Clinical Trials

Lopinavir has been evaluated in numerous clinical trials primarily targeting viral pathogens, including HIV-1, HIV-2, COVID-19, SARS-CoV-2, and Hepatitis C co-infections. Spanning Early Phase 1 through Phase 4, these studies are supported by key sponsors such as the National Institute of Allergy and Infectious Diseases, Asan Medical Center, and the University of Kansas Medical Center. Across these evaluations, trial recruitment statuses encompass actively recruiting, completed, terminated, and withdrawn protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06337032 RECRUITING
HIV-1-infection
Gilead Sciences
 2024-08-27 PHASE4
NCT04381936 RECRUITING
Pneumonia
University of Oxford
 2020-03-19 PHASE3
NCT02140255 RECRUITING
HIV Infection
National Institute of Allergy and Infectious Diseases (NIAID)
 2015-01-23 PHASE1; PHASE2
NCT05914116 RECRUITING
Advanced Solid Tumors
DualityBio Inc.
 2023-08-17 PHASE1; PHASE2
NCT07601074 RECRUITING
Human Papilloma Virus (HPV); High-risk Human Papillomavirus Infection
Daré Bioscience, Inc.
 2026-07-17 PHASE2
NCT05334004 RECRUITING
High-Grade Anal Intraepithelial Neoplasia
University of Wisconsin, Madison
 2023-12-19 PHASE1
NCT02735707 RECRUITING
Community-acquired Pneumonia, Influenza, COVID-19
UMC Utrecht
 2016-04-11 PHASE3
NCT05925140 UNKNOWN
COVID-19; Hospitalized COVID-19 Patients
Lebanese University
 2020-03-28 PHASE1
NCT04315948 COMPLETED
Corona Virus Infection
Institut National de la Santé Et de la Recherche Médicale, France
 2020-03-22 PHASE3
NCT04390152 TERMINATED
Acute Respiratory Distress Syndrome
BioXcellerator
 2020-01-13 PHASE1; PHASE2
NCT04372628 COMPLETED
COVID-19
Vanderbilt University Medical Center
 2020-06-01 PHASE2
NCT04351724 UNKNOWN
COVID-19
Medical University of Vienna
 2020-04-16 PHASE2; PHASE3
NCT04499677 COMPLETED
COVID-19
University College, London
 2020-09-24 PHASE2
NCT02712801 COMPLETED
HIV/AIDS and Infections
National Center for Women and Children's Health, China CDC
 2016-04 PHASE4
NCT04455958 WITHDRAWN
Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm; Symptomatic COVID-19 Infection Laboratory-Confirmed
OHSU Knight Cancer Institute
 2021-05-01 PHASE2
NCT04466241 COMPLETED
COVID-19; COVID-19 Drug Treatment; Severe Acute Respiratory Syndrome Coronavirus 2
ANRS, Emerging Infectious Diseases
 2020-11-27 PHASE2; PHASE3
NCT04380818 UNKNOWN
Pneumonia, Viral
Grupo de Investigación Clínica en Oncología Radioterapia
 2020-06-05
NCT04321174 UNKNOWN
Coronavirus Infections; Post-exposure Prophylaxis
Unity Health Toronto
 2020-04-17 PHASE3
NCT04459702 WITHDRAWN
COVID; COVID-19; Corona Virus Infection; Coronavirus Infection; Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere; Coronavirus-19; SARS-CoV 2; SARS Pneumonia
ProgenaBiome
 2020-07 PHASE2
NCT05024006 COMPLETED
Covid19
University of the Philippines
 2020-04-23
NCT04738045 UNKNOWN
Covid19
Ahmed Essam
 2020-11-01 PHASE4
NCT04364022 COMPLETED
Prevention of COVID-19
Calmy Alexandra
 2020-04-23 PHASE3
NCT04779047 UNKNOWN
Covid19; Pneumonia
October 6 University
 2020-10-01 PHASE4
NCT04286503 UNKNOWN
Novel Coronavirus Infectious Disease (COVID-19)
Beijing YouAn Hospital
 2020-02-23 PHASE4
NCT04403100 UNKNOWN
COVID-19; Coronavirus Infection; Virus Disease; Acute Respiratory Infection; SARS-CoV Infection
Cardresearch
 2020-06-03 PHASE3
NCT04251871 UNKNOWN
Pneumonia Caused by Human Coronavirus (Disorder)
Beijing 302 Hospital
 2020-01-22
NCT04409483 WITHDRAWN
Covid-19
Epicentre
 2020-06-01 PHASE3
NCT04365582 WITHDRAWN
COVID
Fondation Hôpital Saint-Joseph
 2020-05-07 PHASE3
NCT04394182 SUSPENDED
Pneumonia, Viral; Cytokine Storm
Fundacion GenesisCare
 2020-04-21
NCT04354428 TERMINATED
COVID-19; SARS-CoV-2
University of Washington
 2020-04-16 PHASE2; PHASE3
NCT04521400 UNKNOWN
Covid19
Shahid Beheshti University of Medical Sciences
 2020-08-20 PHASE2
NCT04295551 UNKNOWN
COVID-19
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
 2020-03-14
NCT04255017 UNKNOWN
2019-nCoV
Tongji Hospital
 2020-02-01 PHASE4
NCT03394196 TERMINATED
HIV-2 Infection
University of Washington
 2018-07-04
NCT04386876 COMPLETED
Bioequivalence
World Medicine ILAC SAN. ve TIC. A.S.
