies
Acrotech Biopharma Inc.
2019-08-05 PHASE1
NCT05236738 COMPLETED
Healthy Participants
Bristol-Myers Squibb
2022-05-13 PHASE1
NCT04121195 COMPLETED
HIV/AIDS; Tuberculosis
University of Liverpool
2020-10-30 PHASE2; PHASE3
NCT02307656 COMPLETED
HIV in Adults
Bristol-Myers Squibb
2014-12-12 PHASE1
NCT04468087 COMPLETED
COVID-19
Hospital do Coracao
2021-02-15 PHASE2; PHASE3
NCT04385719 COMPLETED
Ebola; HIV/AIDS
Makerere University
2021-05-05 PHASE2
NCT04459286 TERMINATED
Covid-19
Obafemi Awolowo University
2020-10-09 PHASE2
NCT04263350 COMPLETED
Healthy Participants
Bristol-Myers Squibb
2020-02-26 PHASE1
NCT04121195 Active not recruiting
HIV/AIDS|Tuberculosis
University of Liverpool|European and Developing Countries Clinical Trials Partnership (Funder)|Joint Clinical Research Centre Kampala Uganda|University of Cape Town Cape Town South Africa|Infectious Diseases Institute Makerere University College of Health Sciences Kampala Uganda|University of Turin Turin Italy
2020-10-30 Phase 2|Phase 3
NCT04531072 COMPLETED
Drug Interaction
Fogarty International Center of the National Institute of Health
2018-09-18 PHASE4
NCT02652793 COMPLETED
Human Immunodeficiency Virus
Judit Pich
2015-11
NCT03708861 WITHDRAWN
HIV Infection
University of Turin, Italy
2016-01 PHASE3
NCT02473328 COMPLETED
HIV-1 Infection
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
2015-06 PHASE2
NCT02697851 TERMINATED
HIV
St Stephens Aids Trust
2016-07 PHASE1
NCT02652624 COMPLETED
HIV-1 Infection
Gilead Sciences
2016-02-19 PHASE3
NCT01829802 UNKNOWN
Chronic Infection With HIV
Pedro Cahn
2014-05 PHASE4
NCT02116660 TERMINATED
HIV Infections
Merck Sharp & Dohme LLC
2014-09-03 PHASE2
NCT02386098 TERMINATED
HIV Infections
ViiV Healthcare
2015-07-08 PHASE2
NCT02603107 COMPLETED
HIV-1 Infection
Gilead Sciences
2015-11-20 PHASE3
NCT02566707 TERMINATED
HIV-1 Infection
Radboud University Medical Center
2015-08 PHASE2
NCT01902186 TERMINATED
HIV Infection; Osteopenia
Giovanni Di Perri
2014-09 PHASE4
NCT02697851 Terminated
HIV
St Stephens Aids Trust|Bristol-Myers Squibb
2016-07 Phase 1
NCT02542852 COMPLETED
HIV-1 Infection
Castagna Antonella
2015-09 PHASE2
NCT01599364 COMPLETED
Human Immunodeficiency Virus
Catholic University of the Sacred Heart
2014-04 PHASE4
NCT02589158 COMPLETED
HIV
St Stephens Aids Trust
2015-11 PHASE1
NCT01003990 COMPLETED
HIV
Bristol-Myers Squibb
2002-10 PHASE3
NCT02246998 COMPLETED
HIV-1 Infection
Gilead Sciences
2014-12-15 PHASE4
NCT02565888 COMPLETED
Hepatitis C; HIV
Radboud University Medical Center
2015-11 PHASE1
NCT02154360 COMPLETED
HIV Infection
University of Pennsylvania
2014-05 PHASE1
NCT01367236 COMPLETED
HIV; Impaired Cognition
Imperial College London
2013-01 PHASE4
NCT01910402 COMPLETED
Infection, Human Immunodeficiency Virus; HIV Infections
ViiV Healthcare
2013-08-22 PHASE3
NCT03019783 COMPLETED
HIV
Brigham and Women's Hospital
2011-12 PHASE2; PHASE3
NCT01967940 COMPLETED
HIV; HIV Infections; Acquired Immunodeficiency Syndrome
Gilead Sciences
2013-10-25 PHASE3
NCT00074581 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
2005-02 PHASE3
NCT01705574 COMPLETED
Acquired Immunodeficiency Syndrome; HIV Infections
Gilead Sciences
2012-10-24 PHASE3