 2020-04-30 PHASE1
NCT04328285 TERMINATED
COVID-19
Centre Hospitalier Universitaire de Saint Etienne
 2020-04-14 PHASE3
NCT02845843 COMPLETED
Middle East Respiratory Syndrome Coronavirus (MERS-CoV)
King Abdullah International Medical Research Center
 2016-07 PHASE2; PHASE3
NCT04307693 TERMINATED
COVID-19
Asan Medical Center
 2020-03-11 PHASE2
NCT04252885 COMPLETED
Coronavirus Infections
Guangzhou 8th People's Hospital
 2020-01-28 PHASE4
NCT04343768 COMPLETED
COVID-19
Shahid Beheshti University of Medical Sciences
 2020-04-09 PHASE2
NCT04350684 UNKNOWN
COVID-19
Shahid Beheshti University of Medical Sciences
 2020-04-15 PHASE4
NCT04331470 UNKNOWN
COVID-19
Fasa University of Medical Sciences
 2020-04-04 PHASE2; PHASE3
NCT04350671 UNKNOWN
COVID-19
Shahid Beheshti University of Medical Sciences
 2020-04-15 PHASE4
NCT04261907 TERMINATED
2019-nCoV
First Affiliated Hospital of Zhejiang University
 2020-02-11
NCT04376814 COMPLETED
COVID-19; Favipiravir; Kaletra; Hydroxychloroquine; Lopinavir/Ritonavir
Baqiyatallah Medical Sciences University
 2020-03-29
NCT04335123 Completed
COVID-19
University of Kansas Medical Center
 2020-04-04 Phase 1
NCT04276688 COMPLETED
Novel Coronavirus Infection
The University of Hong Kong
 2020-02-10 PHASE2
NCT04307693 Terminated
COVID-19
Asan Medical Center
 2020-03-11 Phase 2
NCT02415985 COMPLETED
HIV; Tuberculosis
The HIV Netherlands Australia Thailand Research Collaboration
 2015-06 PHASE2
NCT03836833 UNKNOWN
HIV
Drugs for Neglected Diseases
 2019-06-04 PHASE1; PHASE2
NCT02150993 COMPLETED
HIV-2 Infection
ANRS, Emerging Infectious Diseases
 2016-01-26 PHASE2; PHASE3
NCT02346487 COMPLETED
HIV
Drugs for Neglected Diseases
 2015-09 PHASE3
NCT01700790 TERMINATED
AIDS; Tuberculosis
University of Miami
 2016-02 PHASE4
NCT02671383 COMPLETED
HIV Infections
Willem Daniel Francois Venter
 2016-06-30 PHASE3
NCT01125696 COMPLETED
HIV; Hepatitis B
Centers for Disease Control and Prevention
 2012-05 PHASE2
NCT02369965 COMPLETED
HIV Infections; AIDS
Frontier Biotechnologies Inc.
 2014-02-19 PHASE3
NCT02631473 SUSPENDED
HIV
St Stephens Aids Trust
 2015-11 PHASE1
NCT01854762 TERMINATED
HIV; Pregnancy
Fundação Bahiana de Infectologia
 2015-06-01 PHASE2; PHASE3
NCT02227238 COMPLETED
HIV Infections
ViiV Healthcare
 2014-12-11 PHASE3
NCT01637558 COMPLETED
Tuberculosis; HIV
University of Cape Town
 2012-11 PHASE4
NCT02116660 TERMINATED
HIV Infections
Merck Sharp & Dohme LLC
 2014-09-03 PHASE2
NCT03070470 COMPLETED
Drug-induced QT Prolongation; Pharmacokinetics; Pharmacodynamics
Food and Drug Administration (FDA)
 2017-03-14 PHASE1
NCT01818258 COMPLETED
HIV Positive; Malnourished
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
 2015-10-26 PHASE4
NCT01601626 TERMINATED
HIV Infection; Tuberculosis
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
 2013-07-13 PHASE2
NCT02348177 COMPLETED
Acquired Immunodeficiency Syndrome; Tuberculosis
Drugs for Neglected Diseases
 2013-01 PHASE4
NCT01061151 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2011-03-01 PHASE3
NCT02198443 COMPLETED
HIV
Fundacion Clinic per a la Recerca Biomédica
 2015-06-06 PHASE4
NCT02219672 UNKNOWN
AIDS/HIV PROBLEM
Peking Union Medical College
 2014-07 PHASE3
NCT01632891 COMPLETED
HIV-1 Infection; Pf Subclinical Parasitemia
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
 2014-01-10 PHASE1; PHASE2
NCT01905059 COMPLETED
HIV Infection
ANRS, Emerging Infectious Diseases
 2014-02 PHASE3
NCT01003990 COMPLETED
HIV
Bristol-Myers Squibb
 2002-10 PHASE3
NCT01138202 COMPLETED
HIV Infections; Tuberculosis
The HIV Netherlands Australia Thailand Research Collaboration
 2010-11 PHASE2
NCT00981318 TERMINATED
HIV Infections; Acquired Immunodeficiency Syndrome
Rodwick, Barry M., M.D.
 2009-12 PHASE4
NCT00074581 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2005-02 PHASE3
NCT01146873 COMPLETED
HIV/AIDS; HIV Infections
Columbia University
 2010-07 PHASE3
NCT01352715 COMPLETED
HIV-1 Infection
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
 2012-03-13 PHASE3
NCT02203461 COMPLETED
Insulin Resistance
Technical University of Munich
 2014-07 PHASE1
NCT01453933 UNKNOWN
HIV Infection; Endothelial Dysfunction
UMC Utrecht
 2012-01 PHASE4
NCT01154673 COMPLETED
Acute HIV Infection
University of Toronto
 2011-11 PHASE2; PHASE3
NCT01192035 COMPLETED
HIV-1
University of Aarhus
 2011-05 PHASE4
NCT01738555 WITHDRAWN
Human Immunodeficiency Virus Infection
RFS Pharma, LLC
 2013-04 PHASE2
NCT01576731 COMPLETED
HIV Infection
Hospital Clinic of Barcelona
 2012-07 PHASE4
NCT02159352 COMPLETED
Hepatitis C
Bristol-Myers Squibb
 2014-06 PHASE1
NCT01581853 COMPLETED
HIV
Daniel Podzamczer
 2012-05 PHASE4
NCT01533272 COMPLETED
HIV Infection
Hospital Clinic of Barcelona
 2012-02 PHASE4
NCT01471821 COMPLETED
HIV Infection
Juan A. Arnaiz
 2011-10 PHASE4
NCT02097381 UNKNOWN
HIV Infection
University of Roma La Sapienza
 2010-04
NCT01671982 COMPLETED
HIV
Institut de Recherche pour le Developpement
 2012-08 PHASE1
NCT01663168 UNKNOWN
HIV; Tuberculosis
Justine Boles
 2011-12 PHASE2
NCT01172535 COMPLETED
HIV
National Institute of Allergy and Infectious Diseases (NIAID)
 2010-11 PHASE2; PHASE3
NCT00928187 COMPLETED
HIV; HIV Infections
ANRS, Emerging Infectious Diseases
 2009-11 PHASE3
NCT01516970 COMPLETED
Human Immunodeficiency Virus (HIV)
Janssen-Cilag G.m.b.H
 2011-11-25 PHASE3
NCT00719602 COMPLETED
HIV Infections; Malaria
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