NCT01351740 COMPLETED
HIV Infection
University of British Columbia
2011-07 PHASE4
NCT02442700 COMPLETED
HIV; Dyslipidemia
Ramathibodi Hospital
2014-05 PHASE4
NCT01159223 COMPLETED
HIV Infections
The HIV Netherlands Australia Thailand Research Collaboration
2011-05 PHASE4
NCT01803074 COMPLETED
Infection, Human Immunodeficiency Virus; HIV Infections
ViiV Healthcare
2013-04-04 PHASE2
NCT02034838 COMPLETED
HIV Infection
Ottawa Hospital Research Institute
2014-01 PHASE1
NCT01691794 COMPLETED
HIV, Pediatric
Bristol-Myers Squibb
2012-11-30 PHASE4
NCT01335698 COMPLETED
HIV
Bristol-Myers Squibb
2011-05-27 PHASE3
NCT01605084 WITHDRAWN
HIV
Bristol-Myers Squibb
2012-06-30 PHASE3
NCT01307488 COMPLETED
HIV Infection
Fundacion SEIMC-GESIDA
2011-09 PHASE4
NCT02102048 UNKNOWN
HIV
University of Roma La Sapienza
2009-01
NCT01479361 COMPLETED
HIV; PCP; Toxoplasmosis
National Institutes of Health Clinical Center (CC)
2011-10-31 PHASE1
NCT01421355 COMPLETED
Type 1 Diabetes Mellitus
Brigham and Women's Hospital
2012-05 PHASE1
NCT01759875 COMPLETED
Healthy
University of California, San Francisco
2013-01 PHASE1
NCT00940771 COMPLETED
Pediatric HIV; HIV Infections
Phoenix Children's Hospital
2009-08-26 PHASE4
NCT01332227 COMPLETED
HIV, Combination Therapy
Bristol-Myers Squibb
2011-10 PHASE4
NCT01565889 COMPLETED
Hepatitis C; HIV
Gilead Sciences
2012-03 PHASE1; PHASE2
NCT01511809 COMPLETED
HIV-1 Infection
IRCCS San Raffaele
2010-09 PHASE3
NCT00491556 COMPLETED
HIV Infections
University of North Carolina, Chapel Hill
2007-10
NCT01837719 COMPLETED
Human Immunodeficiency Virus Type 1 (HIV-1)
Bristol-Myers Squibb
2013-04 PHASE1
NCT00811954 COMPLETED
HIV Infection
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
2009-05 PHASE3
NCT01274780 COMPLETED
HIV-1
Juan A. Arnaiz
2011-05 PHASE4
NCT00814879 COMPLETED
Acquired Immune Deficiency Syndrome; AIDS; Human Immunodeficiency Virus; HIV Infections
Yale University
2009-05
NCT01255371 WITHDRAWN
HIV
ANRS, Emerging Infectious Diseases
2012-03 PHASE3
NCT01818856 COMPLETED
Hepatitis C, Chronic; HIV Infection
Hospitales Universitarios Virgen del Rocío
2012-12 PHASE1
NCT00878306 COMPLETED
HIV Infections; Drug Abuse
University of California, San Francisco
2008-11 PHASE1
NCT01384734 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
2011-07-26 PHASE2
NCT01656109 COMPLETED
HIV
The HIV Netherlands Australia Thailand Research Collaboration
2011-07 PHASE2
NCT01620944 TERMINATED
HIV
Bristol-Myers Squibb
2012-07-31 PHASE3
NCT01105611 UNKNOWN
HIV Infections; Hepatitis C
St. James's Hospital, Ireland
2010-08 PHASE4
NCT00540137 COMPLETED
HIV Infections
Imperial College London
2007-07 PHASE4
NCT00762892 COMPLETED
HIV Infections
The University of Texas Health Science Center, Houston
2009-01 PHASE4
NCT00532168 COMPLETED
HIV Infections
Juan A. Arnaiz
2007-09 PHASE4
NCT01099579 COMPLETED
HIV Infections
Bristol-Myers Squibb
2010-10-13 PHASE3
NCT01225705 WITHDRAWN
HIV; Hepatitis C
University Hospital, Bonn
2010-10 PHASE4
NCT01102972 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
2010-04 PHASE4
NCT01592305 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
2012-05 PHASE1
NCT01602822 TERMINATED
HIV
Kenneth H. Mayer, MD