 2009-08 EARLY_PHASE1
NCT01148004 COMPLETED
HIV; Fenofibrate; Protease Inhibitors; Hypertriglyceridemia; Glucuronosyltransferase
National Institutes of Health Clinical Center (CC)
 2010-05-13 PHASE1
NCT00759070 UNKNOWN
HIV Infections
Juan A. Arnaiz
 2008-09 PHASE4
NCT00946595 COMPLETED
HIV Infections
French National Agency for Research on AIDS and Viral Hepatitis
 2009-11 PHASE2; PHASE3
NCT00993031 COMPLETED
Malaria; HIV Infections
University of California, San Francisco
 2009-12-15 PHASE3
NCT01571414 COMPLETED
Tuberculosis
National Institute of Allergy and Infectious Diseases (NIAID)
 2012-05 PHASE1
NCT00640263 COMPLETED
HIV Infections
French National Agency for Research on AIDS and Viral Hepatitis
 2009-12 PHASE3
NCT01255371 WITHDRAWN
HIV
ANRS, Emerging Infectious Diseases
 2012-03 PHASE3
NCT01307124 COMPLETED
HIV-infected Children
The HIV Netherlands Australia Thailand Research Collaboration
 2011-03 PHASE3
NCT00865475 COMPLETED
HIV Infection; HIV Infections
Fundacion SEIMC-GESIDA
 2008-12 PHASE4
NCT01583439 TERMINATED
HIV Infections
Harvard School of Public Health (HSPH)
 2012-09
NCT00936195 WITHDRAWN
HIV Infection; Pregnancy; Breastfeeding; HIV Infections
French National Agency for Research on AIDS and Viral Hepatitis
 2010-01 PHASE3
NCT00978068 COMPLETED
Malaria; HIV Infections
University of California, San Francisco
 2009-09 PHASE3
NCT01189695 COMPLETED
HIV; AIDS; Lopinavir; Treatment Failure
Bamrasnaradura Infectious Diseases Institute
 2010-12 PHASE4
NCT00532168 COMPLETED
HIV Infections
Juan A. Arnaiz
 2007-09 PHASE4
NCT00771498 COMPLETED
HIV Infection; Tuberculosis
Oswaldo Cruz Foundation
 2008-11 PHASE4
NCT01296152 COMPLETED
HIV-1 Infection
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
 2011-05 PHASE2
NCT01031849 TERMINATED
HIV Infections
Ines Perez
 2010-02 PHASE4
NCT01660477 COMPLETED
Pharmacokinetics of Isavuconazole; Pharmacokinetics of Lopinavir/Ritonavir; Healthy Volunteers
Astellas Pharma Global Development, Inc.
 2012-06 PHASE1
NCT00994344 COMPLETED
HIV Infections
Germans Trias i Pujol Hospital
 2009-10 PHASE4
NCT01513122 COMPLETED
HIV
Kirby Institute
 2010-02 PHASE4
NCT00102960 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2005-07 PHASE3
NCT00608569 COMPLETED
HIV Infections
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
 2009-03
NCT00931463 COMPLETED
HIV Infections
Kirby Institute
 2009-09 PHASE4
NCT00651066 COMPLETED
HIV Infections; Tuberculosis
French National Agency for Research on AIDS and Viral Hepatitis
 2010-06 PHASE2
NCT00605098 COMPLETED
HIV Infections; Pregnancy
Oswaldo Cruz Foundation
 2008-02 PHASE4
NCT01196195 COMPLETED
Antiretroviral Therapy in HIV-1 Infected Children
PENTA Foundation
 2010-08 PHASE2; PHASE3
NCT00865007 COMPLETED
HIV Infection; Lipodystrophy; HIV Infections
Fundacion SEIMC-GESIDA
 2008-12 PHASE4
NCT00866021 COMPLETED
HIV/HCV Co-infection; HIV Infections
Fundacion SEIMC-GESIDA
 2008-02 PHASE4
NCT01237444 COMPLETED
HIV Infection
Pedro Cahn
 2010-12 PHASE3
NCT02404259 COMPLETED
HIV
The HIV Netherlands Australia Thailand Research Collaboration
 2010-06
NCT00444379 COMPLETED
Kaposi's Sarcoma; HIV Infections
University of California, San Francisco
 2007-04 PHASE4
NCT01294761 COMPLETED
HIV Infections
National Center for Global Health and Medicine, Japan
 2011-02
NCT00654147 COMPLETED
HIV Infections
Margaret A. Fischl, M.D.
 2008-04 PHASE2
NCT01166477 COMPLETED
HIV Infection
Sociedad Andaluza de Enfermedades Infecciosas
 2010-01 PHASE4
NCT00802334 COMPLETED
HIV
The HIV Netherlands Australia Thailand Research Collaboration
 2008-01 PHASE2
NCT01088516 COMPLETED
HIV
University of Zambia
 2008-12 PHASE4
NCT01772940 COMPLETED
HIV-1 Infection
Centre Hospitalier Universitaire Saint Pierre
 2008-12 PHASE4
NCT00234091 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2006-04 PHASE3
NCT00424814 COMPLETED
HIV Infections
ANRS, Emerging Infectious Diseases
 2007-03 PHASE2; PHASE3
NCT00573001 COMPLETED
HIV Infections
French National Agency for Research on AIDS and Viral Hepatitis
 2008-07 PHASE3
NCT01231451 WITHDRAWN
HIV Infection
St Stephens Aids Trust
 2010-12 PHASE1
NCT00756730 COMPLETED
HIV Infections
Community Research Initiative of New England
 2008-09 PHASE4
NCT01116817 COMPLETED
HIV
Germans Trias i Pujol Hospital
 2010-08 PHASE4
NCT00752856 COMPLETED
HIV Infections
University of California, San Diego
 2008-08-26 PHASE2
NCT01165645 WITHDRAWN
Hodgkin Lymphoma; Stage I Adult Hodgkin Lymphoma; Stage II Adult Hodgkin Lymphoma; Stage III Adult Hodgkin Lymphoma; Stage IV Adult Hodgkin Lymphoma
Mayo Clinic
 2010-11
NCT01139905 COMPLETED
HIV-1 Infections
The HIV Netherlands Australia Thailand Research Collaboration
 2010-04 PHASE2
NCT01002898 COMPLETED
HIV
Bamrasnaradura Infectious Diseases Institute
 2007-04 PHASE3
NCT01227590 COMPLETED
Drug Interactions; Human Immunodeficiency Virus
University of California, San Francisco
 2010-02 PHASE1
NCT00103012 COMPLETED
Healthy
National Institutes of Health Clinical Center (CC)
 2005-01 PHASE4
NCT01057433 COMPLETED
Healthy Volunteers
Kowa Research Institute, Inc.
 2010-01 PHASE4
NCT00775606 TERMINATED
Acquired Immune Deficiency Syndrome
Rush University Medical Center
 2008-10 PHASE4
NCT00307151 COMPLETED
HIV Infections
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
 2005-12 PHASE2
NCT00525239 UNKNOWN
HIV Infections
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2004-03
NCT01068873 TERMINATED
HIV Infections
Temple University
 2010-04 PHASE4
NCT00266058 COMPLETED
HIV Infections; Malaria
University of California, San Francisco
 2005-12 PHASE1
NCT00409591 TERMINATED
HIV Infections; Pregnancy
Institut de Recherche pour le Developpement
 2008-07 PHASE3
NCT00357552 COMPLETED
HIV Infections
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
 2008-01
NCT00640887 COMPLETED
HIV Infections; Tuberculosis
French National Agency for Research on AIDS and Viral Hepatitis
 2009-02 PHASE2
NCT00089505 COMPLETED
HIV Infections
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
 2006-11 PHASE3
NCT00437684 UNKNOWN
HIV Infections; Hepatitis C
IRCCS San Raffaele
 2007-02 PHASE3
NCT00437476 UNKNOWN
HIV Infections; Hepatitis C
IRCCS San Raffaele
 2007-02 PHASE3
NCT00765154 TERMINATED
HIV
St Stephens Aids Trust
 2008-10 PHASE4
NCT00949234 COMPLETED
HIV Prevention; HIV Infections
University of California, Los Angeles
 2010-03 PHASE2
NCT01095094 TERMINATED
Brain Tumor; Anaplastic Astrocytoma; Anaplastic Ependymoma; Anaplastic Oligodendroglioma; Brain Stem Glioma; Giant Cell Glioblastoma; Glioblastoma; Gliosarcoma; Mixed Glioma
Case Comprehensive Cancer Center
 2009-01 PHASE2
NCT00752037 COMPLETED
HIV Infections
Saint Michael's Medical Center
 2008-09 PHASE4
NCT00099632 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2006-03 PHASE2
NCT00100646 COMPLETED
HIV Infections
The Wistar Institute
 2007-03
NCT01159275 COMPLETED
HIV-1 Infections
The HIV Netherlands Australia Thailand Research Collaboration
 2009-07 PHASE1; PHASE2
NCT00632970 TERMINATED
HIV Infections
George Washington University
 2008-02 PHASE4
NCT00869700 COMPLETED
HIV Infections; Malaria
University of Cape Town
 2009-06 PHASE4