2012-02 PHASE4
NCT02404259 COMPLETED
HIV
The HIV Netherlands Australia Thailand Research Collaboration
2010-06
NCT00896051 COMPLETED
HIV Infections; Acquired Immunodeficiency Syndrome
Janssen R&D Ireland
2009-08 PHASE2
NCT01475227 COMPLETED
HIV Infection
St Stephens Aids Trust
2011-12 PHASE4
NCT00931801 COMPLETED
HIV
Community Research Initiative of New England
2009-12 PHASE4
NCT00544128 COMPLETED
HIV Infections
International Medical Center of Japan
2007-10 PHASE4
NCT01194856 TERMINATED
HIV Infection; Mitochondrial Dysfunction
The Cleveland Clinic
2010-10 PHASE4
NCT01108510 COMPLETED
HIV; HIV Infections
Gilead Sciences
2010-04 PHASE3
NCT01591850 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
2011-09 PHASE1
NCT00006604 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
2000-11 PHASE1; PHASE2
NCT01106586 COMPLETED
HIV; HIV Infections
Gilead Sciences
2010-04 PHASE3
NCT01404572 COMPLETED
HIV
Bristol-Myers Squibb
2011-08 PHASE1
NCT00874523 COMPLETED
HIV Infection
Kirby Institute
2009-07 PHASE3
NCT01232127 COMPLETED
HIV
Bristol-Myers Squibb
2011-02 PHASE4
NCT00756730 COMPLETED
HIV Infections
Community Research Initiative of New England
2008-09 PHASE4
NCT01458769 COMPLETED
Healthy Volunteers
Concert Pharmaceuticals
2010-12 PHASE1
NCT01928407 COMPLETED
HIV-1 Infection; Immunosuppression-related Infectious Disease
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
2011-02-23 PHASE4
NCT00335322 COMPLETED
Human Immunodeficiency Virus (HIV)
Kirby Institute
2007-02 PHASE4
NCT00389207 COMPLETED
HIV Infections
Boehringer Ingelheim
2006-10 PHASE3
NCT00869960 COMPLETED
Healthy
University of Alabama at Birmingham
2009-03 PHASE4
NCT00525239 UNKNOWN
HIV Infections
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
2004-03
NCT00943540 COMPLETED
HIV Infection; HIV Infections
Radboud University Medical Center
2009-07 PHASE2
NCT00827112 COMPLETED
Human Immunodeficiency Virus-1
ViiV Healthcare
2009-03 PHASE2
NCT00440947 COMPLETED
Infection, Human Immunodeficiency Virus I; HIV Infection
ViiV Healthcare
2007-03 PHASE3
NCT00833482 COMPLETED
Human Immunodeficiency Virus Type 1 (HIV-1); HIV Infections
Bristol-Myers Squibb
2009-09 PHASE1
NCT01073761 COMPLETED
HIV; HIV Infections
St Stephens Aids Trust
2010-04 PHASE1
NCT00885482 COMPLETED
HIV Infections
Catholic University of the Sacred Heart
2009-05 PHASE4
NCT00084136 COMPLETED
HIV Infections
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
2005-05 PHASE4
NCT00916448 COMPLETED
Endotoxemia; Inflammation; Multi Organ Dysfunction Syndrome; Sepsis
Radboud University Medical Center
2009-05
NCT00552240 COMPLETED
HIV Infections
Boehringer Ingelheim
2007-09 PHASE4
NCT00242216 COMPLETED
HIV Infections
The University of Texas Health Science Center, Houston
2004-05 PHASE4
NCT00768989 TERMINATED
HIV
Bristol-Myers Squibb
2008-11 PHASE2
NCT00307502 COMPLETED
HIV Infections
Germans Trias i Pujol Hospital
2005-01 PHASE1
NCT01445223 COMPLETED
HIV
Göteborg University
2004-04 PHASE4
NCT00892437 COMPLETED
HIV-1 Infection
Gilead Sciences
2009-05 PHASE2
NCT00118898 COMPLETED
HIV Infections
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
2005-09 PHASE3
NCT00751153 UNKNOWN
HIV Infections
Peter J. Ruane, M.D., Inc.