NCT00414518 COMPLETED
HIV Infections
University of Colorado, Denver
 2007-01
NCT00164736 COMPLETED
HIV Infections
Centers for Disease Control and Prevention
 2004-03 PHASE3
NCT00985543 COMPLETED
Acquired Immunodeficiency Syndrome
Kirby Institute
 2009-10 PHASE1
NCT00159224 COMPLETED
HIV Infections
Fundación Huésped
 2005-04 PHASE4
NCT01049685 UNKNOWN
HIV Infections
UPECLIN HC FM Botucatu Unesp
 2006-08 PHASE4
NCT00307502 COMPLETED
HIV Infections
Germans Trias i Pujol Hospital
 2005-01 PHASE1
NCT00302822 COMPLETED
HIV Infections; AIDS
French National Agency for Research on AIDS and Viral Hepatitis
 2006-04 PHASE3
NCT01445223 COMPLETED
HIV
Göteborg University
 2004-04 PHASE4
NCT00621166 COMPLETED
HIV Infections
The HIV Netherlands Australia Thailand Research Collaboration
 2008-06 PHASE2
NCT00945282 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2009-10-20 PHASE2
NCT00920088 COMPLETED
Healthy Subjects; Infection, Human Immunodeficiency Virus
GlaxoSmithKline
 2009-06 PHASE1
NCT00711009 COMPLETED
Human Immunodeficiency Virus Infection
Abbott
 2008-07 PHASE3
NCT00626301 COMPLETED
HIV Infections
The HIV Netherlands Australia Thailand Research Collaboration
 2007-11 PHASE4
NCT00772902 COMPLETED
HIV-1
Gilead Sciences
 2008-10 PHASE4
NCT00885664 COMPLETED
HIV Infections
University of Cincinnati
 2005-10 PHASE4
NCT00385645 COMPLETED
HIV Infections
Hospital Clinic of Barcelona
 2006-05 PHASE4
NCT00834457 COMPLETED
AIDS-related Kaposi's Sarcoma
Parirenyatwa Hospital
 2007-06 PHASE2; PHASE3
NCT00090779 TERMINATED
HIV Infections
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
 2005-01 PHASE2
NCT00810108 COMPLETED
HIV/AIDS Treatment; HIV Infections
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 2006-06 PHASE4
NCT00344487 TERMINATED
HIV
University of Maryland, Baltimore
 2005-12
NCT00867152 COMPLETED
Healthy Volunteer
ViiV Healthcare
 2009-04 PHASE1
NCT00427297 TERMINATED
HIV Infections
University of Washington
 2007-09 PHASE3
NCT00828529 COMPLETED
Tuberculosis; HIV
Tibotec BVBA
 2009-02 PHASE1
NCT00443703 TERMINATED
HIV Infection
Merck Sharp & Dohme LLC
 2007-05 PHASE3
NCT00836212 UNKNOWN
Human Immunodeficiency Virus; HIV Infections
University Hospital, Geneva
 2008-03 PHASE4
NCT00833378 COMPLETED
Hepatitis C
GlaxoSmithKline
 2009-01-19 PHASE1
NCT00270296 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2006-06 PHASE2
NCT00438152 COMPLETED
HIV Infections
Royal Free Hampstead NHS Trust
 2006-09 PHASE4
NCT00665951 COMPLETED
HIV Infections
Radboud University Medical Center
 2008-09 PHASE1
NCT00255840 COMPLETED
HIV Infections
CIPRA SA
 2006-07
NCT00887120 COMPLETED
HIV Infections
The HIV Netherlands Australia Thailand Research Collaboration
 2007-04 PHASE2
NCT00697892 COMPLETED
HIV Infections; Malaria
Fran Aweeka
 2005-07 PHASE1
NCT00661349 TERMINATED
HIV Infections
Germans Trias i Pujol Hospital
 2008-02 PHASE4
NCT00767117 COMPLETED
HIV
Tibotec Pharmaceuticals, Ireland
 2008-09 PHASE1
NCT00774735 COMPLETED
Healthy Subjects; Infection, Human Immunodeficiency Virus
GlaxoSmithKline
 2008-10 PHASE1
NCT00966160 COMPLETED
Acquired Immunodeficiency Syndrome; HIV Infections
University of Cologne
 1999-01 PHASE3
NCT00413153 COMPLETED
HIV Infections
Massachusetts General Hospital
 2006-05
NCT00619944 COMPLETED
HIV Infections
Makerere University
 2008-02 PHASE4
NCT00723775 COMPLETED
Infection, Human Immunodeficiency Virus
GlaxoSmithKline
 2008-07-24 PHASE1
NCT00476359 COMPLETED
HIV Infections
The HIV Netherlands Australia Thailand Research Collaboration
 2003-10 PHASE4
NCT00358917 COMPLETED
Human Immunodeficiency Virus Infections
Abbott
 2006-08 PHASE3
NCT00109590 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2006-06 PHASE2
NCT00443729 TERMINATED
HIV Infection
Merck Sharp & Dohme LLC