2008-03 PHASE4
NCT00280969 COMPLETED
HIV Infection
International Medical Center of Japan
2005-09 PHASE3
NCT00385645 COMPLETED
HIV Infections
Hospital Clinic of Barcelona
2006-05 PHASE4
NCT00757783 COMPLETED
HIV
Tibotec, Inc
2008-10 PHASE4
NCT00883935 COMPLETED
Healthy Volunteer
GlaxoSmithKline
2009-04 PHASE1
NCT00260078 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
2006-02 PHASE1; PHASE2
NCT00696722 COMPLETED
Type 2 Diabetes Mellitus Related Endothelial Dysfunction
Radboud University Medical Center
2008-06 PHASE2
NCT00326716 COMPLETED
HIV Infection
Bristol-Myers Squibb
2006-06 PHASE1
NCT00718536 COMPLETED
HIV Infections
Germans Trias i Pujol Hospital
2008-08 PHASE4
NCT00413153 COMPLETED
HIV Infections
Massachusetts General Hospital
2006-05
NCT00528060 COMPLETED
HIV Infections
French National Agency for Research on AIDS and Viral Hepatitis
2008-01 PHASE2
NCT00646776 COMPLETED
Antivirals/HIV
Bristol-Myers Squibb
2008-04 PHASE1
NCT00225017 COMPLETED
HIV Infection; Hyperlipidemia
Northwestern University
2005-06 PHASE3
NCT01388543 COMPLETED
HIV
University of Colorado, Denver
2006-09 PHASE4
NCT00337467 COMPLETED
Human Immunodeficiency Virus (HIV) Infections
Bristol-Myers Squibb
2006-06 PHASE3
NCT00355719 COMPLETED
HIV Infections
Germans Trias i Pujol Hospital
2007-01 PHASE4
NCT00411957 COMPLETED
HIV Infections
The HIV Netherlands Australia Thailand Research Collaboration
2007-01 PHASE1; PHASE2
NCT00518297 COMPLETED
HIV Infections
Bristol-Myers Squibb
2007-08 PHASE1
NCT00384904 COMPLETED
HIV Infections
Bristol-Myers Squibb
2006-12 PHASE4
NCT00420355 TERMINATED
HIV Infection
University of Oklahoma
2007-04 PHASE4
NCT00207142 COMPLETED
HIV Infections
Bristol-Myers Squibb
2005-11 PHASE4
NCT00135356 COMPLETED
HIV-Associated Lipodystrophy Syndrome
Bristol-Myers Squibb
2005-07 PHASE4
NCT00272779 COMPLETED
HIV Infections
Bristol-Myers Squibb
2005-11 PHASE3
NCT00160329 COMPLETED
Hyperlipidemia; HIV Infections
Stanford University
2004-01 PHASE3
NCT00312754 TERMINATED
HIV Infections
Bristol-Myers Squibb
2005-06 PHASE4
NCT00224445 COMPLETED
HIV Infections
Gilead Sciences
2005-09 PHASE4
NCT00393328 COMPLETED
HIV Infections
Bristol-Myers Squibb
2006-11 PHASE1
NCT00362726 COMPLETED
HIV Infections
Bristol-Myers Squibb
2006-09 PHASE1
NCT00357604 COMPLETED
HIV Infections
Bristol-Myers Squibb
2006-07 PHASE1
NCT00720590 COMPLETED
Endothelial Dysfunction
Indiana University
2003-11
NCT00357188 COMPLETED
HIV Infections; Protease Inhibitor
Bristol-Myers Squibb
2006-07 PHASE1
NCT00357721 COMPLETED
HIV Infections; Protease Inhibitor
Bristol-Myers Squibb
2006-06 PHASE1
NCT00084253 COMPLETED
HIV Infections
Bristol-Myers Squibb
2004-06 PHASE4
NCT00357240 COMPLETED
HIV Infections
Bristol-Myers Squibb
2006-06 PHASE1
NCT00162149 COMPLETED
HIV Infections
Bristol-Myers Squibb
2005-10 PHASE1
NCT00365339 COMPLETED
HIV Infections
Bristol-Myers Squibb
2006-04 PHASE1
NCT00120393 COMPLETED
HIV Infections
Bristol-Myers Squibb
2004-01 PHASE3
NCT00192608 COMPLETED
HIV Infections
Kirby Institute
2004-11
NCT00082394 COMPLETED
Infection, Human Immunodeficiency Virus I; HIV Infection
GlaxoSmithKline
2004-04-26 PHASE4
NCT00135395 COMPLETED
HIV Infections
Bristol-Myers Squibb
2004-05 PHASE3
NCT00135343 COMPLETED
HIV Infections
Bristol-Myers Squibb
2004-04 PHASE3
NCT02253836 COMPLETED
Healthy
Boehringer Ingelheim
2005-01 PHASE1
NCT00135434 COMPLETED
HIV Infections
Bristol-Myers Squibb
2004-09 PHASE1
NCT00067782 COMPLETED
HIV Infections
Bristol-Myers Squibb
2002-12 PHASE3
NCT02257008 COMPLETED
Healthy
Boehringer Ingelheim
2003-03 PHASE1
NCT00028301 COMPLETED
HIV Infections
Bristol-Myers Squibb
2001-02 PHASE3
NCT00035932 COMPLETED
HIV Infections
Bristol-Myers Squibb
2001-11 PHASE3
NCT00013897 COMPLETED
HIV Infections
Bristol-Myers Squibb
2001-02 PHASE3
NCT00028067 TERMINATED
HIV Infections
Bristol-Myers Squibb
2001-08 PHASE3
NCT00004584 COMPLETED
HIV Infections
Bristol-Myers Squibb
1999-12 PHASE2
NCT00002240 COMPLETED
HIV Infections
Bristol-Myers Squibb
1999-03 PHASE2
NCT00028314 COMPLETED
HIV Infections; Lipodystrophy; Wasting Disease
National Institute of Allergy and Infectious Diseases (NIAID)
2002-03
NCT00122577 TERMINATED
HIV Infections
French National Agency for Research on AIDS and Viral Hepatitis
2002-03 PHASE2
NCT01368783 UNKNOWN
Atazanavir
Asan Medical Center
2011-06 PHASE1
NCT00007202 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
PHASE2
NCT00013520 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
PHASE3
NCT00447070 COMPLETED
HIV Infections; Dyslipidemia
Foundation for Cardiovascular Research, Zurich
2004-08 PHASE4
NCT00389402 COMPLETED
HIV Infections
International Antiviral Therapy Evaluation Center
2006-07 PHASE4
NCT00084019 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
2004-07
NCT00426296 UNKNOWN
HIV Infections; Lipodystrophy
Clinical Alliance for Research & Education - Infectious Diseases, LLC.
2006-08 PHASE4
NCT00096850 COMPLETED
HIV Infections; Tuberculosis
National Institute of Allergy and Infectious Diseases (NIAID)

(data from https://clinicaltrials.gov, updated on 2026-04-21)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Atazanavir selectively binds to and inhibits the HIV-1 protease enzyme, thereby preventing the proteolytic cleavage of viral Gag and Gag-Pol polyprotein precursors into functional structural proteins and essential enzymes. This blockade disrupts mature virion assembly and renders newly produced viral particles immature and non-infectious, ultimately reducing viral load and providing therapeutic efficacy in the management of 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>).

Note: Technical data last updated: Sep 1, 2026.