 2007-05 PHASE3
NCT00743470 TERMINATED
HIV; Tuberculosis
Abbott
 2008-08 PHASE1
NCT00531986 TERMINATED
HIV Infections
Cantonal Hospital of St. Gallen
 2007-01 PHASE4
NCT00531999 COMPLETED
HIV Infections
St Stephens Aids Trust
 2007-10 PHASE1
NCT00571961 COMPLETED
HIV Infections
Yale University
 2007-01
NCT00474201 COMPLETED
Healthy Volunteers
National Institutes of Health Clinical Center (CC)
 2007-05
NCT00262522 COMPLETED
Human Immunodeficiency Virus Infections
Abbott
 2005-11 PHASE3
NCT00342355 COMPLETED
HIV
National Institutes of Health Clinical Center (CC)
 2004-01 PHASE4
NCT00143689 COMPLETED
HIV; Mitochondrial Toxicity
University of British Columbia
 2002-04 PHASE4
NCT00084149 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2004-02 PHASE2
NCT00234975 COMPLETED
HIV Infection
AbbVie (prior sponsor, Abbott)
 2002-10 PHASE4
NCT00140751 COMPLETED
HIV Infections
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
 2005-10 PHASE3
NCT00564772 COMPLETED
Healthy
Allina Health System
 2007-11 PHASE4
NCT00281606 COMPLETED
HIV Infection
University of California, San Diego
 2006-02-14 PHASE4
NCT00420355 TERMINATED
HIV Infection
University of Oklahoma
 2007-04 PHASE4
NCT00294372 TERMINATED
HIV Infections
Boehringer Ingelheim
 2006-02 PHASE2
NCT00102778 TERMINATED
Infection, Human Immunodeficiency Virus I; HIV Infection
ViiV Healthcare
 2004-12 PHASE2
NCT00105079 COMPLETED
HIV Infections
Hoffmann-La Roche
 2005-04 PHASE3
NCT00234910 COMPLETED
HIV Infection
Abbott
 2005-01 PHASE3
NCT00272779 COMPLETED
HIV Infections
Bristol-Myers Squibb
 2005-11 PHASE3
NCT00414284 TERMINATED
HIV Infections
Community Research Initiative of New England
 2006-06 PHASE4
NCT00234923 COMPLETED
HIV Infection
Abbott
 2003-08 PHASE3
NCT00148759 COMPLETED
HIV Infections
Emory University
 2005-06 PHASE4
NCT00648999 COMPLETED
Human Immunodeficiency Virus
AbbVie (prior sponsor, Abbott)
 2003-11 PHASE4
NCT00192621 COMPLETED
HIV Infections; Dyslipidemias; Glucose Metabolism Disorders; Metabolic Diseases; Lipodystrophy; Cardiovascular Disease
Kirby Institute
 2004-11 PHASE4
NCT00400738 COMPLETED
HIV Infections
The HIV Netherlands Australia Thailand Research Collaboration
 2004-03 PHASE2
NCT00144105 TERMINATED
HIV Infections
Boehringer Ingelheim
 2004-02 PHASE2
NCT00055120 COMPLETED
HIV Infections; AIDS-Related Opportunistic Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2003-03 PHASE4
NCT00720590 COMPLETED
Endothelial Dysfunction
Indiana University
 2003-11
NCT00335686 COMPLETED
HIV Infections
Germans Trias i Pujol Hospital
 2003-10 PHASE4
NCT00135395 COMPLETED
HIV Infections
Bristol-Myers Squibb
 2004-05 PHASE3
NCT00100984 TERMINATED
HIV Infection
Hoffmann-La Roche
 2004-07-21 PHASE4
NCT00184951 COMPLETED
HIV Infections; Hyperlipidemia
Radboud University Medical Center
 2004-04 PHASE2
NCT00135434 COMPLETED
HIV Infections
Bristol-Myers Squibb
 2004-09 PHASE1
NCT00004578 COMPLETED
HIV Infections
Abbott
 1997-11 PHASE1; PHASE2
NCT00014937 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00056641 COMPLETED
HIV Infections
Boehringer Ingelheim
 2003-02-18 PHASE2
NCT00028301 COMPLETED
HIV Infections
Bristol-Myers Squibb
 2001-02 PHASE3
NCT00035932 COMPLETED
HIV Infections
Bristol-Myers Squibb
 2001-11 PHASE3
NCT00046033 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00086359 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2004-07 PHASE3
NCT00004582 COMPLETED
HIV Infections
ViRx
 PHASE2
NCT00386659 TERMINATED
HIV Infection
Hospital Clinic of Barcelona
 PHASE4
NCT00038636 COMPLETED
HIV Infections
Abbott
 2000-09 PHASE3
NCT00125983 COMPLETED
HIV Infections; Pregnancy
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00050895 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT00038480 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00023218 WITHDRAWN
HIV Infections; Hepatitis C
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00121017 WITHDRAWN
HIV Infection; Hepatitis C
Abbott
 PHASE2
NCT00004580 COMPLETED
HIV Infections
Abbott
 PHASE1
NCT00139178 COMPLETED
HIV Associated Lipodystrophy Syndrome.; HIV; Hypercholesterolemia; Lipoatrophy
Danish HIV Research Group
 2004-03 PHASE4
NCT00004583 COMPLETED
HIV Infections
Abbott
 1999-03 PHASE3
NCT00028314 COMPLETED
HIV Infections; Lipodystrophy; Wasting Disease
National Institute of Allergy and Infectious Diseases (NIAID)
 2002-03
NCT00234962 TERMINATED
HIV Infection
Abbott
 2002-08 PHASE4
NCT00080522 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2005-02
NCT00038220 COMPLETED
HIV Infections
Abbott
 2000-07 PHASE2
NCT00038532 COMPLETED
HIV Infections
Abbott
 2001-04 PHASE2
NCT00025727 UNKNOWN
HIV Infections
GlaxoSmithKline
 2001-05 PHASE3
NCT00044837 TERMINATED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00102986 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2005-10
NCT00084058 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1; PHASE2
NCT00017992 UNKNOWN
HIV Infections
Triangle Pharmaceuticals
 PHASE2
NCT00038519 COMPLETED
HIV Infections
Abbott
 2001-04 PHASE2; PHASE3
NCT00036452 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00006144 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2000-10 PHASE2
NCT00076414 COMPLETED
Healthy
National Institutes of Health Clinical Center (CC)
 2004-01 PHASE1
NCT00075907 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2004-07 PHASE3
NCT00114933 COMPLETED
HIV Infection
Arribas, Jose R., M.D.
 2005-01 PHASE4
NCT00162643 UNKNOWN
Acquired Immunodeficiency Syndrome
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
 2004-12 PHASE4
NCT00116636 COMPLETED
HIV Infections
Therapeutic Concepts
 2005-06 PHASE2
NCT00028366 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00247143 UNKNOWN
HIV; AIDS
Lampiris, Harry W., M.D.
 2005-10
NCT00102206 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00043966 COMPLETED
HIV Infections
Abbott
 2002-07 PHASE3
NCT00144833 TERMINATED
HIV-1
GlaxoSmithKline
 2005-03 PHASE3
NCT00004581 COMPLETED
HIV Infections
Abbott
 PHASE3
NCT00122590 TERMINATED
HIV Infections
French National Agency for Research on AIDS and Viral Hepatitis
 2002-07
NCT00034086 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00100581 COMPLETED
HIV Infections; Hepatitis C
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00043953 COMPLETED
HIV Infections
Abbott
 2002-08 PHASE2
NCT00578825 UNKNOWN
Severe Acute Respiratory Syndrome
Hospital Authority, Hong Kong
NCT00004855 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00160849 COMPLETED
HIV Infections
Universidade Federal do Rio de Janeiro
 2004-08 PHASE4
NCT00196625 COMPLETED
HIV Infections
ANRS, Emerging Infectious Diseases
 2000-11 PHASE2
NCT00075231 COMPLETED
HIV Infections
Abbott
 2003-12 PHASE2
NCT00122226 UNKNOWN
HIV Infections; HIV-Associated Lipodystrophy Syndrome
Amsterdam UMC, location VUmc
 2003-01 PHASE4
NCT00027339 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2

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

Check the Lopinavir (ABT-378) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lopinavir selectively binds to the active site of HIV protease with a Ki of 1.3 pM, inhibiting enzymatic catalytic activity and preventing the proteolytic cleavage of viral polyprotein precursors. This block in polyprotein processing halts the maturation of viral particles to generate immature, non-infectious virions, which underlies its therapeutic efficacy in managing HIV infections and investigating acute viral conditions like COVID-19.

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.